PhRMA Issues Revised Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results: Promises to Provide Results Summaries Even if Sponsor Discontinues Drug DevelopmentApril 21, 2009
On April 20th, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) issued a revised “Principles on Conduct of Clinical Trials and Communication of Clinical Trials Results.” The revision outlines, among other things, the trade group’s Principles on the appropriate conduct of clinical research, registration of clinical trials ¬on a public website, and disclosure of study result summaries.
PhRMA released the revised measures on the same day it testified at a public meeting on issues that the National Institutes of Health will consider as it develops regulations to expand the clinical trial registry and results data bank in accordance with the FDA Amendments Act of 2007 (“FDAAA”) Title VIII. We previously reported on the meeting.
PhRMA first issued its Principles in 2002, and issued revisions in 2004. The Principles address issues including: protecting research participants; conduct of clinical trials; ensuring objectivity in research; and providing information about clinical trials. The revised voluntary code takes effect on October 1, 2009.
Some of the more significant provisions of the Principles are as follows:
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.
PhRMA defines clinical trials subject to registration as those, including Phase I studies, conducted in patients. Use of the word “patients” is significant as PhRMA’s definition excludes most Phase I studies, i.e., those performed in healthy volunteers. In this respect, PhRMA’s Principles may be viewed as more comprehensive than the text of the FDAAA provision, which defines an “applicable drug clinical trial,” subject to the databank registration requirements, to mean, “a controlled clinical investigation, other than a phase 1 clinical investigation.”
PhRMA recommends that sponsors, when registering trials, provide all of the information mandated in FDAAA, even for studies not subject to the new law, “except if providing such information could jeopardize the [product’s] intellectual property protection.”
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.
Conflict of Interest Disclosures for 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. The trade group also recommends that authors identify “individuals who provide writing or other assistance and disclose the funding source for this assistance.” Furthermore, authors should describe several aspects of the sponsor’s involvement with the study.
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. The trade association offers investigators in a multi-site clinical trial an opportunity to review data for the entire study. The document also supports efforts of investigators to communicate a summary of the trial results to research participants after the study ends.
Sponsor 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.
Conforming with PhRMA Code on Interactions with Healthcare Professionals. PhRMA Principles also conform to the revised PhRMA Code on Interactions with Healthcare Professionals, effective January 2009. We previously reported on the revised PhRMA Code, a voluntary code that focuses on appropriate industry interactions with healthcare professionals as they relate to the marketing of products. For instance, the Principles discourage: the use of resorts as venues for meetings with clinical investigators and staff; sponsor provision of entertainment or recreational events for clinical investigators and staff; and sponsor payment of honoraria or travel or lodging expenses for those who are not involved in the clinical trial.