Being open on data
A new set of best practice principles are tackling the long-overdue issue of openness relating to clinical research, write Alison McAdams and Olya Melnitchouk
Earlier this year it was reported that a large proportion of evidence from human clinical trials is unreported, and that much of what is reported is done so inadequately.
It is therefore timely that leading UK healthcare organisations, including the medical royal colleges, have joined senior representatives of the UK’s pharmaceutical industry to produce a statement of best practice principles for clinical researchers on transparency and publication of data arising from clinical research activity.
The statement, Clinical Trial Transparency – Principles and Facts, was published by the Ethical Standards in Health and Life Sciences Group (ESHLSG) on 23 May. The ESHLG is a multi-stakeholder group which features leading figures from the health professional community and life sciences industry and aims to improve ethical standards in the wider healthcare and life science sectors.
The principles espoused in the statement are supported by information about the legal and voluntary accountabilities that exist to ensure clinical research activity is transparent, based on:
- A strong regulatory framework to govern disclosure of clinical trial information
- The benefits of transparency for all stakeholders – healthcare providers, healthcare professionals, patients, commercial sponsors and other researchers
- The fact that it is not possible to get new medicines approved or data published in the leading medical journals without prospective disclosure of clinical trial information on approved registries.
Principles of transparent reporting of clinical research studies
Clinical trials are essential in establishing whether a medicine or healthcare product is safe and effective. The principles statement refers to the obligation on investigators involved in clinical trials to report the trial in a timely and non-biased manner.
It further states that there is a moral responsibility to both the study participants and society to share results freely and thereby help in the development of further research involving better trial design, fewer patients and the avoidance of unnecessary duplication.
The specific principles identified in the statement are as follows:
- Investigators should ensure that the methods and plans for their clinical study or trial are recorded on a publicly accessible register within 21 days of initiation of patient enrolment in the trial. This information must be kept up to date.
- In the case of commercial pharmaceutical trials, investigators should make the methods and results of their trial available within one year of the product gaining market authorisation and available on the market anywhere in the world.
- Where the product failed to gain market authorisation, but the results are of significant medical importance, investigators should make those results available within a year of completion of the trial in a publicly accessible website or journal.
- For all other studies or trials, investigators should make available the methods and results of their trial within one year of completion in a publicly accessible website or journal.
- Investigators should report the trial fully and transparently following appropriate reporting guidelines, in particular the recommendation in the current version of the CONSORT statement. (CONSORT, which stands for Consolidated Standards of Reporting Trials, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomised controlled trials. The CONSORT statement is an evidence-based, minimum set of recommendations for reporting such trials.)
- Investigators should ensure that no important aspect of the trial results has been omitted. Any deviations from the study protocol must be properly explained.
- Investigators should ensure that interpretation of their clinical trial is an accurate reflection of the research questions, study design and results, and is unbiased.
- Investigators should report their clinical trial in sufficient detail to enable other researchers to extract the trial design and data for use in meta-analyses and systematic reviews.
- Investigators listed as authors on publications arising from clinical trials have responsibility for all content and should ensure they adhere to the International Committee of Medical Journal Editors guidelines to qualify for authorship.
Frameworks supporting clinical research transparency
The statement explains that these principles are based on a solid commitment from the stakeholders involved in clinical research. It refers to various other initiatives that have been taken to improve transparency.
‘The benefits of transparency are evident for all stakeholders – healthcare providers, healthcare professionals, patients, commercial sponsors and other researchers’
For example, in 2004 the European Medicine Agency established the EudraCT clinical trial database on which prospective registration of trial details is required in order to apply to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for clinical trial authorisation and Research Ethics Committee approval for a study.
In March 2011, data extracted by EudraCT was made available to the public as the EU Clinical Trials Register, which is fully searchable. There are over 18,000 clinical trials recorded in the register. The details in the clinical trail description include the design of the trial, the sponsor, the investigational medicine, the therapeutic areas and the status (for example, authorised, ongoing or complete).
The initiative has made clinical research on medicines more transparent for the public and should help avoid unnecessary duplication of trials. Plans are also under way for the publication of summaries of results in late 2012.
The production of the Clinical Trial Transparency – Principles and Facts statement is the first time that leading healthcare professional bodies and senior representatives of the pharmaceutical industry have agreed to a joint approach to this hugely important issue. The benefits of transparency are evident for all stakeholders – healthcare providers, healthcare professionals, patients, commercial sponsors and other researchers.
The commitment of the breadth of organisations involved in this collaboration has been an extremely important step toward achieving greater transparency in clinical research and ultimately in improving the health of patients.
Alison McAdams is a partner in the product liability group and Olya Melnitchouk is an associate at DAC Beachcroft LLP.