Given the current debate surrounding recent European initiatives, including the European Medicines Agency’s publication and access to clinical trial data draft policy, analyzing the benefits and risks of enhanced disclosure, such as effects on patient care and the public’s health, is timely, according to the report.
The new report, "In the Patient’s Interest: Improving Access to Clinical Trial Data" looks at the benefits and risks of enhanced clinical trial data disclosure and identifies three key issues: 1) obligations to clinical trial study participants; 2) privacy; and 3) data quality. Avalere Health’s research found that "these three issues warrant immediate consideration because if mismanaged, they could sabotage the ability of enhanced transparency to benefit the public." Released data cannot be recaptured and so inadvertent consequences must be considered pre- rather than post-release.
As such, the report outlines tools and strategies to help implement enhanced transparency policies to ensure patients benefit, including accountability for the release of data; educational campaigns; training for researchers; tools to facilitate informed consent; organized consensus meetings around clinical data standards; mechanisms to validate secondary research; and outcomes assessments.
To speak to an Avalere expert about this report, please contact Frank Walsh at firstname.lastname@example.org or 504-309-5164.
View Avalere’s complete report attached.