Industry takes heat for delaying trial-data release, and for the degree of openness around research and publication. But for disclosure and publication of trial results, is academic research any more timely or transparent?
Robert J. Matheis, PhD*
Senior Director and Head, Medical Communications, Sanofi; President (2011-2012), International Society for Medical Publication Professionals (ISMPP)
Virtually anyone engaged in scientific study is faced with a potential bias, such as supporting a hypothesis, securing tenure, or favoring a commercial interest. Professional ethics must be exercised to preserve scientific integrity. The pharmaceutical industry has received particular media attention around publication practices because commercial interests and the potential for bias are visible in this sector. This has generated a level of self-regulation in industry that may have tempered the issue compared with researchers under less scrutiny. Still, ISMPP supports appropriate and ethical disclosure of data among any entity engaged in scientific research.
*This response represents the opinion of the respondent and not necessarily the opinions of Sanofi.
Karen Woolley, PhD CMPP
CEO, ProScribe Medical Communications; Director, ISMPP and Chair, ISMPP Asia-Pacific Advisory Comm.
The spotlight on non-publication has turned from industry to academia… and the results are alarming. Fewer than half of NIH-funded trials are published 2.5 years after completion and a third remain unpublished after 4 years (BMJ 2011;344:d7292). FDAAA requirements have been violated for four of every five applicable trials on clinicaltrials.gov and industry critics have yet to explain why disclosure for trials without industry funding was four times worse than that for trials with industry funding (BMJ 2011;344:d7373). We can blame researchers, but it might be more useful to provide them with ethical medical writing support. If tax-payer-funded research isn’t shared, why should tax payers fund it?
Kirby Lee, PharmD, MA, MAS
Associate Professor of Clinical Pharmacy, University of California, San Francisco
Egregious cases and empirical evidence document delays in publication of trial results and failing to disclose conflicts of interest. The data that suggest this problem is not widespread in academia, but are limited by self-reporting (those willing to tell) and publicly identified cases or lawsuits (those who have been caught). The magnitude of misconduct in academia is underestimated but evidence shows that faculty with industry relationships are more likely to delay publication.
Financial incentives are a strong driving force for scientific misconduct in both academia and industry and the new “sunshine” law of the Patient Protection and Affordable Care Act in the USA will help shed light on the financial relationships of faculty.
Joseph Ross MD, MHS
Assistant Professor, General Internal Medicine, Yale University School of Medicine
Whether academia is better or worse than industry, it is a matter of degrees. We know that neither party is particularly good. Regardless of trial sponsor, the stakes are higher when industry delays release of trial data. One company decides which data to publish as a drug comes to market, shaping knowledge and practice for years to come.
Steps must be taken to ensure timely and transparent disclosure and publication of trial results, and the sharing of clinical trial data, so that data from all those who volunteer are available to inform future research and practice.