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Journey of Your Publication: Clinical trials to Practice

May 20 | 3:30 PM

Clinical trials and practise are clinical research experiments. These biomedical experiments and related research investigations aid in the development of innovative therapies and treatments in a variety of medical fields. Let's take a closer look at clinical trials in practise. What the voyage entails, as well as some key biostatistical characteristics. Join us live with a top Medanta researcher.

[Music] uh good evening everyone i'm dr navita and i welcome you all on behalf of team netflix for tonight's session we have with us dr pooja sharma she is the principal consultant with this team research and innovation uh steam research innovation and medical excellence unit an advisor with the medanta institute of education and research and the former director and head medanta institute of education and research she's a clinician researcher and a research enabler with 23 years of expertise she's she has spearheaded the establishment of two government of india dsir recognized um units in uh units one at society for applied studies and the other one at uh medanta institute of education and research uh she is uh strongly committed to bioethics and is a strong advocate for patients awareness of research and presenting to you and with all yours thank you so much i'm excited to share with my dear doctors and i'm very happy to see so many of them actually there let's talk about clinical trials research and practice the team here gave me a topic about a unilateral movement of clinical trials they said about how research impacts practice we're going to talk about actually both we've all been reading medicine so when you're trained in medicine we talk only about evidence-based medicine modern medicine is based on evidence so evidence based practice is based on three things one is the clinical expertise you have the patient's values and preferences so what does the patient want to do in his disease scenario and what is the best research evidence these three factors actually combine to define what is practice that we are supposed to practice which is evidenced based medicine i would like to share with you research and practice cycles so it's not a singular way of you know movement that research is is included into practice it's a continuum cycle so whenever you're seeing a patient there's a question that arises in your heart there's a question that arises in your mind when you see that problem repeatedly you start asking that question to yourself and i'm sure most of us are doing this in practice so that's how the you know non you know traditional the change in medicine actually begins when you start asking these questions so the first you start asking question can this be better can we do something for the patient when you start searching for evidence that evidence is then critically appraised you look at then what's called clinical research or clinical trials and you start applying these results look at how the outcomes are which is also process of research and then modify it in case if it's needed and again start with another research question so it's a complete cycle it is not something that's done in silos research and clinical practice go hand in hand just focusing a little bit more about the process flowing research so how does a research question arise it's something that you face every day in practice you think about it there is the question and therefore the ideation you look at what is the correct methodology to answer this question so we'll go through an example of what we've seen recently the the several covert research studies look at what is the right methodology to actually answer your research question how do you define the protocol this is one bucket of activities that needs to be done then the next bucket of activities is ethics that is that actually drive the research what are the regulations how do you actually operationalize the research and how do you then publish and disseminate the research because unless and until dissemination of research happens the research cycle is not completed so earlier dissemination and publication research meant talking to your peer publishing in a you know presenting in a conference or publishing in in a peer-reviewed journal but today dissemination also means dissemination to the public it means talking in the newspaper it means putting it out there on the news channels putting it out in patient language for the patient to understand so the philosophy of research if i may start with what is the philosophy of research why i do research at all why clinicians should look at research because research is finally all about the truth so if your research question and finding the truth about your research question is going to make a difference to human health and outcome that that is something that is needed to be done now whether you do it or another clinician does it but it will be done so that in my mind is the philosophy of why research should be done just before this nivelita was asking me your clinician you're a gynecologist and how did you manage to get into research this is what actually drove me so let's look at history the historical perspective of research and ethics you know it's it's important to look at history just so one we share don't repeat the mistakes we made in history and if we can learn from it even the better so you know this is just observational i mean all of us have read this as a part of our bioethics training or our general medicine training you know that james lynn treated scurvy by supplementing diet with citrus fruits he was on on one of those ships and they his sailors were falling sick of scurvy and he realized that if he could give them orange juice they became better this was an observation this was a problem that he faced he was a surgeon on a ship he faced the problem he observed