Global Scientists Call For Greater Transparency Of Registered Clinical Trials On Endometriosis

Main Category: Clinical Trials / Drug Trials
Also Included In: Women's Health / Gynecology
Article Date: 05 Mar 2009 - 0:00 PDT

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Human Reproduction [1,4] will publish an article in which leading endometriosis researchers call for all investigators to disclose clinical trial data to the public within 12 months of a trial's completion. According to the authors, such disclosure is the only moral and ethical thing to do - but they also argue that this is the only thing that makes sense scientifically and economically, if scientists are ever to crack the enigma that is currently endometriosis [2].

Professor Guo and his co-authors found that 57 endometriosis-related trials had been registered, amongst which 25 were listed as completed and two as suspended. Yet, only three out of 15 completed phase II/III trials, which evaluated the efficacy of various promising compounds, have published their results. The remaining 12 (80%) of studies have so far not published their findings.

"This lack of transparency will not benefit trial sponsors nor the public, and will ultimately prove detrimental to research efforts attempting to develop more efficacious and safer therapeutics for endometriosis", says Sun-Wei Guo, who is Professor and Director at the Institute of Obstetric and Gynaecologic Research at Shanghai Jiao Tong School of Medicine, and at Renji Hospital in China.

The authors followed up on the 1997 US Congress enacted section 113 of the Food and Drug Administration, which led to the creation of http://www.clinicaltrials.gov as a public depository for information on studies of drugs, including investigation on new treatments for endometriosis.

"The very purpose of mandatory registration is to make results of clinical trials public knowledge, including the good (efficacy) and the bad (lack of efficacy and/or adverse effects) results, so that everyone will benefit from hard-earned lessons so that positive results are built upon scientifically, and so that no one repeats others' mistakes and miscalculations. Unless there is complete transparency some invaluable insight would be forever lost, along with their investment, to the detriment of the cause to uncover better therapeutics for endometriosis - and other conditions," says Professor Guo.

World Endometriosis Society [3] president and co-author, Professor Johannes Evers of Maastricht University in The Netherlands, expresses his concern about non-publication of clinical trial results. "As clinicians and as scientists we must never lose sight of those brave women, who have placed themselves purposefully at risk by volunteering for clinical trials in the hope that a better treatment for endometriosis might be discovered. We owe it to these volunteers to publish results of all trials, so that their participation results in knowledge that will be available to future patients and investigators to improve patient care," says Professor Evers.

[1] A call for more transparency of registered clinical trials on endometriosis. Sun-Wei Guo, Lone Hummelshoj, David L Olive, Serdar E Bulun, Thomas M D'Hooghe, and Johannes LH Evers. Human Reproduction, 2009 doi:10.1093/humrep/dep045

[2] Endometriosis is a condition where tissue, similar to the lining of the uterus, is found in other areas of the body (mainly in the abdominal cavity). This tissue responds to a woman's hormonal cycle. This abnormal tissue can give rise to nodules, lesions, cysts in the ovaries, and adhesions, resulting in inflammation, pain and infertility. Endometriosis is predominantly found in women of reproductive age from all ethnic and social groups, and the consequence of the disease has a major impact on quality of life for the estimated 100 million sufferers worldwide. Treatments include painkillers, hormonal treatments (often with brutal side effects), surgery, and hysterectomy. None of these treatments guarantee relief, and there is no known cure (http://www.endometriosisfoundation.org/endometriosis.php). It is estimated that endometriosis cost the US economy US$22 billion in 2002 alone. There is as yet no comparable data in Europe.

[3] The World Endometriosis Society is an international organisation, founded in 1998, to promote the exchange of clinical experience, scientific thought, and investigation among gynaecologists, endocrinologists, scientists, biologists and other qualified individuals interested in advancing the field of endometriosis. Through its e-Journal and the World Congresses on Endometriosis WES encourages and support collaboration among national and international societies and individuals interested in endometriosis (http://www.endometriosis.ca)

[4] Human Reproduction is a monthly journal of the European Society of Human Reproduction and Embryology (ESHRE), and is published by Oxford Journals, a division of Oxford University Press.

World Endometriosis Society

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