The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is the global non-profit NGO representing the research-based pharmaceutical industry, including the biotech and vaccine sectors. Its members comprise 25 leading international companies and 45 national and regional industry associations covering developed and developing countries. The industry’s R&D pipeline contains hundreds of new medicines and vaccines being developed to address global disease threats, including cancer, heart disease, HIV/AIDS and malaria.
Recently, IFPMA announced an approved “Joint Industry Position on the Publication of Clinical Trial Results in the Scientific Literature”, which was previously approved by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
According to the Position, the above associations and their member companies and associations committed, as a minimum, “to submit for publication as a manuscript in a peer-reviewed journal, the results of all their industry-sponsored phase III clinical trials, as well as the results of other trials of significant medical importance.” This also includes “investigational clinical products whose development programs are discontinued.” The new Joint Position also requires submission for publication of the results of all trials within its scope, regardless of whether the outcome was positive or negative.
Online registration details and summary results of members’ clinical trials can be located easily, using the IFPMA Clinical Trials Portal.
Mr. Haruo Naito, President of the IFPMA and President and CEO of Eisai, said the new Joint Position is a “logical extension of the previous Joint Position on Disclosure of Clinical Trials.” Since the last position required members to disclose the trials they are undertaking and to publish summary results in online registries, the new Position “requires members to seek scientific journal publication of the results of the specified trials.”
With regards to submission of manuscripts, the Position stated that “industry sponsors should prioritize clinical trials for submission where the results are of high medical or scientific importance.” This should occur ideally within 12 months and no more than 18 months after approval of the product concerned or the decision to discontinue the trial. In the case of trials of a product which is already marketed, submission should ideally be within 12 months of the completion of the trial and not more than 18 months after that date.
In addition, the position adds that primary publication(s) (i.e. the results from all centers) should be published before, or in parallel with, any secondary publications (such as sub-group analyses or results from individual centers). The Position stated that for a “multi-site clinical trial, analyses based on single-site data usually have significant statistical limitations, and frequently do not provide meaningful information for health care professionals or patients.”
The Position also lays down guidelines which enhance transparency regarding the authorship of manuscripts by adopting principles embodied in the ICMJE Uniform Requirements for Manuscripts. Specifically, the position states that criteria for an authorship credit include:
– A substantial contribution to the design of the trial, data acquisition or interpretation;
– Drafting or revision of the text; and
– Final approval
With respect to disclosures, IFPMA also states that “the roles of medical writers, statisticians and other who contribute to a manuscript but who do not meet the authorship criteria should be mentioned appropriately.” Additionally, the new Position states that “company involvement in both the research and publication should be disclosed, and sponsors should encourage authors to disclose all relevant interests.” As such, the Position states that “the primary publication for a particular trial should provide an accurate report of its findings, including adverse events, and there should be a discussion of the strengths and limitations of the study.”
The position also asserts that sponsors should encourage external authors to meet their responsibilities in disclosing all relevant competing interests when submitting a publication or making a presentation. Examples include, but are not limited to, disclosure of an author’s receipt of research grants, author’s receipt of payments for consultant or speaker services, and/or author’s ownership of stock.
Ultimately, the IFPMA hopes that by making clinical trial results widely available through submission for publication, they can continue to demonstrate a commitment to the transparency of clinical trials that are sponsored by its member companies to help the overall public health.