Pharma bodies come out with disclosure code for clinical trials

Even as drug regulators the world over are becoming more stringent in scrutinising clinical trials, associations of large pharmaceutical companies in the United States, Europe and Japan have come out with a uniform disclosure code for the clinical trials sponsored by them.

The disclosed information will include a short description of the clinical trials in layman’s terminology, its phase, its purpose, condition of disease, location of trial and contact details of the investigators.

The data of all such trials, irrespective of where they take place, will be made available online within a specified time frame. The companies will carry out these disclosures even if a country’s regulations do not mandate such disclosures.

The joint decision of the European Federation of Pharmaceutical Industries and Associations, International Federation of Pharmaceutical Manufacturers and Associations, Japanese Pharmaceutical Manufacturers Association, and Pharmaceutical Research and Manufacturers of America has much significance to India as the country is being projected as one of the future destinations of global clinical trials.

Since 2003, India has sanctioned over 600 global clinical trials to be conducted in the country. All of them are in various stages of trials today.

Transparency in clinical trials is expected to improve the image of pharmaceutical companies that are sometimes blamed for alleged “unethical” practices in the trials.

The new disclosure code says that members of these associations should make the details of clinical trials they initiate within 21 days of patient recruitment. The details can be made public through any of the online clinical trial registries that are free and publicly accessible regardless of where the trial is conducted.