Do You Want to Make COVID-19 Drug ? | UPSC
Why is there a stress on randomised controlled trials?
WHY IN NEWS:
What due process must be followed in the appraisal of any drug, especially those for COVID-19?
SYLLABUS COVERED: GS 3:Drugs : CDSCO
For PRELIMS it is important to understand why RCT , The relevant acts and most important process of registration.
For MAINS Consider yourself doing a research on drug . List down all the necessary criteria you need to meet to qualify your drug under CTRI (Clinical Trials Registry of India ) .
Ramdev, the yoga guru, and who is associated with the company, claimed that a randomised controlled trial (RCT) among COVID-19 positive patients had proved favourable results.
- Ministry of AYUSH responding a short while later, told the company to stop advertising the drug as a cure for COVID-19, pointing out that it would attract provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
WHAT HAS THE GOVERNMENT SAID?
- RESEARCH DETAILS : The Ministry said the details of the study were not known to it and it has asked Patanjali details of the name and composition of the medicines .
- VENUE AND SAMPLE SIZE : Site(s)/hospital(s), where the research study was conducted for COVID-19; protocol, sample size, Institutional Ethics Committee clearance.
- REGISTRATION : CTRI registration and results data of the study (ies) .
- LICENSING : The Ministry has also “requested the State Licensing Authority of the Uttarakhand government to provide copies of the licence and product approval details of the Ayurvedic medicines being claimed for the treatment of COVID-19”.
- The clinical trial tested the drug on 45 people and another 50 were given a placebo.
- The claim was that 69% (31 persons) of those on the drug tested negative on the third day, and 25 of those on the placebo arm of the trial had also tested negative.
RCTS ROLE IN CLINICAL TRIALS?
- RANDOMISED CONTROLLED TRIAL : RCT is a study in which people are allocated at random, entirely by chance, to receive one of several clinical interventions.
- CONTROL STEP : The control may be standard practice/treatment options, a placebo (a drug without an active substance, or a ‘sugar pill’), or no intervention at all.
- OBJECTIVE : The idea is to measure and compare the outcomes against the control after the participants receive the treatment.
- SINGLE-BLIND TRIALS : The participants, or the investigators do not know who is assigned what.
- DOUBLE-BLIND TRIALS : Both participants and investigators do not know.
- TRIPLE AND QUADRUPLE-BLIND TRIALS : Where three or four of the relevant groups are not aware of the treatment assignment.
WHY DO WE NEED RCTS?
- CHECKS AND BALANCES : No other design can get us close to the ‘counterfactual’ comparison we need to see if an intervention is causally linked to a particular outcome.
A GOOD RCT FOR COVID-19 INCLUDES
- Enrol enough numbers
- Defined clinical endpoints
- Including mortality and morbidity
- Days of stay in hospital.
HOW CAN YOU CONCLUDE WITH RCT
- We get the best evidence from an RCT.
- Follow the groups over days, weeks, years and observe major clinical end points.
- RCTs remove the impact of chance in cause and effect relationships.
- It is possible for you to estimate if there were any differences between the two groups.
WHAT IS THE FUTURE?
- Strident science should be the basis of any interventions in therapeutics or vaccinology.
- The over 200 projects in the pipeline, listed in the Clinical Trials Registry of India, might produce results over time.
- This means, clear and robust evidence about benefits and risks.
SOURCES:THE HINDU | Do You Want to Make COVID-19 Drug ? | UPSC