Journey from Clinical Data Disclosure Law to Full Transparency

Vera Vanhentenrijk Posted 03 December 2019

Clinical data disclosure is a fast-evolving space, wherein legal requirements have exponentially increased over the past 2 decades. Gone are the days of simply registering a subset of clinical studies on ClinicalTrials.gov.

Nowadays, most interventional trials are covered by one or more protocol registration and/or results disclosure regulations, with the consequential challenge to maintain alignment across all types of disclosure. Standardization is absolutely needed, with -besides FDA and EMA- many individual countries each formalizing their own specific data disclosure regulations.

Keeping abreast and compliant with the vast variety of disclosure regulations is tough as it is. Over the past few years, the focus has expanded progressively towards transparency, making clinical trial information more accessible and understandable. Initially inspired by watch dogs through the AllTrials initiatives like FDAAA Trials Tracker and EU Trials Tracker, the transparency principle is now widely starting to be adopted by trial sponsors.

So far, the focus has been mostly on interventional trials, but voices have raised the need to increase transparency in the non-interventional research domain as well. The ISPOR Real-World Evidence Transparency Initiative has drafted a white paper focusing on the need for study registration as a necessary first step towards improving transparency and trust in non-interventional research for hypothesis testing.

There are two main reasons why full transparency is a goal worth achieving:

  • The first one being to help caregivers and patients understand the full benefit-risk ratio associated with a therapy and to help them take an informed decision, and
  • The second one being to avoid putting patients at unnecessary risks to participate in redundant trials.

Continuously evolving legislation and public expectations bring new challenges that require innovative solutions.

With an expertise of over a decade, we have a team of specialists who deliver high quality disclosure summaries and help you build public trust through transparency. We are more than happy to assist you in this.

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