Ensuring that studies and publications address clinically important questions, making public all results in a timely manner, and practicing zero tolerance towards selective or biased disclosure of research results are among the steps that will help to restore the credibility of industry-sponsored clinical research, says the multi-stakeholder Medical Publishing Insights and Practices (MPIP) Initiative.
Ten ‘Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research’ were the outcome of a roundtable convened by the MPIP in 2010, bringing together 23 medical journal editors and pharmaceutical industry representatives. The recommendations were published in the May issue of Mayo Clinic Proceedings.
Founded in 2008 by members of industry and the International Society for Medical Publication Professionals (ISMPP), MPIP seeks to promote more effective partnership between trial sponsors and journals to raise standards in medical publishing and expand access to study results.
The collaboration is co-sponsored by ISMPP with Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Merck, Pfizer and Takeda.
The credibility of industry-sponsored clinical research “has suffered in recent years, undercut by reports of selective or biased disclosure of research results, ghostwriting and guest authorship, and inaccurate or incomplete reporting of potential conflicts of interest”, note Maja Zecevic, North American senior editor of The Lancet, and colleagues in Mayo Clinic Proceedings.
A number of pharmaceutical companies have responded by integrating best practices and recommendations from groups and initiatives such as MIPP, the International Committee of Medical Journal Editors, the Good Publication Practice guidelines, the Committee on Publication Ethics and the EQUATOR (Enhancing the QUAlity and Transparency Of health Resources) Network into their internal policies and standard operating procedures, Zecevic et al add.
All the same, “a credibility gap remains”, and some observers, including journal editors and academic reviewers, “maintain a persistent negative view of industry-sponsored studies”.
Given industry's pivotal role in the development of new therapies, “further improvements in research conduct and disclosure are needed across the industry-investigator-editor enterprise to restore confidence in industry-sponsored biomedical research”, the authors state.
The 10 recommendations in full are:
1. Ensure clinical studies and publications address clinically important questions.
2. Make public all results, including negative or unfavorable ones, in a timely fashion, while avoiding redundancy.
3. Improve understanding and disclosure of authors’ potential conflicts of interest.
4. Educate authors on how to develop quality manuscripts and meet journal expectations.
5. Improve disclosure of authorship contributions and writing assistance and continue education on best publication practices to end ghostwriting and guest authorship.
6. Report adverse event data more transparently and in a more clinically meaningful manner.
7. Provide access to more complete protocol information.
8. Transparently report statistical methods used in analysis.
9. Ensure authors can access complete study data, know how to do so, and can attest to this.
10. Support the sharing of prior reviews from other journals.
“Intended as a ‘call to action’ for all stakeholders, these recommendations provide a road map for authors, editors, and publishers to improve standards applicable to all medical research studies and publications by highlighting critical areas that merit attention in terms of policies, education, and other activities,” Zecevic commented.
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