The MPIP recommendations for closing the credibility gap
The ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research were developed by journal editors and the pharmaceutical industry together. They answer damage done to the credibility of industry-sponsored research, come from an initiative that pharmaceutical companies sponsor, and are meant to reach beyond industry sponsorship.
What the ten recommendations ask
The recommendations were published in the May 2012 issue of Mayo Clinic Proceedings. They were developed at a roundtable of journal editors and industry representatives that the Medical Publishing Insights and Practices initiative (MPIP) convened in 2010.
In their published order, the ten recommendations are:
- Ensure clinical studies and publications address clinically important questions.
- Make public all results, including negative or unfavourable ones, in a timely manner, while avoiding redundancy.
- Improve understanding and disclosure of authors' potential conflicts of interest.
- Educate authors on how to develop quality manuscripts and meet journal expectations.
- Improve disclosure of authorship contributions and writing assistance, and continue education on best publication practices to end ghostwriting and guest authorship.
- Report adverse event data more transparently and in a more clinically meaningful manner.
- Provide access to more complete protocol information.
- Transparently report statistical methods used in the analysis.
- Ensure authors can access complete study data, know how to do so, and can attest to this.
- Support the sharing of prior reviews from other journals.
Behind the first recommendation lies the point that credibility is compromised when clinical research is intended for marketing purposes rather than for advancing scientific and medical knowledge. Sponsors could enhance transparency and credibility by better explaining the rationale behind the research and by ensuring that it is designed to answer important clinical and scientific questions.
The credibility problem they answer
Reports of ghostwriting, guest authorship, selective or biased disclosure of research results, and inaccurate or incomplete reporting of potential conflicts of interest had damaged the credibility of industry-sponsored clinical research. For example, an analysis of the financial conflicts of interest of the American Psychiatric Association members responsible for updating the Diagnostic and Statistical Manual of Mental Disorders found that nearly 70% of those responsible for its fifth version had financial relationships with pharmaceutical companies, which raised concern that so many of the experts who define mental health conditions and their treatments had such ties. Pharmaceutical companies were trying to improve this by using recommendations from the International Committee of Medical Journal Editors (ICMJE), Good Publication Practice, the Committee on Publication Ethics, the EQUATOR network and MPIP itself. Important improvements had been made, but a negative view of industry-sponsored research remained, and in 2010 MPIP convened journal editors and industry representatives to resolve it.
The initiative behind them
MPIP was founded in 2008 by members of the pharmaceutical industry and the International Society for Medical Publication Professionals (ISMPP) to elevate trust, transparency and integrity in publishing industry-sponsored studies. It seeks to promote more effective partnership between sponsors and journals to raise standards in medical publishing and expand access to study results. In 2012 it was co-sponsored by Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Merck, Pfizer, Takeda and ISMPP. In 2018 its corporate sponsors were Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Global Services, Merck and Pfizer.
Through collaboration with key stakeholders, MPIP works to understand the issues and challenges in reporting industry-sponsored research, publishes its findings, and develops tools to improve credibility and transparency. At the core of these efforts in 2018 was Transparency Matters, a global education platform and resource hub where anyone with an interest in the transparent reporting of clinical trial results can find research, tools and recommendations. It offered two ways to take part: the Transparency Pledge, a commitment to transparent publication practice when reporting pharmaceutical and biomedical research, and What Transparency Means to Me, a space for those involved in reporting research to share their perspectives on transparency and how it can best be achieved when disclosing data. Its blog carried expert commentary on subjects such as the ICMJE data-sharing statement, predatory journals and congresses, and the future of peer review.
How far they reach
Their authors hold that, although framed in the context of industry sponsorship, the ten would enhance the credibility of clinical research publications in general, regardless of the funding source. In 2018 writers from MPIP's sponsor companies and ISMPP held that they can equally be applied to the reporting of all research, regardless of funding source or research type. Their corresponding author describes them as intended as a call to action for all stakeholders and as a roadmap for authors, editors and publishers to improve standards applicable to all medical research studies and publications, by highlighting critical areas that merit attention in policies, education and other activities. They will be of interest to medical writers working with publications in the pharmaceutical industry.
In 2012 the American Medical Writers Association encouraged its members to review the recommendations and take steps to adhere to them, and made them available with other relevant guidelines through its website. It applauded the MPIP co-sponsors for collaborating with journal editors to characterise the credibility gap and identify potential approaches to resolve it. The same 2018 writers hold that professional guidelines such as Good Publication Practice (GPP3) and the ICMJE recommendations are an excellent starting point for transparent practice, and that MPIP's work, which includes the ten recommendations, supplements them.