New Clinical Trial Data Transparency Regulations

The movement toward increased transparency of clinical trial data has accelerated during the past few years as regulatory agencies and pharmaceutical companies have increased their efforts to share data with researchers and the general public.

A recent decision of the European Medicines Agency (EMA) requires pharmaceutical companies selling products in the European Union to publish all clinical reports for a drug, irrespective of its approval or rejection. The data for applications made after January 1, 2015 will be subject to this policy. Existing data for applications filed prior to this date are not subject to the policy.

The European Union’s (EU) new Clinical Trials Regulation is also proposing to increase clinical trial data transparency. This goal will be met through the creation of a database housing:

  • All information submitted as part of the clinical trial application process
  • Summary results for all clinical trials conducted in the EU, regardless of outcome
  • Clinical study reports for all clinical trials used to support a marketing authorization within 30 days of the decision on the marketing authorization

Health and Human Services (HHS) and National Institute of Health (NIH) have also taken steps to enhance the transparency of clinical trial results. A currently proposed rule clarifies requirements to clinical researchers regarding registering clinical trials and submitting results summaries to ClinicalTrials.gov. A primary benefit of registering and reporting results of clinical trials, including positive and negative findings, is that it helps prevent the unnecessary duplication of research.

In addition to policies put in place by governmental agencies, there have been a variety of private efforts by individual pharmaceutical companies undertaken to increase data transparency, while safeguarding individual patient privacy.

Lernia Training Solutions has assisted several pharmaceutical companies in implementing their clinical trial data transparency initiatives. We have designed training for internal and external personnel in understanding the following:

  • Scope and purpose of transparency
  • Standard process and timeline for implementing clinical trial transparency
  • Individual patient level data sharing
  • Data redaction and de-identification
  • Trial registration
  • Portal system

For More Information

If you are interested in how Lernia can provide customized training for your organization on Clinical Trial Data Transparency, contact us at 610-356-1792, or through email at Lernia@lernia-ts.com.

Clinical Trial Data Transparency eLearning Sample

The following eLearning sample contains a process overview for sharing individual patient level data. Please note that the audio narration has been disabled for proprietary reasons.

Clinical Trials Data Transparency eLearning Sample

Data Transparency Links

Principles for Responsible Clinical Trial Data Sharing
HHS and NIH take steps to enhance transparency of clinical trial results

Data Transparency Conference

Clinical Data Disclosure and Transparency | January 28 – 29, 2015 | Philadelphia, PA