The complexity of working with evolving global health authority requirements on clinical trial disclosure can be significant. The World Health Organization’s statement published on April 14, 2015, defines timeframes for reporting clinical trial results. The Food and Drug Administration Amendments Act (FDAAA) 2007 requires sponsors to register ongoing clinical trials and to report the results of completed clinical trials within certain timeframes on ClinicalTrials.gov. EU regulation Policy 70 mandates public disclosure of clinical trials in an EU public database. Aside from these major regulations, many countries worldwide have their own regulations on clinical trial disclosure. In some countries, there is more than one registry or database for this purpose. We can see that the field of clinical trial disclosure is fluid and being shaped as we speak.
At present, sponsors of multinational clinical trials must coordinate clinical trial disclosure according to international and national guidelines. Challenges of disclosure include collecting data from various sources, data validation, registry input, process tracking, prevention of redundancies in multiregistry postings, and maintaining timelines per each registry.
As the field is still evolving, the international and national regulations will overlap, and redundancies are expected for some period of time. It is vital to achieve an integral process designed purposely to minimize the risk of inconsistent data and noncompliance. Whether you opt for an automated software system or choose to input manually, the following five-step process will help minimize error and optimize efficiency.