something and he started using it so research is just this right you finding a question problem in your practice doing some information some testing to see what can be done of course we have also learned about joseph blister and his use of carbolic acid as an antiseptic on surgical wounds so this is something that that could have been done at that time today's world i don't think you can really do this this is another example that you cannot do in today's world for sure so edward jenner vaccinated an eight-year-old son of his gardener with a cowbox costume products he actually deliberately then infected the child with smallpox to see if he could develop disease so while this was the beginning of vaccines this is not something that you can do today but the fact is what you can do today is possibly things that may not be allowed 200 years from now but unless until those changes are made research is healthcare is never going to change and the needle of healthcare can only be changed with research but i would like to underline that ethics is critical part of the process of research since there has been medicine there has been advancement with research and over and over again the discussion of ethics and the processes of research how do we define the methodology of research have been done all over the world and whether it was hypocrites this was something being discussed everywhere in the world let's start at something which is a more recent history this is again something that you know um it's a very traditional concern that is is usually discussed in research uh ethics discussions so you know look at nazi experiments the and the nuremberg in 1947 so nazi experiments were actually the nazis had their own science their own question their you know they had they had scientists who were actually asking these questions so but it was absolutely unethical as it was discussed and identified in the trial of urine work and one criteria that came out there that there needs to be a scientific basis for research on human subjects and that voluntary consent and protection of participants is a critical part and this is something that we must always remember when we are doing research what happens that the researcher tends to focus so closely that he sometimes loses perspective that there is a human being on the other side of the magnifying glass let's look at the thalidomide tragedy and then so every time you know we learn we learn from a mistake that we make we make a correction we make a mistake we make a correction so if you go back we made a mistake with the nazis the nuremberg court came out then there was the thalidomide tragedy and the gopher harris amendments came out thalidomide just to recap was a tranquilizer and a painkiller it was considered a wonder drug for insomnia colds and headaches and actually use an antibiotic in for you know improving pregnant pregnant hyperemesis and vomiting so many women actually took this to relieve symptoms and several children were born with focal media as you can see in the lower picture there finally came what's called the declaration of helsinki so even today when researchers write their research protocols they must say that we will be compliant with the principles of the declaration of helsinki so while this was first written in 1964 the current version is in 2013 and this is something is completely relevant even today there are basically there are three ethical principles so there is importance of the health of the participant there is definitely consent and then there is [Music] protection of the human participant these are the three principles in the belmont report this is another ethical principle all of them are underlying the same thing there must be respect for persons so there is a dignity and freedom of refusal so there should be an option for the person to make you know a choice to not participate there should be benefit to the participant it should not be just benefit to the community but the individual patient's benefit the risk to the individual patient the benefit to the individual patient and to the community so these are two that must be balanced it cannot be that the risk to the patient is so high that there is no benefit potential benefit also so that is something that is has to be balanced and ethics committees look at this very carefully the third principle is justice this is something that is talking about equitable selection and this is something that has been off discussed in in research forum whenever you look at you know the discussion on on human guinea pigs so there is always this discussion of poorer countries participating more in research because the risk can be taken is higher so this is something that ethics committees as a community doctors as well as the patient community must take very very clear understanding of and that's why research is very important to be understood by not only doctors but also by the patients themselves so there has to be a philosophy of research which you understand before you even uh look at you know actually the methodology of research so it's not as if all all the problems only happened in the us or and that you know that all this learning came from europe and us only the learning even came from here there have been several trigger events even in the indian story with again ethical milestones response there's an event there's a response event response so there have been uh the stories that even more recent is the cervical dysplasia study that resulted in the ethics committee and the icmr ethical policies the hpv trials which resulted in smr ethical guidelines there was a parliamentary committee report due to an investigational study in 2005 and 12 that actually resulted in several amendments to the ship why which is what is of the drugs and cosmetic act which actually covers the clinical trials in india final tenet if you if you have to look at research in a very very basic thing