Clinical trial data for all drugs in current use

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7304 (Published 29 October 2012) Cite this as: BMJ 2012;345:e7304

Re: Clinical trial data for all drugs in current use

Dear Editor,

We note the British Medical Journal’s pledge to only publish results of clinical trials where access to patient level data is made available on reasonable request from January 2013. We are keen to understand in more detail how decisions to publish clinical research data will be applied.

ABPI member companies have supported clinical trial registries and results databanks, including the legislation that led to the development of databases such as ClinicalTrials.gov in the United States. The purpose of such transparency is to provide useful information about clinical trials for patients and healthcare professionals. ABPI member companies are also committed to disclosing clinical trial information at the time of patient enrolment, drug approval, and for medicines whose research programs have been discontinued. These and other efforts to enhance the transparency of clinical research are reflected in the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (2009) and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (2010) issued by the IFPMA, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) and also the 2009 revisions to PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results.[1] Indeed, many companies are continuing at pace to further broaden the modes of access to clinical trial data.

While supporting enhanced transparency of clinical research and safety information, it must be balanced with the need to ensure that disclosure policies protect patients’ personal data, intellectual property rights and confidential commercial information associated with innovative research and development. The public health is not well served by dis-incentivising research based biopharmaceutical companies and commercial organisations from other life science sectors from making the substantial investments and shouldering the risks that are necessary to develop new innovative medicines.

While the publication criteria for clinical research papers is a matter for the BMJ, having partnered BMJ Group in the Innovation in research methods and dissemination - ensuring best practice conference (May 2012) we would have appreciated the opportunity to discuss BMJ’s new position in advance of publication. In particular to understand:

• If the same criteria will be applied to studies by commercial organisations, academia and charities across diagnostics, devices and biopharmaceuticals?
• Does the pledge apply to all studies, (including those in healthy subjects), irrespective of where they are conducted or only those studies with centres in the UK?
• Do the criteria apply prospectively only to studies conducted from January 2013 or retrospectively on all studies?
• How is reasonable request being defined by the BMJ?
• Who will assess that a request is reasonable? How will this be determined in advance of publication by BMJ?
• If BMJ supports the use of confidentiality agreements where access to patient level data is granted following a reasonable request in order to protect commercial in confidence information?
• If the criteria will be applied to meta-analysis?
• What steps does BMJ envisage will be required in respect of protected personal data of patients, employees and other parties involved in a clinical study?

From a wider perspective, clinical research is truly a global process in bio-pharmaceuticals and across the wider research community. Our view is that work to continue the journey to greater access to trial data needs to be approached at a global level and in partnership with all relevant stakeholders. It is an iterative process which has been advancing rapidly over recent years and continues to do so.
In that context, we are keen to understand if your signature on the letter to the Times advocating changes to UK legislation on the issue of disclosure indicated your personal perspective or if BMJ views unilateral action in the UK beyond globally agreed positions on disclosure as the right approach for clinical research in the UK? I am sure the ABPI and the BMJ are united in their desire to continue to see the UK as a leading centre for clinical research. Part of that equation is ensuring that we play an active role in the international journey towards greater clinical trial data transparency whilst ensuring our regulatory environment is aligned with European and Global standards.

I look forward to hearing your views and hope that our organisations can continue to keep an open dialogue on the issue.

Yours sincerely

Stephen Whitehead

[1] See PhRMA, Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results (2011), available at http://www.phrma.org/sites/default/files/105/042009_clinical_trial_princ....

Competing interests: No competing interests

13 November 2012
Stephen Whitehead
Chief Executive
Association of the British Pharmaceutical Industry
7th Floor, Southside, 105 Victoria Street, London SW1E 6QT