[Ip-health] Support Transparency in Clinical Trials
gregg.gonsalves at yale.edu
Thu Jul 9 08:38:07 PDT 2015
I am writing to ask you to pledge support for a campaign that is transforming medicine, one that will benefit patients everywhere– AllTrials (AllTrials.net).
AllTrials has united patients and doctors, professional societies and patient groups to tackle the pressing problem of missing clinical trial data. Estimates show that 50 percent of all clinical trials have never reported their results, and many have never even been registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for better medicine, and the betrayal of patients who volunteered for those trials.
That’s why organizations including the Yale Global Health Justice Partnership, the American Medical Women’s Association, the American College of Physicians, and the Boston University School of Public Health have just pledged their support for the campaign by signing the AllTrials petition.
AllTrials has helped to change the law in Europe and in Canada. Indeed, support from patient groups proved critical to shaping public and political understanding of the issue.
On Tuesday, July 21st, AllTrials will launch in the USA and, in advance of that day, we really hope you will add your voice to the growing call for clinical trials transparency.
You can endorse AllTrials campaign with an email to alltrials at senseaboutscienceusa.org (cc-ing trevor at senseaboutscienceusa.org and jcockerill at senseaboutscience.org).
Please try to get your endorsement in by Monday, July 20th, as AllTrials can then add your organization’s name to the press release sent out that afternoon. The official launch is the next day and you can get late endorsements in by noon on July 21st.
· Only about half of all clinical trials ever conducted have reported results, and thousands more have never even been registered. AllTrials is a campaign to end this serious problem.
· Information on what was done and what was found in these trials could be lost forever, as papers perish, floppy disks, CDs and hard drives fail, keys are lost and researchers who know about the trials retire.
· This means that doctors and researchers do not have half of the data that could be available to them, leading to incomplete treatment decisions, missed opportunities for better medicine, and trials being needlessly repeated.
• Worst of all this is a terrible betrayal of trust of the patients who take part in clinical trials
· The AllTrials campaign is calling for every clinical trial, past and present, to be registered and their results reported.
· Registering and reporting results in a publicly accessible database like the National Institute of Health’s clinicaltrials.gov means that people will know the trial has taken place and the results are available to researchers and doctors.
• We’re not advocating for the sharing of any individual patient data, only findings from the trial.
Frequently asked questions
What does joining the AllTrials campaign mean?
It means you publicly support the aims of the campaign. We are calling for everybody who has a role in clinical trials (funders of research, pharmaceutical companies, researchers, regulators, policy makers, journals etc) to take responsibility, and make a commitment to do what they can to change the situation.
How do I join?
Please send your logo to alltrials at senseaboutscience.org and we will add you to our supporter’s page of the Alltrials website. Please also send a short statement to explain why increased clinical trials transparency will matter to your organisation.
Aren’t there are already laws to deal with this?
There is no global law on clinical trial reporting. A small number of countries have laws about registering clinical trials carried out in that country; an even smaller number have laws about reporting results from trials; most do not.
Where laws do exist they are not being enforced. In the US, for example, the FDA Amendment Act 2007 requires that clinical trials carried out in the US on currently licensed drugs after 2009 should be registered on clinicaltrials.gov and report results within a year of their end. The law gives the FDA power to fine researchers who do not comply. An independent audit in 2012 found that only 22 percent of trials complied with the law. Nevertheless no fine has ever been levied against any company or researcher.
Global Health Justice Partnership
Yale Law School-Yale School of Public Health
P.O. Box 208215
New Haven, CT 06520-8215
Email: gregg.gonsalves at yale.edu
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