in india you have to remember that what you need to follow is the indian gcp the indian gcp is again in very much in compliance with the three principles of the belmont report so that's again protection of the rights of the human subjects and authenticity of the biomedical data so the other national guidelines just to recap are the national ethical guidelines of icmr and there is currently in the over 19 there because there have been a lot of expedited drug development that they came up you know review guideline even for that during the uh the pandemic and of course there's the new drugs and clinical trials rules which is something that is relevant for clinical trials and regulatory styles with all this history let's flash forward to today you know uh let's just i'm just going to use the corona story to exemplify what we've talked about and this is a very nice drawing that i really liked by a colleague friend of mine talking about the doctors women doctors in india who actually spearheaded and led clinical patient care in in the times so the story in india began march 5th with 14 italians patients with coronavirus being shifted to the hospital after a government request and uh in another few days we actually managed to have the who actually managed to respond with declaration of international worldwide pandemic so interestingly i must say that the response of the indian government actually started even before this so it was in in march that they actually started the grant which was for development of sites for vaccine development so by march february march they had actually prepared already for vaccine development clinical trials and research even before the who had declared the pandemic the indian government was more prepared by march 24th there was a national lockdown there was an unprecedented situation clinicians were working blind okay people do these discussions you know they were my clinical partners and they were my pharmacology partners and there were people from the government team school in the evening and at the end of the day at around 10 p.m 11 p.m we would be sitting in a huddle talking about and you know this is a virtual huddle at that time so you would sit down and you would be wondering whether we should give xcqs not give execus is it a good thing bad thing so it was a very blind situation and that's what actually research is all about in clinical practice when you're in a situation in a bind there's a research question how do you solve it okay this is done so we actually started by creating a covert command team there was of course the you know medicine and ico teams which were the clinical frontline teams there was the administration teams which actually got things together and very critically the data and research teams these guys would actually help with matrix and outcomes to completely course correct so if you will see if you remember i'm sure all of us do of the different stories so there was first hcqs should be given there was whole hoarding of xcqs and then there was no need for hcqs because it's us wasn't doing so great then next game whether convalescent plasma is a good thing or a bad thing that the steroids should be given not given so unless and until data was there in real time in research was available to you clinical metrics would not have improved physicians of course turned forward warriors the challenges of covet which is what the challenges of actually practice looking to research for solutions is that there is a unknown natural history or force of disease there is unknown disease management is fighting completely in the dark this is a moving target you are looking at a disease which is continuously changing presentations and continuously mutating you don't know what's going to happen is it going to be delta variant or the omega variant or the omicron variant which one is going to be there was of course the story of the vaccines which we shall possibly talk i just mentioned about it but vaccines maybe is a discussion for another day whether they work whether there's hesitancy chaos mix and match whether the government is doing enough or is it doing too much so research actually on so when my my parents used to wonder are you a researcher why do you have to go to the hospital still so interestingly while many clinical teams were sitting at home surgeons were sitting at home the research teams were all actually there hands on so the with the front line teams i must and today by the way is the international clinical trials day so shout out to all my clinical research workers and teams who all over the country all over the world have really worked hard not only in covet but in so many other conditions and they're continuing to do so being in the background never much being appreciated for it so research actually became the guidewire 40 projects at the word so or in march we had started 40 clinical research studies which included what we call outcome research studies so outcome research studies are observational studies just looking at whether you know what action we've taken is it in line with benefit that we had thought so like we did for hcqs for you know at that time vitamin c was a big thing zinc there was either the ayurvedic drugs all over the place we even tried sudarshan kriya you name it and we did a research on that we published them in several so if you will just google it with miranda institute of education and research you will find those we started doing clinical patient outcomes and mapping of the medicines so each medicine because what happened was that you know unless and until you looked at indian patients there was a lot of genetic variation if we started actually with profiling patients so when patients in the other countries were presenting with sore throat and more respiratory symptoms indian patients started presentation with gastrointestinal symptoms so it was a different presentation but then suddenly we transformed