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UK health groups publish clinical trial transparency standards

Association of the British Pharmaceutical Industry, Royal College of Physicians and Royal Pharmaceutical Society among members of Ethical Standards in Health and Life Sciences Group

Ethical Standards in Health and Life Sciences Group

Several major UK healthcare organisations have joined together to publish a set of standards to follow on transparency in clinical trials.

Comprising such bodies as the Association of the British Pharmaceutical Industry (ABPI) and the Royal College of Physicians (RCP), the Ethical Standards in Health and Life Sciences Group (ESHLSG) launched Clinical Trial Transparency Principles and Facts at the ABPI and British Medical Journal's joint conference on innovation in research.

Pharma companies have been under fire recently for under-reporting data from clinical trials, with the European Medicines Agency (EMA) calling for greater access to original clinical data after the efficacy of Roche's Tamiflu was challenged by the US Food and Drug Administration (FDA).

According to the ESHLSG, this is the first time that leading healthcare professional bodies and senior representatives of the pharmaceutical industry have agreed to a joint approach to tackle the issue, and say the move is an "important step forward" in driving best practice in clinical research reporting.

The guidelines include a 21 day limit for investigators to publish methods and plans for a clinical study on a publically accessible register once patient enrolment has begun, and that in commercial pharmaceutical trials, investigators should make available the methods and results of their trial within one year of the product gaining market authorisation.

In addition, if the product fails to gain market authorisation, but the results are of significant medical importance, researchers should make those results available within a year of completion of the trial in a publicly accessible website or journal.

These principles are based on the work of the RCP's Medicines Forum - Clinical Trial Transparency Subgroup and are aligned to the Faculty of Pharmaceutical Medicines best practice guidelines and the Code of Practice from international pharma body IFPMA.

"It is in all of our interests to be transparent" said Deepak Khanna, co-chair of the ESHLSH and president of the ABPI, "and it is incredibly encouraging to see the collaborations that have brought about this conference and the publication of the principles document."

He continued: "I'm delighted that so many healthcare leaders are involved in this project – we will be far more effective in finding the right solutions if we work together."

The publication of the principles comes a year after the European Commission opened up clinical trial information to members of the public with the launch of its online EU Clinical Trials Register.

It is intended to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials.

The full list of organisations involved in ESHLSG:

  • The Academy of Medical Royal Colleges
  • Association of the British Pharmaceutical Industry
  • Association of British Healthcare Industries British Medical Association
  • British Psychological Society
  • Faculty of Pharmaceutical Medicine
  • The General Medical Council
  • Institute of Healthcare Managers
  • Prescription Medicines Code of Practice Authority
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Physicians
  • Royal College of Physicians of Edinburgh
  • Royal College of Psychiatrists
  • Royal College of Surgeons
  • Royal College of Surgeons of Edinburgh
  • Royal Pharmaceutical Society.

24th May 2012

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