Paper Review – ‘A call for more transparency of registered clinical trials on endometriosis’ PART ONE

In Volume 1, No. 1, 2009 edition of the medical journal Human Reproduction a debate paper debuted titled: A call for more transparency of registered clinical trials on endometriosis. This was published by Sun-Wei Gou of Renji Hospital, and the institute of Obstetric and Gynecological Research; Lone Hummelshoj – Secretary General of the World Endometriosis Society; David Olive of the Wisconsin Fertility Institute; Serder E. Bulun of the Division of Reproductive Biology Research, Department of Obstetrics and Gynecology at Nortwestern University in Chicago, IL; Thomas M. D’Hooghe of the Department of Obstetrics and Gynaecology, Leuven Fertility Center in Belguim; and Johannes L.H. Evers of the Division of Reproductive Medicince, Research Institute GROW at Maastricht University Medical Center in the Netherlands.

I was searching the databases one day when this article appeared. Thankfully, Sun-Wei Gou was generous enough to provide a copy of the piece for me to review as my database did not allow me access. But why did this article catch my interest?

If you are a regular reader, or were especially around in March, then you will know how adamant I, and other endometriosis bloggers, have been about the need for clear transparency when it comes to endometriosis drug trials. We spoke about this in length when a certain endometriosis organization refused to disclose their donor list, or release their research findings – even to the very participants they sought to recruit for their studies. Nevertheless, this review came across my radar, and of course I had to review it.

While reading this debate piece, during the researcher’s opening statements, the following section of text grabbed me: “…more efficacious therapeutics, preferably with improved safety and cost profiles are sorely needed (Nothnick and D’Hooghe, 2003; Fedele and Berlanda, 2004). (p. 1)

In their opening, the researchers discuss how the current medicinal management in use for endometriosis is under par for patients’ pain symptoms, and how the current – and popular use – of continuous use birth control pills is not an effective treatment for endometriosis or endometriosis pain.

Could gynecologists be referring patients to continuous use birth control treatment, and other treatments, because of the lack of new treatment options? This could very well be the case. But we must ask why, with all the money being funneled into drug research trials why has there yet to be a new drug breakthrough for endometriosis. The researchers post this question, as well.

According to the review, because of the secrecy surrounding clinical trials, the US Congress became involved in an effort to regulate and draw these billion dollar funnel holes into the light. In November 1997, Congress enacted Section 113 of the Food and Drug Administration Modernization Act and this created the website ClinicalTrials.gov, a website where researchers are encouraged to list drug trials. Some medical journals followed along and announced that they would not publish research that had not been previously registered with website such as ClinicalTrials.gov. Then ten years later the World Health Organization follows with their website. Since then, Congress has revised the parameters in which ClinicalTrials.gov operates within the scope of the FDA to improve safety measures for drug and medical device trials.

According to the writers of this article, the importance of ClinicalTrials.gov, and sites like it are that the:

… data will be available to the public within 12 months of trial completion or within 30 days of FDA approval (or clearance) of a new drug, biological or device. Clearly, the pressure is mounting for more transparency of all clinical trials, to the benefit of those who research disease pathogenesis, and ultimately to those who suffer from conditions such as endometriosis. (p. 2)

As medical bloggers, patients, activists, etc, we can take an active part in these clinical trials by watching them from formation to completion. We can make these drug companies accountable. Because, as I will get to later in this review, the alarming fact is that a large portion of these clinical trials – these expensive clinical trials – are seen through to completion with no research date being published for peer or public review. I will get into that in depth later in the review, but for now, let’s discuss current endometriosis research numbers on ClinicalTrial.gov.

The researchers conducted their own search for ‘endometriosis’ on the website at the time of writing the review, but I wanted to do a more updated search. Mine was conducted on November 5, 2009 in the afternoon. My search for the term ‘endometriosis’ pulled 73 studies, 24 of which were open. The rest were either completed or not actively recruiting. Out of those 24, at the time, there were only 2 that pertained to a particular endometriosis drug or treatment.

PART TWO will continue next week…

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2 responses to “Paper Review – ‘A call for more transparency of registered clinical trials on endometriosis’ PART ONE

  1. Endochick,

    Where shall I start? It saddens me that there has been so much money spent (by that I mean wasted) and so much secrecy over the years… only for things to be where they are at now (i.e. treatment options for endometriosis that are not much different now than they were many years back).

    There is clearly a need for more transparency in medical research studies. This applies to far more conditions than just endo. There is plenty of talk about raising money for research, the need for research, etc. However, here we are in 2009 and women are really suffering… and often getting sub-standard treatment for this serious illness.

    The fact that a certain endometriosis organization refused to disclose their donor list or release their research findings – even to the very participants they sought to recruit for their studies is pretty telling, isn’t it? Sad too.

    I have lived with endometriosis for 27 years now. The sad lack of progress overall is discouraging.

    The numbers you closed with are pretty telling, aren’t they?

    I look forward to the next part of your review.

    Jeanne

  2. alllistoctober2ansi

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