See-Through Clinical Trials

By: Karen Brown, CIS Marketing Director
karenbrown@cis-partners.com

In a continued effort to push for more transparency around clinical trial data, Pharmaceutical Research and Manufacturers of America (PhRMA) has updated the 2002 Principles of Conduct of Clinical Trials and Communication of Clinical Trial Results. [1]

The revised voluntary Principles, which take effect on October 1, 2009, require PhRMA’s member companies to record “the timely registration of all interventional clinical trials involving patients – including some early Phase 1 studies – on a public website, to help patients who need medical care to enroll in relevant studies.” [2]

According to the Principles, “timing” is within 21 days of enrollment of the first patient. With regards to Phase I studies, it’s a little more ambivalent, and is best described in this PhRMA Q&A:

Q: Company D has completed an exploratory, controlled clinical trial in healthy
adults of a product involving a novel and highly proprietary study design.
Should Company D communicate the results of this trial?

A: Perhaps.
Exploratory trials conducted in healthy adults rarely provide information of
significant medical importance. However, if such a trial did provide significant
medical information, sponsors should work with the investigators to communicate
the results of the trial. [1]

PhRMA also notes that this commitment extends to “all interventional clinical trials involving patients – regardless of whether the medicines are approved or the particular research programs have been discontinued.” [2]

Under these Principles, if the clinical trial results are thought to be of significant medical importance, the sponsor should work with investigators to communicate the results of the trial through posting or publication.

And, when it comes to publishing results, changes involving research paper authorship include:

• Adoption of the International Committee of Medical Journal Editors (ICMJE). Under these revised Principles, only individuals who make substantial contributions to medical manuscripts will be recognized as authors.
• Further alignment with ICMJE standards regarding disclosure in medical journal manuscripts of all financial or personal relationships that might present a conflict of interest – whether in an article or a letter. What’s more, authors of medical journal manuscripts should describe the role of sponsors in designing the study, collecting and interpreting data, and writing the report. [2]

Sources:
1. http://www.phrma.org/files/042009_Clinical%20Trial%20Principles_FINAL.pdf
2. http://www.phrma.org/news_room/press_releases/revised_clinical_trial_principles_reinforce_phrma%92s_commitment_to_transparency/