into upper respiratory infection so it was a lot of observation it's like you know you are going blind but the research team is sort of helping you find out okay it was a very interesting time we of course did you know several efforts to integrate ayurvedic medicines into the exercise we noted that change in taste and smell were noted first and you know as well as loose motions and gastrointestinal symptoms were noted first in indian patients we did a profiling of patients according to ayurvedic criteria we did a very scientific study to choose the kind of ayurvedic medicines that should be given so while people's you know there are of course critics of everything and anything but and many times i was on the borderline of ayurvedic medicines being used in modern medicine but over time i realized that you know whatever works for the patient works for the patient so important is patient survival and patient benefit and whether it's modern medicine or ayurveda or homeopathy whichever works for the patient please let it work we created actually working groups with clinical modern medicine teams and ayurvedic teams so we had experts there were five barriers the people from the ayush ministry modern medicine physicians we were all sitting down and defining if we could do a joint collaborative program and we did our first study on inospora that's giloy and as an add-on so what i'm saying is it started off as profiling clinical observational study then it started as at the next step was as add-on therapy to actually see if what we had profiled and what was useful could actually benefit patients so while there was a pandemic going on the teams were very actively still doing methodological rigor it was not something that was done very quickly it was done with great deliberation and the third was the you know uh the scenic phenom which is the the gold standard of clinical research which was a randomized open label study which was done with sponsor from the ayush ministry we believe that you know managing overt was critical with the help of the research radar we explored several drugs there was research around the world actually happening we looked at oscilloscope this was something that our clinical teams so this was not a drug trial that was sponsored by the companies this was driven by the by the doctors so it was a question that was raised by one of the clinicians he was a transplant physician people asked if you know what australia was which was being tested in other countries could be tested in india we thought it was a very high cost study high risk study and it will need regulatory approval but the regulator actually expedited approval within 15 days a month exclude that the approval was given and i must say with complete record so it was not you know the regulator used to sit for long meetings 10 pm 11 pm the regulatory meetings were still going on so i must comment that i mean that's probably one of my concluding slides that that people really rallied through so this uh if effort of ours with the dossiers map was actually then published in in landsat infectious diseases and landsat respiratory medicine and this was one of the applications from india and this was the funds for this were raised through patient support groups through societal members societal groups and of course some support was also given off by giving the drug free by roshan we also work with several diagnostics we work whether you know the library rt pcr because that was the discussion rt pcr not an easy test to do then of course people you know were doing the tests were in so much of a kit it was a very very tedious exercise so whether can we do a simpler test can the patient actually do a library test so every the clinician would think of a question and a situation and we would try to work around it we also worked at that time several diagnostic tests kits were validated now these are being used and i mean i look at things my brother came from germany he paid through his nose for a test in rdpcr and in india it's being done for 450 550 rupees so it in in it's only because of tests that have been developed uh through rigorous testing again we also you know unless and until this effort is combined with other efforts so one single-handed person or a team cannot do all research efforts so uh using the power of data and evidence to wage war on kobit 19 you remember ct scans were a big thing that time and and you know combining ct scores with laboratory ct scores and looking at how patient outcomes were were a big big data study this was driven by icmr and this was done called cough base and we were one of the first few people who actually started putting out our data on cough base we started sharing our samples for studying mutations with the government continuously evaluating response we did several predictor models where clinical responses of patients is there any clinical parameter that we can look at then came the idea of the zero convenience and plasma i remember several clinician friends who actually went through the fear you know the really scary over during the delta wave actually managed to donate i mean they are a group of altruists who i think are beyond compare they actually donated and this is a small event actually appreciating them so they all donated convalescent plasma thinking that this will benefit somebody somewhere so it's a separate story that convolution plasma research actually studied proof that it possibly does not make much of a benefit but at that time we did not know this and research continued to make efforts to improve patient care then came the vaccine so when the vaccine came out of course we even participated in several phase three trials for vaccines but other than that and i must again comment all patient participants healthy volunteer participants who actually come forward for vaccine trials it's not easy imagine those people who came for a vaccine knowing that maybe