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For Release: May 1, 2013
Contact: Annmarie Christensen, Dartmouth Institute for Health Policy & Clinical Practice, Annmarie.Christensen@dartmouth.edu, +1 603-653-0897
Sile Lane, Sense About Science, slane@senseaboutscience.org, +44(0)207 490 9590

AllTrials campaign launched in US
Dartmouth's Geisel School of Medicine to lead the US campaign for all clinical trials to be registered and results reported
Campaign now spreading globally as patients and researchers join the call for openness about research results

Hanover, N.H.—Today the AllTrials Campaign announced that Dartmouth's Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice signed on to be the first US academic center in this important campaign and will take the lead in urging all medical schools and patient advocacy groups in the US to add their voices at AllTrials.net.[1]

The AllTrials campaign, which calls for all clinical trials to be registered and results reported, was launched in the United Kingdom in January 2013. Some 48,000 people and more than 250 organizations, including more than 100 patient advocacy groups, have joined. In February 2013, GSK became the first pharmaceutical company to join the campaign[2].

At the launch of the campaign in the US, the National Breast Cancer Coalition (NBCC) joined Dartmouth's call for patients, researchers and physicians to join. NBCC is the grassroots advocacy organization that seeks to improve public policies surrounding breast cancer research, diagnosis and treatment. NBCC said today that patients who have participated in clinical trials expect findings generated by their participation to be shared with researchers to advance the field.

Dr. Elliott S. Fisher, Director, Dartmouth Institute for Health Policy & Clinical Practice:
"The Geisel School of Medicine at Dartmouth and the Dartmouth Institute for Health Policy & Clinical Practice are proud to lead the AllTrials campaign in the US. Dartmouth is committed to helping doctors, patients and the public make wise decisions about health and healthcare. Biased, selective or non-publication of clinical trials undermines our ability to understand and communicate the effects of tests and treatments—and it violates the public trust. We urge academic medical centers throughout the world to join AllTrials' call for the registration and timely full publication of all clinical trial protocols, methods and results."

Annette Bar-Cohen, Executive Director, Center for Advocacy Training, National Breast Cancer Coalition:
"NBCC advocates have been involved in many aspects of clinical trials—from participating as patients to reviewing grant proposals for trials, to representing NBCC on trial protocol committees and data and safety monitoring boards. We are especially interested in making sure that trials ask significant questions that will propel the field forward, that trials are well designed with meaningful outcomes, and that results are widely disseminated and inform the field. This is why it is important that all trials be registered and all results be publicly shared."

Tracey Brown, Sense About Science, co-founder of the AllTrials campaign:
"We are delighted that the Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice have announced they will lead the AllTrials campaign in the United States. This is a good moment for organizations across the US and the world to add their voice as the AllTrials campaign has started to take off internationally."

Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign:
"Doctors and patients need the results of clinical trials to make informed decisions about which treatment is best. When trial results are withheld, we cannot practice medicine safely and effectively. This huge international problem has been well documented in the medical and academic literature for three decades now, but with little forward movement. It started as a "cultural blind spot," when people didn't realize how important it was to pool all the data: we no longer have that excuse. The time is now for everyone in medicine—patients, doctors, researchers and industry—to stand up and fix this problem for good. We need all the results, of all the trials that have been done, on all the treatments currently in use, to be made publicly available."

Sir Iain Chalmers, James Lind Alliance and co-founder of the AllTrials campaign:
"Clinical science is an international endeavor. Patients who contribute to clinical science all over the world know that they are helping to increase knowledge relevant to their needs and the needs of hundreds and thousands with similar needs. Failure to report the results of research to which these volunteers have contributed is unethical, unscientific and a waste of precious research resources. The voices of the many patient groups that have demanded registration and publication of all clinical trials are the most important voices in the AllTrials.net campaign. Research sponsors and researchers who ignore the calls for full transparency of the results of all clinical trials made by participants in trials risk ending up, justifiably, losing the trust between patients and researchers upon which clinical science depends."

