Science and Technology CommitteeJoint written evidence submitted by the Royal Pharmaceutical Society and the National Pharmacy Clinical Trials Advisory Group (NPCTAG)

The Royal Pharmaceutical Society (RPS) is the professional body for pharmacists in Great Britain. We are the only body that represents all sectors of pharmacy in Great Britain.

The RPS leads and supports the development of the pharmacy profession including the advancement of science, practice, education and knowledge in pharmacy. In addition, we promote the profession’s policies and views to a range of external stakeholders in a number of different forums.

The National Pharmacy Clinical Trials Advisory Group, originally a subgroup of the National Pharmaceutical Quality Assurance Committee, was established in its current form in 2010. Membership includes representatives from a range of hospital pharmacy disciplines and other relevant specialist groups, Medicines and Healthcare products Regulatory Agency and the National Institute of Health Research. The group’s objectives are to provide advice to NHS pharmacy services, to the National Institute of Health Research Clinical Research Networks Coordinating Centre, to support education and training of pharmacy staff, and to provide a forum for communication with MHRA about clinical trials.

Herewith our response to the Inquiry:

Q1. Do the European Commission’s proposed revisions to the Clinical Trials Directive address the main barriers to conducting clinical trials in the UK and EU?

We welcome the proposed revisions to the Clinical Trials Directive, and strongly support the aims to drive consistency across the European Union and to adopt a risk-adapted approach to the approval and conduct of clinical trials. The introduction of a coordinated authorisation process should help to reduce the regulatory burden on investigators and sponsors, and to optimise efficiency and maximise system capacity to undertake clinical trials. However, the proposal as it stands is very low on detail, and the practical implications therefore remain unclear and we recommend the development and publication of guidance to support applicants.

Q2. What is the role of the Health Research Authority (HRA) in relation to clinical trials and how effective has it been to date?

We believe that, in the UK, more could be done to improve effectiveness in clinical trials; there are still too many barriers and sponsors continue to look elsewhere to conduct clinical trials, particularly where regulatory and financial hurdles are considered less onerous. Timeliness, cost, effective patient recruitment and inability to embed clinical research as part of standard practice are still areas for concern. Furthermore, there is a perceived reluctance to become involved in clinical research and in particular clinical trials for a variety of reasons including time, cost, resources, increase in workload and lack of appropriately trained clinical research staff.

Although the HRA has existed since December 2011 there seems to have been little awareness amongst pharmacists until publication of the statement on GCP training last year. From our point of view, HRA would therefore seem to have had little impact.

Q3. What evidence is there that pharmaceutical companies withhold clinical data and what impact does this have on public health?

The majority of sponsors register their trials on the US database;1 a registry and results database of publicly and privately supported clinical studies of human participants, conducted around the world which provides patients, family members and the public with information about current ongoing clinical research studies. We believe that registration of trials on this database should be an expectation of all clinical trial sponsors. To identify the gap between those studies registered and those subsequently published would provide valuable information.

The Society is strongly committed to increased clinical trial transparency and has signed up to active membership of the AllTrials campaign. Encouragingly, GlaxoSmithKline has recently announced that they will make results on all their trials available. This obviously will not happen overnight, but we believe this is a step in the right direction and would be keen to see all pharmaceutical and biotechnology companies follow suit.

The European Union requires end of study reports to be filed on all trials involving IMPs within a specified time—so it is difficult and illegal to withhold clinical data. However, while most sponsors will agree to publish, timeliness of publication may be an issue. Some journals may not be keen to publish some of the less interesting, negative trials, which may still have great importance when undertaking systematic reviews of the available evidence. Ways need to be investigated to ensure the rapid publication of all data, which would apply to the entire research community, not just those engaged in clinical trials.

It is frequently challenging to obtain clinical information on medicines outwith the Summary of Product Characteristics and published clinical trials, such as information on drug stability in solution, or administration by a route not referenced in the SPC. Additionally, transition during merger of Pharmaceutical Companies can also lead to reduced access to, and in some cases, even apparent loss of data. Furthermore, Pharmaceutical Companies often make reference to “data on file” but these original data are difficult to access or may be quoted without full context. It is extremely frustrating, and unacceptable from a patient safety view point, when access to data is refused (sometimes for unverifiable reasons) even though the manufacturer admits to having the information.

Q4. How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?

In the UK, regulatory access to allow inspection against academic data and publications as well as against commercial data would make clinical trials more open to scrutiny, especially trials initiated in the non commercial/academic sectors. The HRA is best placed to be responsible for this.

In the European Union, a database of all trials and their results could be published as the data is already in the system. We would suggest that the European Medicines Agency be responsible for this activity.

Q5. Can lessons about transparency and disclosure of clinical data be learned from other countries?

We are not aware of evidence that other countries fare any better or worse and are unable to comment on this point.

March 2013

1 www.clinicaltrials.gov

Prepared 16th September 2013