i will get placebo right so i must really those are the people who must really be appreciated but anyway coming to vaccine trials whether you know healthcare workers have a higher risk should take attack vaccine first the we even during the our healthcare worker rollout of vaccine in january we continue to study so we continue to study and look and course correct throughout the disease that i would like to bring forward is is how research and clinical practice should actually combine work together the questions keep course correcting the answers keep keep informing and that's how things move so this is one of our studies where we studied the safety and immunogenicity of the covet vaccine during the vaccine rollout in healthcare workers we studied this for immediate response to vaccine those one those two and long term response also so we are still continuing to do some t cell studies so this is a nice cohort that we have created which is a group of people and we are studying whether you know there is a good response even in the long term with with boosters and others so this is one of our studies that was published whether healthcare teams are at higher risk this is a real world evaluation and at that time there was no data which what is the vaccine doing and this was you know the chat chatrox recombinant vaccine kobe shield and whether you know what are the adverse events there was a whole you know all the world was going through a lot of a phase of where people were refusing there was a lot of vaccine hesitancy but this kind of papers and publications actually help in reinforcing the belief that the vaccine will be useful and it's not as scary or difficult you know to get the vaccine this is our publication on the response of our teams to the vaccine we even continued so when the older people were vaccinated we continued to evaluate the vaccine response in older people uh we looked then came much microsoft we continued to collect data on real life time you know data on much of my courses so the team kept kept moving and this actually last two years helped us create a very strong research ideation team this includes clinical teams and research teams so research teams have now been integrated immensely into clinical teams and are a part of their regular brainstorming sessions about what next should be done currently we are having around 46 56 studies that are still ongoing this is definitely not a one person job this these photographs are just small representative of the team the teams that are required for research are immense clinical teams and research teams and i must say the youth of india i used to at one time think you know that the young indian graduate is very very callous and casual about things but i was happy to see that i was proven wrong during this covert break this small team that you can see which is listed as the power of youth called the yes sir program this was a young team of interns they could all very well have stayed at home they were 20 21 year olds you know their parents must have been telling them you don't need to go you're not even getting a salary but they all came in very committed manner you can see that big group again cheers to them hats off to them the back end i t team wearing unless and until there is good quality data you cannot analyze anything you cannot interpret anything so the importance of the back end teams which are creating collecting the data and of course the expanded research team which is including our clinical teams and laboratory teams and and the research methodology teams so my learnings from this pandemic and i hope that they reflect yours and that people are awesome you challenge them and they rally to perform so if you you know whether it was a natural challenge or a man-made challenge is another deep aid but if you challenge human beings will rally society's response to research changed in my lifetime from 15 years back of we are indian guinea pigs india is in a very bad state only a big company has come to do research in india to bringing this discussion to everyday newspaper news channels saying that what is vaccine efficacy what is vaccine effectiveness when i heard one of the you know research this research debate on a new start prime time discussion i was like you know this is it research has reached the bedrooms of everybody so let's you know the response changed teams are critical and clinicians and researchers and clinics opd's ipd's and research are two sides of the same kind and the most important bit is data data so many of you may not actually not become researchers but at all points i will urge all clinicians to keep collecting data on their patients so once you have data you will be able to see trends because we are by nature clinicians are investigators we are you know sherlock holmes of the healthcare sector we like to investigate our patients we like to study them we will be able to see trends and help our patients to the best of our ability that is the purpose of research in the last two years do you believe research has changed your practice how do you feel about research and publications do you use vaccines were your the drugs that we just discussed about these research drugs used for you or you know a loved one during research do you want to know a little bit more about research if that's the case any of these questions you said yes to then you've moved towards the light of research and i really wish that you stand and bask in this life and enjoy research enjoy reading research you know when i was a young clinician i used to think you know that i i when i read research much of the paper i cannot understand but doesn't matter you know whatever you can understand understand and the next time you will understand better so please go ahead and continue to read research continue to participate in research and continue to collect data on your clinical patients there are some interesting videos that i