7 July, 2015 Lisa Weeks, Marketing Communications Specialist, MasterControl
Transparency has been a hot topic in life science circles in recent years. So hot, in fact, that it has almost become a buzzword, which implies that it lacks real substance or staying power. Transparency advocates, who are pushing to make health industry data—everything from clinical trial results to procedure pricing information—more accessible, would disagree.
The transparency movement sweeping the industry is not just about uncovering financial conflicts of interest in medical and clinical practice vis-à-vis the Sunshine Act/Open Payments. True transparency, advocates argue, will result in better clinical trials, happier patients, improved outcomes and lower costs of care. Moreover, they point out that transparency is inevitable in today’s consumer-centric information age—and it’s accelerating. The movement has already led to widespread changes in the U.S. and abroad, and it is likely to continue to dominate conversations throughout 2015 and beyond.
|Transparency leads to happier patients,
better trials and lower costs, advocates say.
Study Reports One Quarter of Clinical Trial Data Withheld
Medical researchers claim that a substantial amount of clinical trial data goes unpublished, robbing researchers of valuable information and raising ethical concerns about the treatment of trial participants. As an example, the British Medical Journal cited a 2013 study in which of a group of researchers at Cooper Medical School of Rowan University in Camden, New Jersey, examined 585 registered clinical trials that had been completed nearly five years prior. The group found that 29 percent of the trial data sets, with an estimated enrollment of almost 300,000 participants, went unpublished.1
“The non-publication of trial data…violates an ethical obligation that investigators have towards study participants,” said the Cooper team. “When trial data remains unpublished, the societal benefit that may have motivated someone to enroll in a study remains unrealized.”2
The AllTrials Petition
Of the many open data initiatives making the rounds, one that is gaining momentum is the AllTrials petition. As of April 2015, more than 550 government regulatory bodies, clinicians and organizations, including GlaxoSmithKline, had signed the petition, which calls for all past and present clinical trials to be registered and their full methods and summary results to be reported. Failure to do so, according to the AllTrials website, violates the principles of the Declaration of Helsinki, which states that every investigator conducting a clinical trial should register the trial and report its result. Moreover, AllTrials argues that withholding trial results—even negative, null and inconclusive findings—can lead to poor treatment decisions and duplicated research efforts and delay the process of finding positive results. Some investigators and life science companies contend that it is often difficult to find a home to publish null or negative findings. Indeed publication bias, along with the idea that all results are valuable, led to the creation of the Journal of Negative Results in BioMedicine in 2002.3 The Journal was one of the first platforms to push for publication and discussion of null, nonconfirmatory findings.
Other Open Data Initiatives
Large medical device and pharmaceutical manufacturers are contributing clinical trial data sets to Project Data Sphere, the Yale University Open Data Access (YODA) Project, and other programs. As of February 13, 2015, YODA had 112 trials available from the pharmaceutical, medical device, and diagnostics businesses of Johnson & Johnson, as well as Medtronic, Inc. Investigators can submit their data requests on YODA’s website (yoda.yale.edu). “Sharing data from clinical trials leads to greater insights in medicine. This agreement with the YODA Project underscores Johnson & Johnson’s commitment to responsibly share clinical trial data with researchers in a way that we believe advances medical science and public health,” said Dr. Joanne Waldstreicher, chief medical officer of Johnson & Johnson.4
Regulators are on board, too. The European Medicines Agency (EMA) will commence publishing clinical trial data used to support the approval and authorization of new drugs in Europe in 2015. Moreover, the EMA has announced plans to release anonymized patient data in the future. The OpenFDA Initiative, launched last year, provides a public database for analyzing drug and medical device adverse events, recalls and labeling information. In the past, this information was “difficult for industry to access and to use,” acknowledged Taha A. Kass-Hout, M.D., the FDA’s chief health informatics officer and director of its Office of Informatics and Technology Innovation. “Pharmaceutical companies, for example, sent hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database—all slow and labor-intensive processes.”5
Self-regulation in Europe, Australia and Japan
The pharmaceutical industry in Europe has taken an active role in developing a self-regulatory system of transparency. In June 2013, the EFPIA, comprised of 33 national European member associations and forty pharmaceutical companies, adopted the “EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations” (“Disclosure Code”). The Disclosure Code requires members to publicly disclose, in 2016, many of their 2015 financial interactions with health care professionals (HCPs) and health care organizations (HCOs).6 Medicines Australia, whose members deliver 86 percent of the country's pharmaceuticals, hopes to have a similar self-reporting system in place by 2016.
In Latin America, Africa and the Middle East, the transparency movement appears to be in its infancy. Those regions lack both government-driven legislation (e.g., Sunshine Laws/Acts of France and the U.S.) and self-regulatory codes, as does Asia, with the exception of Japan. In Japan, both pharmaceutical and medical device industry groups have self-reporting requirements for their members.
The medical device industry seems to be lagging behind the pharmaceutical industry when it comes to self-regulation. Though Eucomed, AdvaMed’s European counterpart, “strongly supports transparency as a broad principle,” its members are not, at this time, subject to EFPIA-like reporting requirements.
Implications for Device Makers
The ever-expanding movement toward greater transparency with respect to pricing and financial interactions between industry and providers continues to pick up steam. Life science companies around the world have been forced to confront both government-imposed and self-imposed reporting obligations, and further enforcement is anticipated. Data sharing and reporting across companies and continents is quickly becoming a reality. Medical device companies would be wise to invest in data sharing and analytics software that will help them gain a competitive edge.
Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.
(1) “Ethical Failure Leaves One Quarter of All Clinical Trials Unpublished, October 29, 2013. (http://blogs.nature.com/news/2013/10/ethical-failure-leaves-one-quarter-of-all-clinical-trials-unpublished.html)
(3) Flemying, Ella and Shanahan, Daniel, “Overcoming Publication Bias In Clinical Trials,” March 17, 2015. (http://www.alltrials.net/news/overcoming-publication-bias-in-clinical-trials-jnrbm-article-collection/)
(4) Peart, Karen N., “Yale YODA Project Announces First Availability of Medical Device Trial Data,” Yale News, January 14, 2015. (http://news.yale.edu/2015/01/14/yale-yoda-project-announces-first-availability-medical-device-trial-data)
(5) Kass-Hout, Taha A.,“OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data,” FDA Voice, June 2, 2014. (http://blogs.fda.gov/fdavoice/index.php/2014/06/openfda-innovative-initiative-opens-door-to-wealth-of-fdas-publicly-available-data/)
(6) Campbell, D. Jeffrey and Sharkey, Brian P.,“Do Start Believin’: The Life Sciences Industry’s Journey to Global Transparency,” August 2014. (http://www.pbnlaw.com/media/510344/Do-Start-Believin-White-Paper.pdf)