The importance of transparency and data integrity in clinical trials

A joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organization (WHO) calls on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines.

By outlining all of the stakeholders who rely on clinical data for different reasons (academics, researchers, regulators, health authorities and healthcare professionals), the statement aims to bring to attention the importance of increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. Using the COVID-19 pandemic as an example further reinforces the important of publicly accessible data.

In addition, the statement details previous failed initiatives to improve access to research results for all involved in healthcare decision-making. Noting that this was often due to the reliance on goodwill or lack of appropriate resourcing, the two agencies highlight how future initiatives can be more successful by requiring multi-stakeholder engagement aimed at finding solutions that deliver benefits for public health.

The bodies state that the priority should be for new innovative medicines and vaccines and that both positive and negative clinically relevant data should be made available, with only personal data being redacted. The first benefit is public trust, and in the context of COVID-19 vaccination campaigns, this may foster increased vaccine uptake and improved public health outcomes. Furthermore, lack of public access to negative trials has been identified as a source of basis in systematic reviews as the conclusions end up being more positive than the reality.

Furthermore, publication of data enables checking of data integrity, identified as a scientific necessity and an ethical must. Essentially, allowing peer-reviewing of data will minimise the likelihood of damaging regulatory decisions being made on unreliable data. It is also anticipated that the publication of data will allow for more rapid scientific advancements through avoiding the unnecessary repetition of failed trials.

Noting that many stakeholders may be concerned by regulators moving towards an increasingly transparent way of working, the statement reaffirms the overwhelming public health benefits of this. In their closing remarks, the bodies once again use the COVID-19 pandemic as an example of the importance of access to data to ensure public trust, highlighting this in their final call on the pharmaceutical industry to voluntarily commit to unrestricted access to trial results data for the benefit of public health.

The full joint statement can be found here.