would like to recommend for you to see one of them is the modern life of henrietta lacks this is an interesting you know research based well-researched movie oprah winfrey stars in it then there's this documentary which is first in human clinical trials there was a complication you must see this trial this and then there's forgetting i forget i can't see full name of it but i'm sure if it can be this is ah forgetting dr mengele this is from the holocaust so these are research based movies which actually are well researched so they actually present to you a real phase of research do have a look at these videos these are some suggested readings in case you're a reader and not a person who likes to see some videos and that's i don't even have a thank you thank you so much thank you so much for joining us today in case you have any questions i'd be happy to take them thank you mama for an amazing presentation uh went through all the stages very well explained and i think it was really nice that you took a live example that we just went through the pandemic so it really helped out there um so everyone who's there in the audience i can put your questions in the comment section you can type it out there or you can also use the raise hand feature and we'll accept you on stage and you can come here and ask them your questions directly um okay so there's a question from jayesh who says how to be access patient data for research purpose if you're not working in a hospital or a clinic setting ethically you must you know actually look at your own patient data do not look at somebody else's patient data because you know finally the patient's data is owned by the patient and indirectly is given that access to this clinician and there's a consent acceptance you cannot use anybody else's patient data if it's your patient you can use the patient's data which comes from opd which comes from when they're admitted you can even conduct surveys goals for them you can today's world people are collecting data through variables so if you're you know you're having a diabetes practice and you want to look at patient's response to exercise you want to see if he's lost weight on xyz drug whatever drug you started you want to see so whatever you want to see can be documented so there your people are doing variables now that can be used for data collection of course you have clinical you know records if you have uh even in small hospitals nursing homes now people are using digital records electronic records is the need of the hour and it will definitely be coming in india soon and we've realized that india adapts very fast in case of an emergency or in case it's made mandatory by the government so if in case it's made mandatory if you will have to have it sure medical college you may do research in one's own specialty of course you can continue but you need consent of the patient and you will need irb and ethics committees of google also for institutional reviews is asking about flashing some light on translational resources so translational research studies are there are several institutions there is one of which is translation the technology institute which does some excellent work in translational medicine but translation today is as i was talking to the team here is all about innovative translation so earlier translation used to take the regular regulatory process of eight years ten years nine years phase two phase three phase four trials but now innovation and innovative healthcare techniques have actually caused this translation to happen in a much faster way right there are newer dressing materials available newer diagnostics available at a much faster rate and that's what translational research is all about there are several incubation hubs now that have come up whether these are public incubation hubs or private incubation hubs there are hubs around new medical technology that have come up in india there are groups that are setting up to accelerate this so as you know one of the groups that i am working with is pristine health care and they are they're actually looking at creating they have a network of almost 400 hospitals all over the country you know use leverage this network to validate a lot more and can be done by a single hospital so there is today's world is all about looking at how quickly technology can be bought how quickly it can be used and what is the maximum benefit patients can come you know make use from is there any online forum for youtube ah this is a very interesting one so seems like jersey is writing for the icmr sts grant and he's wanting some so there is definitely definitely there are several grant opportunities for young young researchers now and there are youth grants available whereas i can tell you that there's icmr is giving you grants dpt dst is giving you grants there are if you put youth grants there are translational indo-us grants exchange you know for opportunity of learning there is sn bose grant is available for youngster research there is an indo-australia exchange program that is available so there is a lot of opportunity now for young doctors to actually they can get guidance i i don't know whether they can really get guidance but definitely my my company will try to hear and answer this question from the doctor [Music] is there any other question that i have missed have i missed any question thank you for answering the presentation of statistical analysis for data used in research i am sure i can do if the team but i can't do it today the statistical analysis calls me on another day we talk about statistics sure but the important thing about statistics is basically three things it needs to be generalizable you have to remember that there are several confounders so anything that you see may not really be the truth so you have to use your clinical judgment you have to use biological judgment and common sense before you actually understand statistics