Iam a medical researcher which means I do clinical trials for a living. Product owners ie pharma companies have mandates from the GoI to conduct independent third party verification of the safety and efficacy of their product they granting permission for marketing. Enter CRO – clinical research organisations like ours.
Answering oft asked and oft thought of questions
1. Are clinical trials akin to treating humans like lab rats? Similar to planet of the apes?
No, all that is bogus. There are no eldritch stories to share. It’s boringly regulated and strict. We have consent forms and strict regulations on what and can’t be done.
2. Do all drugs undergo testing?
Some do, some don’t – there are multitude of factors that determine the tests undertaken before a product can reach the market.
3. What products undergo testing?
Anything with a label claim. The paracetamol that claims to alleviate headache, that shampoo to reduce hairfall, the collagen aimed at improving skin health – if it has a claim, clinical trials are what validate the same.
4. Does everyone with a label claim undertake clinical trials?
Sadly no. Across the world, allopathic drugs, vaccines, devices are highly regulatory ie lot of red tape, rules and guidelines to follow for a clinical trial to be able to get a marketing license. But products like FMCG, cosmetics, nutritional supplements, AYUSH products are not regulated yet. The public for some unfathomable reason considers “natural” products safe and allopathic products to have “side effects” when 90% of anything “natural” etc isn’t even clinically validated before they reach the shelves!
5. Is this an interesting field?
Extremely. Governments across the globe give you perplexing guidelines, clients give you small budgets and disproportionate ambitions that teach you the nimble art of navigating tapes of all Colors. Your learn a lot everyday. Every trial design is a new experience and it’s it beyond satisfying to see a product that I have worked on with the CTRI number on the shelves in a pharmacy or grocery store!
6. Do we force/coerce/induce people to participate in trial?
No! Informed consent documents are many pages long, approved by an Ethics Committee and we get a minimum of 8 signatures from the participant before we can even measure their height. Also they can withdraw anytime without repercussions.
7. Can a product be 100% effective? Can 100% of participants show positive results?
100% no. If you see 100% in the study results, know that the results are 100% fake. It is impossible for all participants in a study to show positive effect. All your friends don’t like the same movie to the same extent – similarly drugs show different levels of effectiveness in different people depending on a multiple of factors from their medical history to weight to diet to even stress levels. The average of such a diverse data would never be 100% No drug is ever going to be 100% effective. Simple things like food, sleep and exercise interfere with blood work skewing resulrs. 100% is wrong! That’s just fake data and fake data is very easy to do.
I told you the field is interesting, I told you iam very ethical about my work. And that’s all iam telling you.
8. How did I get into this line of work?
Did a quick course to change paths cuz I majored in biotechnology which has zero scope in India.
9. What’s a typically work day like?
80% on the laptop working on documents. 10% client calls. 10% site Coordination.
10. What’s the best and worst aspect of this job?
I love knowing about so many product before the general public. I love working on documents so preparing a 400 page report solo gives me a high like no other. The downside of I have to call it that is the confidentiality aspect. I can’t discuss my job – no with family, no even with prospective clients. A bit of a bummer that one. Oh and the amount of paper! This industry is on the opposite end of being eco friendly – the reason I went paperless in 2019 for my personal journalling and everyday lists.
