Why did India remove cap on number of #clinicaltrials per investigator?

The central government, through the office of the Indian drugs regulator, has done away with the cap on the number of clinical trials per investigator. This is after it was pointed out by clinical research stakeholders such as sponsors and investigators, that this could lead to under-utilisation of clinical trials infrastructure, and investigator expertise.

The decision is now left to the Ethics Committe (EC) of the institution where the trial is to be conducted as was recommended by the Expert Committee set up by the government under the late Ranjit Roy Chaudhury. This is clearly a great relief to those involved in the conduct of clinical trials.

But at the risk of sounding like a wet blanket, I have to say – this sounds suspiciously like one of those on-again, off-again decisions that pretty much leave you where you started off with, wondering what really was achieved.

The cap on clinical trials was fixed, along with a number of other rules, when the drug regulatory apparatus was entirely on the backfoot defending itself against a public interest litigation in the Supreme Court.

From what I could make of it, this specific rule was in response to the criticism that investigators are taking on more trials than they can handle for reasons such as stature, funding etc putting subject safety at risk given the very limited number of investigators equipped/skilled to do trials in the first place.

Now the government did what it does best – fix an arbitrary ceiling. “No more than three per investigator,” it said wagging its finger.

Sponsors and investigators, of course, were upset, to say the least. They reasoned. The number of subjects per trial is not fixed, they pointed out. A cardiovascular drug trial is far larger than one for cancer treatment or a rare disease. So an investigator may have 150 subjects across three trials or just 15. The latter might be able to take on more trials. Why should they be made to sit around twiddling their thumbs when they have the bandwidth to do more?

So after much reasoning, the government has yielded. But the responsibility of deciding how much an investigator should take on now rests on the EC of the institution, much like almost everything else to do with the trial.

But wait a minute, a good EC would have always asked the PI, “Aren’t you taking on too much?” It’s common sense, I would think.

So why was a cap felt needed then, and why is the issue back with the ECs now? In other words, what changed? I don’t know. It is not as if the last two years saw a raft of accredited ECs on whom the CDSCO can rely with any more confidence than it did before. Read my earlier post on that here. Now, if the cap had been levied on the number of subjects under an investigator’s care across trials that still might have sounded more like a mid-way solution than this.

What I do know, is that too many decisions are being taken and revoked inexplicably. In fact, don’t sue me but I am tempted to draw parallels between this and the pioglitazone ban. Banned one month, back in two with no data or anything to support either decision.

What are we up to here?

Pic sourced from Google Images


One thought on “Why did India remove cap on number of #clinicaltrials per investigator?

  1. Ms. Gauri – very interesting perspective on the recent Circular. I think you would agree that the end of the day, the primary objective of the local clinical trial industry and government is to bring back the glory days of clinical trials in India. Not sure whether changes such as this will allow this objective to be achieved as significant damage has been done since 2012 with applications relying on Indian trials jeopardized. Of course, no one can argue (irrespective of whether it was a gut reaction, finger pointing or any other motive) that Investigators need to be qualified and have the necessary resources to carry on trials. Yes, the number of trials was arbitrary, but unless the government outlines objective factors in determining how many trials should be carried on by the gov’t, not much will change with the insertion of the Ethics Committee making this determination. Also, not sure whether limiting or capping patient size would work as the duties of the investigator can be the same for a 500 patient or 100 patient trial depending on the drug, number of adverse events, etc. In addition, a cap on patients would also arbitrarily eliminate certain types of trials that require larger patient size.

    Liked by 1 person

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