statistics is not just statistical tests it's a lot of common sense so we talk about okay there's somebody talking about non-superiority trials is it okay what what does doctor always want to know about non-superiority trials can i put it forward here now yes yes yes yes yes so the question was ma'am how can we speak to the patients or convince the patients to participate more willingly in these clinical trials from a patient perspective thank you that was very very important what happens is clinicians tend to speak from this level to patient patient is at this level it's a natural thing that it's sort of trained on i don't know how where in clinical risk practice it's a very you know it's still acceptable because patient is in need patient is looking forward it's easy but in clinical research he's not in tonight several times he feels you are in need so he will definitely hold that but i have realized that if you tell patients very clearly they actually understand so i've worked with patient support groups in cancers so we work with pediatric cancers to a group called kids i work with diabetic patients and these are young children with type 1 diabetes they actually want to participate in research they want to have better treatments so they are very happy to participate but the explanation must be given in a lay person language and a lay person language is very difficult thing for doctors to do right so lay person communication is something that we all must learn and all our so i've been trying to now of course [Music] language as well in addition uh i think you know my experience healthy country trials these are people who do not have the disease so if you're looking at a cancer patient or a diabetic patient wants to know what is a solution so he may practice it but what about healthy one of those how do they come about so i make it a point to actually ask all my healthy volunteers why have you come to participate in this vaccine trap many of them will say it's because of you know money that's there it helps me i would want to want to know my friends have come so i've come but there are some of actually that you know we don't participate this problem will come up and you know i myself it has taken me i think in the first i have i have been a clinician researcher for five years after i then i participated in my first trial so i have participated in clinical trials but after several years of being a clinician and a researcher but patients come forward to participate healthy volunteers come forward to participate there was this one young gender gentleman i remember he volunteered his child for a rotovirus vaccine so why did you do this you know you were allowing first child he said you know madam i am a farmer pharmacist i know the drug development process if i do not participate if my child does not participate children will continue to die of diarrhea so people are altruistic to the pe you realize that when you go through this process that if you appreciate them they actually come forward so consider them as your partners in research explain things clearly to them [Music] does that answer your question yes yes [Music] it's um okay so she's asking whether you know there is superiority inferiority and non-inferiority so when when you're looking at a superiority trial you want to prove your new treatment is better when you want there is nothing really not many people will do an inferiority trial [Music] but the non-inferiority trial says it's as good as so very few actually studies we do a trial to prove a drug as good as because there is a high cost of running a clinical trial right that is why they would not want to have as good as trial when you do it as good as that means it is a non-inferiority trial the sample size is big right and you will manage because the difference between the two drugs or the two treatments is so small you will actually end up with a big sample size and and therefore the cost of the you know trial will be so much higher so the very few people want to fund it they would rather say it is a superiority trial the same trial they will present as a superiority trial and have a smaller sample size they are saying that it is better than and in case they are not able to prove it is better than then they will let it go the drug will not come to market but to say as good as is not something that makes no clinical sense or even no sense to bring a new drug which is only as good as she's saying wise [Music] any tips for students post graduate and pharmacology and developing correct orientation like making good papers or publishing the best tip for any student whether it is for pharmacology or other is please start reading papers unless and until you read a paper and you learn how to critique paper you remember that you have journal clubs and beyond you know pretty much sleep through them but really use those journal class those journal clubs are very useful if you read one journal or two journals you know articles a week you will learn how to automatically it's not even you don't even have to make an effort you just keep reading and the terms will become clear you don't have to read statistics you just keep reading a paper so choose two papers of the area that you like and just keep reading you don't need a teacher you don't need a mentor you are at a position where you can do it yourself if you can create a peer group that is even better so if you have two or three peer group people who are interested in in similar research let's discuss it among themselves give it 10 minutes read it yourself give it 10 minutes discuss it at your own level you will learn so much better so that will help you that will also help you define which is the journal you should publish in you know what is the kind of paper publishing type of research acceptable and so once you started reading second step you start writing so right because we have a picture we feel i can't write as well i