Reply to F.E. Vera-Badillo et al
Authors: Richard L. Schilsky
Journal: Journal of Clinical Oncology (2014)

Vera-Badillo et al write to share their reaction to American Society of Clinical Oncology’s (ASCO) recent decision to halt implementation of author restrictions described in our 2013 Policy for Relationships With Companies. Vera-Badillo et al applaud ASCO’s move to improve transparency of relationships between the authors of research in ASCO forums and the commercial sponsor of that research, but take issue with the suspension of enforcement of certain restrictions outlined in the 2013 Policy. ASCO expects that disclosure of financial relationships and rigorous peer review will continue to be the primary methods of producing unbiased, trustworthy scientific content. The writers are correct that during the 3-year period of data gathering and review, ASCO will consider all content submitted to journals and meetings. All authors will be required to make general disclosures of all of their relationships with for-profit health care companies; first, last, and corresponding authors will further disclose their relationships with sponsors of their research. Peer reviewers will have access to this disclosure information as they evaluate the content of abstracts and manuscripts and presentation or publication of accepted materials will be accompanied by disclosure of financial relationships as has customarily been the case. Vera-Badillo et al urge ASCO to maintain restrictions on authors reporting on clinical trials, even though they agree that “researchers working for private companies . . . deserve to be first, last, or corresponding authors.” Of note, ASCO’s 2013 policy, unlike previous policies, imposed restrictions not only on the authors of clinical trials, but of all original research. As defined in the policy, “original research” means a systematic investigation designed for the purpose of expanding knowledge or understanding, including analysis of data. As the oncology environment has evolved, the potential for bias in reporting of translational, preclinical, and other types of research that are not clinical trials has emerged. The attempt to establish separate rules based on meaningful distinctions between clinical trials and other original research proved to be impossible. Indeed, as VeraBadillo et al point out, clinical trials are most often conducted and reported by academic clinicians rather than by company employees. ASCO determined that the greatest value would come from collecting data on the reported relationships of authors of all types of original research, including clinical trials. Equipped with this information, the organization will be better informed to identify and manage potential conflicts of interest in research, including possible policy revisions. Other types of bias, such as bias in the reporting of end points and the prevalence of positive conclusions in industry-sponsored research, are a serious concern and may not be responsive to restrictions on author relationships. One advantage of suspending the restrictions has already been realized, however: ASCO members have voiced their opinions on the impact and appropriate management of conflicts of interest. We hope that this dialogue will continue as ASCO considers the path forward.