On April the 20th the Pharmaceutical Research and Manufactures of America (PhRMA) issued a revised “Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results” – These guidelines outlines a number of elements including: Principles on the conduct of clinical research, registration of clinical trials and disclosure of study result summaries. Some of the more important changes include:

Registration of Clinical Trials – PhRMA advises member companies to register on a public database timely summary information about all clinical trials that study products in patients.  PhRMA defines timely as 21 days of enrollment of the first patient in the clinical trial. (this includes phase 1 studies), the PhRMA guidance is more stringent and goes further than FDA rules.

Submission of Summary Results - As it did in its prior version, PhRMA promises to disclose summary results of all clinical trials for approved drugs, regardless of the study’s outcome.  In a major change from its prior version, however, PhRMA also promises to post timely summary results of all clinical trials if the sponsor discontinues development of the drug.  PhRMA defines timely as 12 months after the trial ends, 30 days within drug approval or a year after a company discontinues the drug development program.

Disclosure of Conflict of Interest in Articles - The revision urges sponsors to encourage physicians and researchers to disclose conflict of interest information when authoring manuscripts to medical journals.  Authors that submit a manuscript to a medical journal, according to PhRMA, should disclose “all financial and personal relationships that might bias their work,” and explicitly state whether potential conflicts exist.

Increased Qualifications Needed for Authorship – The revised Principles would make it more difficult to be listed as an author of an article in a medical journal.  These more stringent guidelines adhere to the standards of the International Committee of Medical Journal Editors.

Provision of Study Results to Investigators and Participating Patients – PhRMA directs sponsors to provide all investigators with a full summary of the study results even if an investigator does not contribute to the publication of the study.

Sponsors Right To Review – PhRMA also confirms that sponsors have the right to review manuscripts, presentations, or abstracts that result from the sponsor’s studies or use the sponsor’s data prior to publication or presentation.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  evelopment target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.