am not such a good communicator the other fellow is writing such such good english i don't know how to write that english all right start writing get rejected the beauty of research is that you will have several rejections before you are selected so keep on keep on writing keep on writing and now there are so many journals you know you may not get into a you know pubmed index journal in the first group but you will get into some other journal i was purpose there are some free journals now you have made archives you have you know archives which are publishing free so this is no cost to do the publication so you put in mad artist at least somebody will critique your writing and send it back to you right so first step read read read and read second step is start writing whether you write for free journals whether you write for your own institutional journal but start writing get rid of that fear of writing and then i'm sure you will reach whatever target you want to reach are taking it taking it off of writing uh what would you look for like when you actually want to publish in a journal like you said like don't look at the journal what you want to publish and just start writing but if you go to that level when you're really writing that well so what are the points that you would look for before selecting a journal to publish your article so you know it is a question of what you want to write now we did this very interesting study for antibiotic stewardship and we had we worked with johns hopkins it's called the comprehensive unit-based safety protocol so they made the doctors the physicians the pharmacist the microbiologist responsible for antibiotic stewardship through certain techniques now this is something we wanted to publish now whether we should publish it in a microbiology journal whether we could publish it in a pharmacology journal we could publish in the critical care journal we could where where would it make most impact so when we looked at our own data we realized that where was the most difficult group of people who actually was not accepting antibiotic stewardship and we realized that that group of people was the hospital administration so we actually chose to publish in the hospital administration journal and this is not not just our hospital we realized that it was coming internationally that the hospital administration is the most resistant parameter for antibiotic stewardship because it requires it's a resource heavy activity so sometimes they think it's not necessary so we publish we decided to publish so you have to decide what is the reason why you want to publish what is your target population start from there thank you we have dr made this guy who's asked a drug uh which is non-inferior but safer would surely be preferred for non-inferiority trials yeah it's a common sam i think everybody like when you started you said you were in obg and then you shifted into clinical trials so if somebody wants to make that switch in their career how would you start making that switch so you know we were asking about whether uh clinicians who want to make the transition into researchers i think there is it's a natural tendency there are some people who are who like being a clinician researcher these you can see them when we do our dnb training program i see so many students everybody has to forcibly present a thesis but there are some who will do their thesis with such diligence [Music] so there is each one is different right so you could be just a clinician you could be a clinician researcher just find that about yourself and continue to do some research continue to read and write it will improve your clinical practice immensely right it will be it's a it's a habit that you know as you develop several other good habits please develop this habit of reading and writing and automatically publication will come and if in case somebody wants to make a career transition into research that is something that the pharma industry is always looking for please feel free there's of course also patient support groups there's also non-profit organizations that are looking for clinician researchers uh there are the blade bill and willing to get foundations the path and several ngw's looking find what your focus is what is your interest what interests you it took me 20 years to identify which way i wanted to go each i mean i'm i'm hoping some people are smarter than me this will not take 20 years yes ma'am i think this session was a very good initiation in that direction i think uh people will at least start reading a lot of articles start writing small steps and then make the transition uh slowly uh i think we've covered all the questions you keep your eyes open when you're seeing the patient question yeah um so since i don't see any more questions coming in i think we can um close the session for tonight and i will surely uh get back uh to um with the second session on statistics and we'll plan that soon for maybe june if you are available we'll definitely get that done and thank you so much for coming on netflix i hope you enjoyed it and um everybody thank you so much was really nice and everyone here and i hope some of the young doctors are inspired to read write and become researchers or at least appreciate researchers and patients who participate in research yeah and everyone here thank you so much for joining us tonight um and thank you so much once again thank you ma'am and goodnight everyone [Music]

BEING ATTENDED BY

Dr. Ragini gautam Rahangdale & 794 others

SPEAKERS

dr. Pooja Sharma

Dr. Pooja Sharma

CEO, APAR Health | Principal Consultant at Prystin Research Innovation & Medical Excellence Unit | Senior Scientist & Advisor, Medanta Institute of Education and Research, Gurugram

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dr. Pooja Sharma

Dr. Pooja Sharma

CEO, APAR Health | Principal Consultant at Pr...

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