PhRMA revises principles to increase transparency

Following calls for increased transparency PhRMA has published its new clinical trial principles, which contain revisions relating to registration, authors and sponsor disclosure.

The pharma industry has been under increasing pressure to become more transparent, with issues such as payments to physicians conducting clinical trials and ghostwriting gaining prominence.

In response the Pharmaceutical Research and Manufacturers of America (PhRMA) has revised its guidelines, which it claims reinforces its “commitment to patients and healthcare professionals”.

Billy Tauzin, PhRMA president and CEO, said: “Our member companies have a longstanding commitment to ethical conduct of clinical trials and to transparency in reporting.“But, we’ve heard the calls that we could do more. And these revised Principles, which come on the heels of our updated Code on Interactions With Healthcare Professionals, further renew our pledge to ‘practice what we preach.’ We hope that all companies that sponsor clinical research and publish results on websites and in peer-reviewed journals will adopt these standards.”

The revisions cover some of the areas that the public, physicians and politicians have expressed concern about but it seems unlikely the principles will alleviate all parties’ worries.

PhRMA has made efforts to resolve issues relating to the low publication rate of some clinical trial results, which gained prominence following a paper in PLoS Medicine that found that 17 per cent of Phase I and 43 per cent Phase II to IV studies were published.

The principles also prohibit physicians being paid in stock options but allow investigators to conduct clinical trials for a company that they already have shares in.

A copy of the complete list of principles can be found here.