Tag Archives: clinical research

Enough said, it’s time to act : my article in PICR

24 Jan

Late last year, I submitted an article to the journal Perspectives in Clinical Research (PICR), brought out by the Indian Society for Clinical Research (ISCR). This issue of PICR is titled “Ethics in Clinical Research” with contributions from bioethicians, patient advocates, trial sponsors and investigators, among others. The publishers informed me yesterday that the issue is out.  Here’s a link to the article.


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The media and clinical trials

8 Oct

WatchdogThe Drug Information Association (DIA) recently had a webinar with international participants on the ethical issues arising around clinical trials in individuals with reduced autonomy (like children, very sick people incapable of taking decisions, the mentally ill, prisoners etc).

One of the subjects discussed was the media’s role in clinical trials. One participant wanted to know if national media in India feel a responsibility to educate the public about clinical research in general, in addition to reporting when things go wrong. I don’t know for sure but I suspect this question stems from a feeling in some quarters that media gives too much play to botched or allegedly botched trials. But does little to help the cause of ethically-conducted trials that bring drugs and other medical interventions to market.

Here are my thoughts.

The media have viewed themselves primarily as watchdogs given the acceleration of clinical trials done in India, and it’s emergence as a business opportunity in the absence of sufficient regulatory oversight and action.  The Indian government’s abysmal spends on both healthcare financing, and infrastructure-building means that there could be many who will participate in trials only for free treatment without completely understanding what they imply. That is very conceivable though the degree to which this happens may not be known.
While the DCGI’s office has taken some positive steps like making the registration of clinical trials on ctri.in compulsory it still has a long way to go on subjects like trial audits, and oversight of ethics committees. Importantly, it is not transparent about outcomes of regulatory action, a must-do if it has to inspire faith in its ability to regulate.
There also haven’t been enough champions for trials outside the CRO and drug industry. This is important if the media have to view clinical trials as an activity that could lead to social good.
Finally, I am not sure whether there is enough being done to engage the local language media which has a wide-ranging influence on opinions and perceptions on the subject.  GCP in Hindi, Tamil,  or Marathi anyone?
 
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