Clinical trials, that hot-button subject hogging headlines up until a year ago, appears to have quietly slipped into the realm of business-as-usual. However, there are still some knotty issues to be resolved. Chief among them is the oversight of Ethics Committees (ECs) as was evident at a recent event I attended.
ECs – which are a mix of experts and lay persons – are the gatekeepers of ethics within their institutions. Just as a strong EC can blow the whistle on unethical behaviour, a weak or careless one might inadvertently abet it. Continue reading
The holiday season approaches, so here’s a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It’s a mixed bag (what year isn’t?) including stuff that could influence the way things work in the years ahead. For convenience, I’ve divided up what I think are key developments into posts rather than stick to any specific chronology of events. The first post was on the regulation of Indian manufacturing. In this second post, I look at developments in the regulation of clinical trials. Continue reading
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.
A recent meeting that Apothecurry had with clinical research industry executives in Mumbai suggests that the sector intends making a strong push to salvage its tattered image. Faced as it is by an unprecedented crisis of confidence, that’s not terribly surprising . However, much of this effort’s success will depend on the regulatory reform that the industry can force in the coming months and years. Continue reading