A collaborative initiative between leading healthcare professional bodies and senior representatives of the pharmaceutical industry in the UK has published a set of transparency principles aimed at driving best practice in clinical-trial reporting across the research community.
The document, Clinical Trial Transparency Principles and Facts, was launched at a joint British Medical Journal (BMJ)/Association of the British Pharmaceutical Industry (ABPI) conference on ‘Innovation in research methods and dissemination – ensuring best practice’.
It is the first time these two constituencies have agreed to a joint approach on “this critical issue”, noted the Ethical Standards in Health and Life Sciences Group (ESHLSG).
The ESHLSG partners are the Academy of Medical Royal Colleges; the ABPI; Association of British Healthcare Industries; British Medical Association; British Psychological Society; Faculty of Pharmaceutical Medicine; General Medical Council; Institute of Healthcare Managers; Prescription Medicines Code of Practice Authority; Royal Colleges of General Practitioners,_ Nursing,_ Physicians,_Physicians of Edinburgh,_ Psychiatrists__Surgeons, and Surgeons of Edinburgh; and the Royal Pharmaceutical Society.
Moral responsibility
The new publication, which includes information about existing legal and voluntary accountabilities related to clinical-research transparency, cites the “robust” regulatory framework governing disclosure of clinical-trial information, the “many benefits of transparency for all stakeholders”, and “the fact it is impossible to get new medicines approved or data published in the top medical journals without prospective disclosure of clinical trial information on approved registries”.
It talks of a “moral responsibility to both the study participants and society to share results freely _ and thus assist in the development of further research involving better trial design, fewer patients and to avoid unnecessary duplication”.
The nine specific principles listed are:
• 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, and that this information is kept up to date.
• With commercial pharmaceutical trials, investigators should make available the
methods and results of the trial within one year of the product gaining marketing authorisation and being available on the market in any country worldwide.
• Where a product fails to secure to marketing authorisation but the trial results are “of significant medical importance”, they should be made available within one year of the trial being completed, through a publicly accessible website or journal.
• For all other studies or trials, investigators should make available the methods and results within one year of completion through a publicly accessible website or journal.
• Investigators should report the trial “fully and transparently”, following appropriate reporting guidelines, and in particular the recommendation in the current version of the CONSORT (Consolidated Standards of Reporting Trials) statement.
• Investigators should ensure that no “important aspect” of trial results has been omitted, and that any deviations from the study protocol are explained.
• Investigators should ensure that any interpretation of their clinical trial accurately reflects the research questions, study design and results, and is without bias.
• Investigators should report their clinical trial in enough detail to allow other researchers to extract the trial design and data for use in meta-analyses and systematic reviews.
