Open Access News

News from the open access movement


Friday, October 02, 2009

New drug industry guidelines on clinical trial info

The Pharmaceutical Research and Manufacturers of America (PhRMA) new Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results took effect on October 1. (Thanks to the Wall Street Journal Health Blog.) The voluntary guidelines describe ethical standards for industry-sponsored clinical trials.

... Americaís pharmaceutical research companies are committed to the transparency of clinical trials that are sponsored by our member companies. We recognize that there are important public health benefits associated with making appropriate clinical trial information widely available to healthcare practitioners, patients, and others. Such disclosure must maintain protections for individual privacy, intellectual property, and contract rights, as well as conform to legislation and current national practices in patent law.

Availability of information about clinical trials and their results in a timely manner is often critical to communicate important new information to the medical profession, patients and the public. ...

We commit to the timely submission and registration on a public database of summary information about all clinical trials that we conduct involving the use of our marketed or investigational products in patients ... regardless of outcome. In addition, if information from any clinical trial is felt to be of significant medical importance, then we will work with investigators to publish the data. ...

We seek to provide investigators with meaningful access to clinical data from the studies in which they participate. ... Sponsors will make a summary of the study results available to the investigators. In addition any investigator who participated in the conduct of a multi-site clinical trial will be able to review relevant statistical tables, figures, and reports for the entire study at the sponsorís facilities, or other mutually agreeable location. ...

This summary could be the primary manuscript submitted for publication, a slide presentation, or a synopsis of the sponsorís Clinical Study Report (CSR).

Investigators who participated in the conduct of a multi-site clinical trial and are interested in more extensive data displays will be able to review data for the entire study at the sponsorís facility or other mutually agreeable location in response to a reasonable scientific inquiry. Investigators who are authors of study-related manuscripts will be given all study data needed to support the publication. ...

Investigators are encouraged to communicate a summary of the trial results, as appropriate, to their research participants after conclusion of the trial. As research sponsors, we will support investigators in this regard. ...

If requested by a medical journal when reviewing a submitted manuscript for publication, the clinical trial sponsor will provide a synopsis of the clinical trial protocol and/or prespecified plan for data analysis with the understanding that such documents are confidential and should be returned to the sponsor. ...

For clinical trials subject to the FDAAA, companies should list the data elements required by the statute [when registering the trial]. In addition, companies should consider providing the FDAAA data elements for all other clinical trials covered in these Principles, except if providing such information could jeopardize the intellectual property protection with respect to the product. ...

As a general matter, if the company acts as the sponsor of a clinical trial, it should work with the investigator to publish or disclose results from clinical trials of drugs. ...

For purposes of investigator access to data, relevance refers to data from the trial and is determined by the study design and pre-stated research objectives. Simply stated, investigators will be given access to any tables, figures, and reports they need from the study that are related to the hypothesis being tested or explored or which are needed in order to understand the results of the study. ...