Wednesday, February 06, 2013

Concerned Pharmacists Sign the AllTrials petition



From Mrs A. E. Bithell, MRPharmS, and others


We write as concerned pharmacists about the issue of missing clinical trial data. The effectiveness and safety of medicines is of interest to all pharmacists in all sectors of the profession. Unpublished clinical trials skew the evidence base on which their harms and benefits can be assessed, and ultimately lead to patient harm and wasted health resources. How can pharmacists advise others on the safe and effective use of medicines, or prescribe them, when the sources of information we use have not assessed the entirety of the evidence?

It has been estimated that around half of clinical trials have not been published1 and this occurs regardless of whether the study was performed by the pharmaceutical industry or not, the stage of drug development or the size of the trial.2 Current initiatives to tackle the problem have failed. Journal requirements for trials to be registered have not been enforced,3 the European Medicines Agency clinical trials register has failed to open up data fully,4 and US Food and Drug Administration legislation on trials has not been effectively enforced.5 Additionally, many of these initiatives only deal with contemporary studies based in western countries. Older trials, and those by contract research organisations in countries such as Brazil and India, are excluded.

Currently the Royal Pharmaceutical Society is a member of the Ethical Standards in Health and Life Sciences Group. One of its objectives is to “promote best practice in clinical trial reporting and publications across the research community”6 and it recently claimed “information about industry-sponsored trials is publicly available”.7 Unfortunately, this claim is not supported by evidence. For example, the Cochrane Collaboration has been in a protracted campaign to obtain the full data for oseltamivir (Tamiflu) with the support of the BMJ’s Open Data campaign. It estimated that 60 per cent of phase III trials had not been published.8

The All Trials campaign (www.alltrials.net) has attracted more than 10,000 individual signatories to its petition calling for full transparency on clinical trials, and the support of several organisations, including the Cochrane Collaboration, the Medical Research Council and the Royal Statistical Society.

We call on individual pharmacists to sign this petition, and urge the Royal Pharmaceutical Society to demonstrate our profession’s leadership on medicines by signing it, too.


Anne Bithell

Chief Pharmacist, Betsi Cadwaladr University Health Board

Chairman, All Wales Chief Pharmacists Committee


Paul Baker

Hospital Pharmacist

Birmingham


Alison Blenkinsopp

Professor of the Practice of Pharmacy

University of Bradford School of Pharmacy


Mark Borthwick

Chairman

United Kingdom Clinical Pharmacy Association



Anthony R. Cox

Lecturer in Clinical Pharmacy

University of Birmingham


Rob Davies

Primary Care Pharmacist

Mold, Clwyd


Ryan Hamilton

PhD Student

Liverpool John Moores

University


Philip Howard

Chairman

UK Consultant Pharmacists Group


Dyfrig Hughes

Centre for Health Economics and Medicines Evaluation

Bangor University


Warren Linley

Senior Research Fellow

Centre for Health Economics and Medicines Evaluation

Bangor University


Katherine Payne

Professor of Health Economics

Manchester Centre for Health Economics

University of Manchester


James B. Semple

Vice-chairman

Community Pharmacy Scotland



J. A. Schofield

Community Pharmacist

South Shields



References

1 Song F, Parekh S, Hooper L et al . Dissemination and publication of research findings: an updated review of related biases. Health Technology Assessment 2010;14(8).
2 Ross JS, Mulvey GK, Hines EM et al. Trial publication after registration in ClinicalTrials.gov: a cross‐sectional analysis. Sim I, editor. PLoS Medicine 2009;6:e1000144.
3 Mathieu S, Boutron I, Moher D et al. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009;302:977–84.
4 G√łtzsche PC. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686.
5. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012;344:d7373.
6. Ethical Standards in Health & Life Sciences Group. About us. http://www.eshlsg.org/about-us/ (accessed on 30 January 2013).
7. Guidance on collaboration between healthcare professionals and the pharmaceutical industry. Ethical Standards in Health & Life Sciences Group. April 2012.
8. Godlee F. Open letter to Roche about oseltamivir trial data. BMJ 2012;345:e7305.

http://www.pjonline.com/letters/sign_the_all_trials_petition?utm_source=feedburner&utm_medium=twitter&utm_campaign=Feed%3A+PjOnlineLettersFeed+%28PJ+Online+letters+feed%29


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