Clinical Trials are regulated in Europe by the Clinical Trials Directive (the “Directive”). The UK implemented the Directive into UK law by a regulation (the “UK Regulation”) and this UK Regulation governs the current process for gaining approval to carry out a clinical trial exclusively in the UK. The approval process and protocols for clinical trial approval has been criticised for years as costly, inefficient and burdensome. Medical professionals, patient groups and research organisations have campaigned for reform and in September 2013, the Commons Science and Technology Committee (“the Committee”) released its response to their enquiry on the UK Regulation. This review focussed on UK law, not only in light of the campaigning, but also because a new EU clinical trials regulation (the “EU Regulation”) is currently being debated in the EU Parliament. The government’s response is clinical trial reform, largely shaped by recommendations and endorsements from the Committee.
What are the recommendations from the Committee?
The focus of the Committee is on transparency and this has two limbs: registration and publication of results.
It is estimated that less than half of the clinical trials that take place in the UK are registered. Half of those registered never publish any results, largely due to the results not being favourable to those conducting the trials. This means that tracking the outcome of a high proportion of trials is almost impossible. The significance of this is that treatments that are being used on patients today have a wealth of data sitting behind them that cannot be accessed because, in some instances, we have no idea data exists.
The registration of a clinical trial is not only important so that a clear catalogue of what has been done in the past can be accessed, it is also important to avoid replication and to enable researchers to compare data, particularly in relation to drug efficacy. As a result of this data gap, the Committee proposes that a UK wide audit of all publicly funded clinical trials which have taken place since 2000 should be conducted so that they can be retrospectively registered.
In a positive move, the UK government has made approval to undertake a clinical trial contingent on registration of the trial through the newly established Health Research Authority (HRA). The HRA has responsibility for managing the National Research Ethics Service which now only grants approvals once a clinical trial is registered.
It is estimated that a clinical trial that produces unfavourable results is half as likely to be published than one in which the results are favourable. This has caused grave concern amongst medical professionals and patient groups alike. The fact that vital safety information can be withheld from the public and regulators means that trials are taking place without the effects of some drugs being recorded. This can be particularly contentious when, at a later date, drugs which were once thought safe and effective are discovered to cause adverse and even fatal effects.
Commentators also argue that where the public purse assists in funding these trials, as a matter of public policy, the results should be publicly available.
Commentators believe that the publication of clinical trial results is imperative because all the information (whether good and bad) is required to enable medical professionals to make informed decisions about treatments. Medicines prescribed today are based on the results of clinical trials which took place over a decade ago and as soon as these product come off patent, gaining information about these trials will be much harder.
Data protection concerns
The Committee explicitly stated that it was not in favour of placing anonymised patient data in the public domain at the risk of breaching an individual’s personal data and confidentiality. However, the Committee was in favour of allowing controlled access protected by a “gatekeeper.” From 1 January 2014, companies that are members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) or the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed to adhere to new data sharing principles. Members will now have access to clinical trial data, study level clinical data and protocols from clinical trials but the information will only be provided to specified persons (qualified researchers) and only as necessary for carrying out legitimate research.
Clinical trial reform in the UK is making good progress but there remains some way to go. On a European level, the new EU Regulation only needs to clear the final hurdle of formal ratification by the European Parliament and the Council of Ministers, estimated to take place in the first half of 2014. The EU Regulation, which replaces the Directive, will apply as drafted across all EU member states and will harmonise the clinical trial process across Europe. The Regulation should make pan-European clinical trials easier, reduce costs, improve accessibility to data and enhance transparency. The proposed EU Regulation would create an EU wide database of all registered trials and make publication of summary results and clinical study reports compulsory for all trials used in a marketing authorisation request whether such request is approved, rejected or withdrawn. The intention is to ensure Europe remains an attractive location in which to conduct clinical research while promoting transparency and the best use of clinical trial data. The UK government is hoping that its national reforms will help pave the way for this.