Organizations across the United States have added their voice to the campaign:

American Medical Students Association:
"AMSA strongly endorses the AllTrials campaign to make available all clinical trial results for all treatments being currently used. For over a decade, AMSA has been advocating for medical education and practice that is evidence-based, rather than marketing based. Evidence-based medicine, however, is not possible with the continued allowance of pharmaceutical and device industries to hold hostage key clinical trials that may impact a prescriber's decision-making ability. AMSA signs onto the AllTrials petition as a crucial step to ensure that the lives of our patients and the integrity of our profession are protected."

Society for Clinical Trials:
"Transparency of clinical trial study design and results is important to researchers, physicians and the public. In order to design the highest quality and most ethical clinical trials in the future, we need to learn from and incorporate all past experience. The Society for Clinical Trials has signed this petition because each study participant deserves to have the data he or she contributed yield the maximum benefit to society. These and other topics are discussed during our annual May meetings and in our Journal. See www.sctweb.org for details of both."

Peg Ford, Ovarian Cancer Alliance of San Diego:
"The importance of listing ALL clinical trials results is so vital to saving lives and patient care. As a Research Cancer Advocate, as well as an ovarian cancer survivor, the only way we can get a screening test for the early detection of the most lethal gynecologic cancer—ovarian cancer, is through research and clinical trials. We in the patient community cannot wait for research to be delayed from the unsuccessful trials not being disclosed and/or researchers to discover prior findings were flawed after they have attempted to move the research forwarded. Please remember human lives are at stake here and participate in the proper transparency as a fellow human being."

The Lupus Research Institute:
"The Lupus Research Institute and our New York affiliate, the SLE Lupus Foundation, are pleased to support the AllTrials petition for transparency in clinical trials. The LRI is the leading private funder of novel research in the autoimmune disease systemic lupus erythematosus and a strong advocate for patient participation in clinical trials. With a desperate need for new treatments for lupus and insufficient enrollment in clinical trials testing new drugs, access to trials results is extremely important for our community."

For more information contact:

Annmarie Christensen, Dartmouth Institute for Health Policy & Clinical Practice, Annmarie.Christensen@dartmouth.edu, +1 603-653-0897

Sile Lane, Sense About Science, slane@senseaboutscience.org, +44(0)207 490 9590


Notes:

  1. The AllTrials campaign was launched in the UK on 9th January 2013 by BMJ, the Oxford Centre for Evidence-based Medicine, Bad Science, Sense About Science, the James Lind Initiative and the Cochrane Collaboration. The campaign petition says that it's time all clinical trial results are reported. Patients, researchers, pharmacists, doctors and regulators everywhere will benefit from publication of clinical trial results. Wherever you are in the world please sign the petition:

    Thousands of clinical trials have not reported their results; some have not 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 good medicine, and trials being repeated.

    All trials past and present should be registered, and the full methods and the results reported.

    We call on governments, regulators and research bodies to implement measures to achieve this.

  2. GSK joined the campaign on 5th February 2013 and committed to making public clinical study reports for all their approved medicines dating back to the formation of GSK in 2000. Their full statement can be found here.

The Geisel School of Medicine at Dartmouth, founded in 1797, strives to improve the lives of the communities it serves through excellence in learning, discovery, and healing. The nation's fourth-oldest medical school, the Geisel School of Medicine has been home to many firsts in medical education, research and practice, including the discovery of the mechanism for how light resets biological clocks, creating the first multispecialty intensive care unit, the first comprehensive examination of U.S. health care variations (The Dartmouth Atlas), and helping establish the first Center for Health Care Delivery Science, which launched in 2010. As one of America's top medical schools, Dartmouth's Geisel School of Medicine is committed to training new generations of diverse health care leaders who will help solve our most vexing challenges in health care.

The Dartmouth Institute for Health Policy & Clinical Practice was founded in 1988 by Dr. John E. Wennberg as the Center for the Evaluative Clinical Sciences (CECS). Among its 25 years of accomplishments, it has established a new discipline and educational focus in the Evaluative Clinical Sciences, introduced and advanced the concept of shared decision-making for patients, demonstrated unwarranted variation in the practice and outcomes of medical treatment, developed the first comprehensive examination of US health care variations (The Dartmouth Atlas), and shown that more health care is not necessarily better care.

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