This is a guest post by Janet Wisely, Chief Executive of the Health Research Authority, which is a supporter of the AllTrials campaign.
The problems with the failure to register and publish trials are well documented. The HRA is looking at practical measures to support, ensure and demonstrate the registration and publication of clinical trials in the UK.
Good progress has been made on studies falling under the EU Clinical Trials Directive – albeit with some exceptions. These are automatically registered on the EU Clinical Trials Register. Many funders require registration and publication and, notably, the National Institute for Health Research has measured excellent levels of compliance. However it has been difficult to compile a national picture – to identify failure or promote success.
The HRA has identified a role and opportunity that will require and measure compliance to build patient and public confidence in health research; take pragmatic and transparent decisions to support a delay to registration where there are genuine commercial or intellectual reasons to ensure the UK retains competitiveness in a global market; and identify and expose any failure to register.
Registration of clinical trials is now a condition of the NHS Research Ethics Committee (REC) approval. Researchers are required to inform the REC of plans for publication, and the HRA is looking at simple measures to monitor compliance.
So what, say a scornful few, what can you actually do, where are your teeth? The HRA is fully aware of its limitations; sponsors and employers are accountable for the conduct of research, we will not use our relatively modest funds treading on those toes…and the legal requirements have not delivered success to date anyway.
The strength of the HRA approach is that we can require compliance and, perhaps more importantly, we will know whether people have honoured their commitment; we can therefore celebrate the good and expose the bad on a national scale.
There is still much to do and some genuine hurdles to overcome. We need standard fields for registration and (preferably global) standards for registers. In the UK there is opportunity to build a direct feed from the Integrated Research Application System (which is also provided by the HRA) in due course. We need to describe what we mean by publication of results and ensure this is considered for the different audiences – the participants in the trial, academics, clinicians and patients.
Registering all trials will not achieve transparency in health research by itself, and indeed the HRA cannot achieve this without the collaboration of partners, including those in industry. It is, however, a major step forward, and the first milestone along our path to making the sharing of scientific evidence the norm for all.