The Sunshine Act, in part, expands a well-established FDA rule requiring sponsors to include information on payments to clinical investigators in market applications for new drugs and medical products. That policy aims to uncover financial relationships that could shape how an investigator handles or assesses study results and avoid situations that could compromise the validity of clinical trial data or the safety of study participants. FDA recently published an update to that policy in response to complaints about lax oversight of the program, clarifying how to submit information on various financial arrangements.
Trial transparencyIn addition to reporting payments to independent researchers, there's a broader clamor for transparency in clinical trial activities and study results. After years of reluctance, most pharma companies now post information on active clinical trials on the federal clinicaltrials.gov/ website. Such listings inform patients of opportunities to enroll in research, and also provide a baseline of clinical studies subject to fuller disclosure of trial result summaries after product approval.
Now regulators and health advocates seek to expand disclosure to include findings on all clinical trials, even those for drugs that fail to gain market approval. Leading medical journals are working with European Union officials to promote the AllTrials effort to register and disclose results from all clinical trials around the world. Trial summaries are not enough; safety advocates and industry critics seek disclosure of patient level data and case report forms so that they can verify the sponsor's research results and product claims. Disclosure advocates maintain that it's only fair to clinical trial participants to make available the results of their studies to illuminate further research, pointing out that scientists can learn much even from failed studies.
This call for greater data transparency reflects charges that sponsors have hidden important safety information from regulators and the public. Pharma companies counter that full disclosure can raise patient privacy issues and lead to misinterpretation of findings by non-experts. Abbott's pharma spin-off AbbVie has filed suit to prevent the European Medicines Agency from releasing patient-level clinical trial data, as has InterMune of California.
Yet, a number of pharma companies are adopting a full disclosure policy, some building on research disclosure requirements set in consent agreements negotiated with the Department of Justice and other federal and state enforcers. In February, GlaxoSmithKline announced it would release patient-level data as part of a new "openness" policy. In addition to posting notices on new trials and result summaries, the company will make available clinical study reports for all medicines—approved and discontinued—after results are published. Access to the data (which will be anonymized) will be limited to bona fide researchers and vetted by an independent expert panel.
Roche is taking a similar stance, partly in response to criticism over hiding clinical trial safety reports on its Tamiflu influenza treatment. Roche has formed an independent body to assess outside requests for patient data from trials supporting market applications and will make such information available after product approval in the United States and Europe.