Are international clinical trials regulated? By the FDA? By anyone? In gentle language, the U.S. Department of Human Services says that one of its own fiefdoms, the FDA, has been unable to keep up with the rapid growth in clinical research outside America. The push to find clinical trial patients outside the U.S. is not news. But…more...

Not long ago, the Drug Information Association (DIA) and FDA’s two most important divisions, CDER and CBER, held a joint meeting. Its title was less than intuitive: “Computational Science Annual Meeting.” But the goal of the meeting was laudable and significant to everyone in clinical research. The idea was to explore how technology, broadly defined, could help…more...

What do life science companies produce? Medicine? Pacemakers? In truth, those items are often manufactured by anonymous subcontractors. What life science companies really do generate is intellectual property. Data. Content. Satish Tadikonda, the founder, president and CEO of Virtify, says that the content in our regulated industry will increasingly be required to adhere to a variety of…more...

Wondering what the FDA's special protocol assessments (SPAs) are all about, but too afraid to ask? Last year's Drug Information Association's (DIA) 45th annual meeting was especially helpful, as representatives of Bristol-Myers Squibb, GlaxoSmithKline (GSK) and the FDA's Office of New Drugs within the Center for Drug Evaluation and Research (CDER) presented on the topic. An SPA,…more...

Given that clinical trials are conducted globally, couldn't they be regulated in the same manner? That's what the FDA and the European Medicines Agency (EMEA) will explore this fall. The two agencies have just announced they will collaborate for 18 months on a new bilateral good clinical practices (GCP) pilot project. Leslie Ball, director of the Division…more...

Contract research organizations (CROs) will now have to register with the body that regulates clinical research in India if they want to continue partaking of the boom there. India's Central Drug Standard Control Organisation (CDSCO) has issued Rule 122 DAB on “Registration of clinical research organisations for conducting clinical trials.” After its 45-day comment period, the rule…more...

The regulatory system in India is maturing quickly. Just a few years ago, it was said to be in its infancy—with drug makers and contract research organizations (CROs) largely having to regulate themselves. Now it is an adolescent, and growing up fast. To explain where India's been and where it's going with respect to regulating clinical trials,…more...

More trials. Bigger trials. More technology and services firms supporting each trial. More types of data. More silos. More entrenched egos defending the silos. All of the above should be driving the adoption of the approach of the Clinical Data Interchange Standards Consortium (CDISC). But pockets of resistance to standards remain. Outside a tight group of CDISC…more...