Setting the Record Straight on Transparency

Setting the Record Straight on Transparency

03.23.12 | By

There's been some chatter in the blogosphere lately around our sector's commitment to transparency in clinical trials, with an unfortunate lack of clarity and context. To set the record straight, here's a quick historical overview of our considerable and consistent efforts in this important area.

It should be well recognized by readers of The Catalyst that clinical research is a core element of the R&D process for new medicines. As such, PhRMA member companies have an inherent interest and responsibility in helping to ensure objectivity in research and enhancing the transparency in clinical trials. This commitment is reflected in many ways, including our adoption and continued strengthening of related guiding principles.

PhRMA's publication, Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, has been a valuable guide to member companies since its origin in October 2002. The Principles were revised in 2004, and then again strengthened in 2009. Why? Because as with all of our voluntary guidance documents, PhRMA and its member companies pursue policies and practices that best serve the needs of patients and the healthcare community, revisiting them as necessary to ensure they are appropriately up to date and relevant.

In the 2009 revision, changes included a fortified commitment to increased transparency in clinical trials, enhanced standards for medical research authorship and improved disclosure to manage potential conflicts of interest in medical research.

Let's explore the issue of transparency in clinical trials a bit closer, as it was mischaracterized in a post today on PLOS' blog.

In October 2004, PhRMA sponsored an online database that provided comprehensive summaries of the results of clinical studies of marketed medicines. The purpose was to create a central, easily-accessible resource to better communicate trial results of marketed drugs to healthcare professionals and patients. The motivation in creating the site was to fill a gaping need for such information.

At the time, ClinicalTrials.gov, which was initiated as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA), was still under development and was limited in its scope (for example, it wasn't able to accept Phase IV trial information).

ClinicalTrials.gov was later expanded in 2007 after Congress passed the Food and Drug Administration Amendments Act (FDAAA), which required more types of trials to be registered, additional registration information, and the reporting of summary results, including adverse events, for certain trials. PhRMA supported this heightened disclosure and worked with the National Library of Medicine to help companies post clinical trial data more effectively.

Simply put, PhRMA's database was an interim measure until the ClinicalTrials.gov site was expanded. As ClinicalTrials.gov evolved and companies began creating their own related websites, the need for our database dissolved - hence the decision to discontinue it.

We stand strongly behind the value and importance of transparency - but we also recognize the potential confusion caused by redundancy. Our decision to discontinue our site was made with the best interest of patients and healthcare professionals in mind.

A quick look at the current status on ClinicalTrials.gov speaks volumes. As of 12:50pm (ET) today, the site:

  • Contains information on 123,184 trials sponsored by NIH, other federal agencies, and private industry.
  • Includes studies conducted in all 50 states and in 179 countries.
  • Receives over 50 million page views per month and 65,000 visitors daily.

These are impressive numbers. Our database served an important role for a few years - and we're proud of the leadership we demonstrated and the valuable information it conveyed. But sometimes you have to know when to step aside.

Follow Karl on Twitter @KUhlendorf.

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