New drugs, new vaccines require new safeguards
Clinical trials are necessary. They are aimed at benefiting patients, improving treatments and introducing better and more effective drugs and vaccines to help combat diseases. Therapies, surgeries, and highly life threatening treatments are also clinically tested first on volunteers. These volunteers are registered and if the procedure goes wrong compensation is given, either to them or their kin.
Clinical trials process summary| Phase | Primary goal | Dose | Number of participants | Notes |
|---|
| Preclinical | Testing of Drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information | Unrestricted | Not applicable (in vitro and vivo only) | - |
| Phase 0 | Pharmacokinetics particularly oral bioavailability and half-life of the drug | Very small, subtherapeutic | 10 people | Often skipped for phase I |
| Phase I | Testing of drugs on healthy volunteers for dose-ranging | Often subtherapeutic, but with ascending doses | 20-100 | Determines whether drug is safe to check for efficacy |
| Phase II | Testing of drug on patients to access efficacy and safety | Therapeutic dose | 100-300 | Determines whether drug can have any efficacy with no presumptions of therapeutic effects |
| Phase III | Testing of drug on patients to access efficacy, effectiveness and safety | Therapeutic dose | 1000-2000 | Determines a drug’s therapeutic effect with presumptions of some effect |
| Phase IV | Postmarketing surveillance or watching drug use in public | Therapeutic dose | People seeking treatment from their physician | Watch for drug’s long term effects |
Many have questioned the ethnicity of clinical trials and accused it to be devaluing the lives of poor who usually sign up for the process without knowing what it is about. Should stringent measure be taken to follow safeguards while dealing with clinical trials or should they be allowed to continue unhampered?
For1. Poor and uneducated are exploited: The volunteers of clinical trials are usually the poor and uneducated who have no idea what they are signing up for. All they care about is that they will get some cash out of it and if anything goes wrong, their kin will get compensation. There have been numerous instances where people complain of being left in the dark about the procedure and the risks associated with it.
2. Setback: On March 2016 Health Ministry amended the Drug and Cosmetic Act, exempting clinical trials conducted at academic institutions from taking the till then mandatory permission from the Drug Controller General of India. This is a huge setback when it comes to ensuring safety of clinical trials. On one side we are aiming at creating a transparent system for it and on the other we are easing on the rules. Research and innovation should not be caught in red tape.
3. Dangerous expeditions: Rules and regulations are being eased out without considering the 2013 incident when at least 370 deaths were attributed to Serious Adverse Events (SEAs). There are instances of children vaccines testing going wrong and yet no stringent measures were taken to ensure that such instances could be reduced. Drugs and research are meant to save lives and not endanger them while treating people as expendable assets.
4. Waiving phase III trials: If a drug is approved in US, Europe, Australia, Canada or Japan, then phase III trials are to be waived off according to government’s latest take on norms of clinical trials. This is also a setback since directly proceeding to phase IV of marketing might have adverse effects if the drug doesn’t go well with the people of our region depending on their diet and environment.
Against1. New guidelines: Government is doing all that it could to prevent the poor and uneducated from being exploited in the procedure. It is compulsory for the institute or the organization carrying out the trails to make the volunteers and their kin aware of the procedure and associated risks. Their consent is taken on the whole matter before initiating the trial.
2. Ayurvedic medicines too require safeguard: Earlier Ayurvedic medicines were deemed safe and tests and trials were not required but now it is compulsory for them to carry out clinical trials of the products. It is a known fact that herbal and ayurvedic medicines are safe enough and doesn’t harm if not benefit.
3. Delays the process: Research and innovation are for the higher good of the society. There are numerous new drugs and vaccines that can speed the process of treatment but we lag behind in clinical trials and hence when an epidemic like dengue breaks out, it takes forever for our doctors and medical association to come to meet the challenge in large scale. Had clinical trials not been so strictly mandated and delayed from time to time, our medical facilities wouldn’t be lagging behind to this extent.
4. Depriving India of latest drugs: The drugs that have been developed, tested and marketed in countries where the regulatory system is known to be robust are already safe for use. Wasting time and fund on further testing the same drugs is an unnecessary delay. So many people could benefit from the drug in the duration which it takes for the drugs to be tested.
Clinical trials are meant to save lives and not put them to risk of serious ailments. Government should not impede upon research and trials as they are absolutely necessary but at the same time better safeguarding norms need to be developed instead of easing out the old ones.
