My Brief Journey with Medical Research

My Brief Journey with Medical Research

I have been wanting to write about this for a very long time, but have been postponing it, like most important stuff in my life outside the hospital. But a recent conversation made me sit down and finally complete this.

I recently took a short leave and was driving with my Dad to get some bouquets for a function at home. Being not so expert at driving, travelling with Dad can be a little daunting because he would not wait a second before scolding me for a mistake I made. Not so smooth a clutch release, a delayed gear change, taking a wider turn than required—you name it.

Nonetheless, I enjoy these rides and look forward to them during every short leave I get.

During this drive, we somehow reached the topic of medical research. I started explaining the different types of research and the different ways it can be conducted.

“Basic research, clinical research, observational studies, interventional studies… and then there are different ways of sponsoring clinical research.”

“There are different ways clinical research can be sponsored. Broadly, studies may be investigator-initiated or industry-sponsored. Investigator-initiated studies are those initiated by clinicians or other researchers, often in academic institutions. Like the kind of research Vanita Ma’am and Kumar Sir do at Tata Memorial. In India, many investigator-initiated studies involve existing drugs—for example, studying repurposing, different doses, combinations or indications—although investigator-initiated trials can also involve investigational drugs. Industry-sponsored studies are often part of the development of newer drugs, although they can also involve already approved treatments.”

My Dad swiftly made a comment:

“Yeah, like the ones they do on dogs and guinea pigs.”

I replied, “Yes, but we can’t just start giving humans drugs that have only been tested in animals. They have to go step by step before they can eventually reach the pharmacy.”

I went on to explain the different stages of drug development and clinical research. The conversation went on, but it was clear that my father, like many others in Kerala and elsewhere, had some fairly strong opinions about medical research, and many of them were negative.

This brought back another flashback.

To my first year of MBBS at AIIMS Bhopal.

We had CFM—Community and Family Medicine—or PSM, as it is called in many other medical colleges—from the first year onwards. In the first year, when we were absolutely new to research, we were given the task of coming up with topics for research. Our batch was divided into a few small groups.

Every group came up with different ideas. I don’t remember most of them, except for one about “bitter gourd to cure diabetes” and my group’s topic.

Our group had decided on the topic:

“Illegal drug studies on Indians.”

Our PSM consultant, Dr Chaudhary, thought about it for a while and said, “Yes, great topic. Come back with some initial work.”

So our “RESEARCH” started.

For most of us in the group, research meant studying a topic in depth. We would go through many sources, make a summary, become experts on the topic, and voilà, we had researched a topic.

And we went to our most trusted source available.

Newspaper cuttings!!

But it wasn’t easy because we were in a new city and didn’t have our old newspaper piles with us like we did at home. And Jio wasn’t there yet. Still, we managed to go to an internet café and get a few printouts of news articles.

So we went back to our consultant with our decent, if not well-RESEARCHED, paper.

He made us sit down and started explaining things to us step by step.

First of all, what we did would not have been considered original research. At best, it would probably have been closer to a literature review or a review of existing reports.

Then came the proper blow.

We were very vocal about the things we had found—research being conducted on Indians with new drugs, and how these drugs had caused side effects in many people.

A few things Sir told us shook some of our rather naive beliefs at the time.

The first was:

Not everything in the news is necessarily true.

I was literally shocked.

But then, thinking about it, I had actually wondered about newspapers even as a child. How did they know something had happened so quickly, verify it correctly and publish it the very next morning?!

Then came the second line:

Not all drug research is illegal.

There can be well-designed, scientifically conducted and properly approved clinical trials involving investigational drugs.

I was shocked again.

“How can it be? We are humans. We are not some lab rats. How can there be an approved trial?”

Sir saw our shocked faces. But instead of clearing the confusion immediately, he asked us:

“How do you think a new drug is found and researched?”

We actually didn’t have an answer.

So he sat with us and explained the different stages of drug development.

Preclinical research involves laboratory and, where appropriate, animal studies to understand a drug’s pharmacology and potential toxicity before it is given to humans.

Phase I is the first stage of testing in humans and primarily assesses safety, tolerability, pharmacokinetics, and appropriate dosing. These studies are often conducted in healthy volunteers, although in areas such as oncology, Phase I studies commonly involve patients with cancer.

Phase II involves patients with the disease and aims to obtain preliminary evidence of efficacy while continuing to assess safety.

Phase III involves larger studies designed to provide more definitive evidence of efficacy and safety, often by comparing the treatment with an established standard treatment or, where appropriate, placebo.

And then comes Phase IV, after regulatory approval, involving post-marketing studies and surveillance to understand the treatment’s longer-term safety, uncommon adverse effects and performance in broader populations.

He also explained how the system had evolved over time, with regulations, scientific guidelines, ethics committees and other safeguards designed to protect people participating in research.

And yes, the topic we had chosen wasn’t completely irrelevant either. Unethical or illegally conducted research has occurred historically and remains a concern wherever research regulations and ethical safeguards are violated. Those practices need to be identified and stopped.

Coming back to the present, I explained all of this, including this story, to my Dad.

He seemed to understand it a little better, although he still had his doubts about the profits pharmaceutical companies make and the various other issues surrounding the industry.

By then, we had reached home.

So, we kept the rest of the discussion for another drive.

I went back to checking my still-unfinished data entry and manuscript writing based on real-world data from patients at Tata Memorial Centre.

Tiring work.

Sometimes frustrating work.

But still, important work—contributing, in our own tiny ways, to the larger body of medical knowledge.

And I had another thought about the evolution of research.

Research has made mistakes.

Some of them could have been avoided. Some probably could not have been, given the knowledge and systems available at the time. And even the process by which we conduct good research has itself required research, criticism and continuous improvement.

Science, in many ways, has learned to correct itself.

Researchers question each other. Studies are peer reviewed. Results are replicated or challenged. Errors are identified. Methods improve. Regulations evolve. And sometimes, ideas that once seemed perfectly reasonable are shown to be wrong.

Perhaps that is what struck me most about the conversation with my Dad.

Just as he sits beside me and immediately points out my mistakes while I am driving, research has its own ways of pointing out where we have gone wrong.

The difference is that science takes a little longer to change gears.

But hopefully, it keeps moving in the right direction.