Clinical Trial Disclosure Compliance A Moving Target Due To Ever-Changing Global Regulations

Ensuring clinical trial disclosure compliance remains a challenge for sponsors, irrespective of the number of trials they conduct or the countries involved. For sponsors with trial sites spanning multiple nations, the ever-evolving global regulations add complexity. This year alone, there have been 115 updates across global regulatory agencies, resulting in 59 updates to the TrialScope Intelligence database. These updates affect various countries, including Australia, Bosnia, Canada, Germany, India, Latvia, Panama, Peru, Serbia, Slovakia, Switzerland, and Thailand.

Common global disclosure updates encompass new guidance documents, newsletters (particularly from the European Medicines Agency due to the Clinical Trial Information System portal), and authority notifications. Regulatory agencies have been continuously refining disclosure rules, including significant developments in 2020 triggered by the COVID-19 pandemic and Brexit.

In the future, sponsors may need to address data anonymization from devices like mobile phones and wearables, possibly leading to more targeted regulations for data capture through such technologies. Review what other types of changes have occurred, where they were, and how they are implemented by accessing the white paper below.