There has been a lot of discussion recently around greater transparency for clinical trials worldwide. However, clinical trial registry has been something that has been going on for years.
In many countries, it is a requirement for clinical trials to be registered in a publicly accessible database, and beyond that, many regions have localized databases in which trials must be registered. For example, according to the EU Directive 2001/20/EC (Article 9), “Information on the content, commencement and termination of a clinical trial should be available to the Member States where the trial takes place and all the other Member States should have access to the same information.” In conjunction, the US FDA published a final regulation (21 CFR § 50.25(c)) amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. This law also provided for mandatory registration and results reporting of certain applicable clinical trials on www.ClinicalTrials.gov.
In the UK, the Health Research Authority (HRA), implemented a new proposal, which became official on the 30th Sept 2013, in which registration of clinical trial in a publicly accessible database is a condition in order to obtain NHS Research Ethics Committee (REC) approval. This is one of the first steps from the HRA to promote transparency of research in the UK and to improve patient and public confidence in health research.
What we’re seeing now is a growing global need for having more accessible information for all clinical trials, and what I expect very soon is that the information requested from those databases will not only reflect the primary details of the trial and a short summary of the results, but also more specific details. This will provide that transparency of data requested by governments, the public and other health authorities.
What’s necessary to remember is that clinical trials cannot be done without people, and subjects enrolled in a clinical trial have the right to know the final outcome. This is not just about participating—it is about the right of information and transparent access to correct data, even if there are negative outcomes.
In my view, the new draft policy intended to bring greater levels of transparency to clinical trials from the European Medicines Agency (EMA) and the more than 1,000 comments it received that will likely cause a delay in implementation, is just the beginning. Much like the rest of the clinical trial industry, we plan to keep a close eye on what happens next.
The latest information from the EMA can be found here.