Living With Cancer: A Broken Covenant With Patients by Susan Gubar, NY Times Well Section published January 15, 2016
A comment from Dr. Mark Lewis, CKN Social Media Editor
Participation in a clinical trial is, ideally, a two-way street. The patient potentially stands to gain therapeutic benefit while the researchers learn about the efficacy and toxicity of the intervention under study. This post on the New York Times Well blog highlights concern about a lack of transparency in reporting the outcomes of trials, even if they generated negative results or, to quote Susan Gubar, “adverse consequences.”
This sentiment echoes a longstanding concern in the medical community about publication bias, meaning that successful outcomes are far more likely to be shared in the literature than null results. The problem is a tricky one because, by definition, the result of an experiment cannot be known until the experiment is conducted, so scientists cannot know at the outset which hypothesis will be affirmed, no matter how rigorously their trials are designed.
That said, efforts are being made at course correction. Since 2004, the editors of major medical journals, including the New England Journal of Medicine, Lancet, and the Journal of the American Medical Association, have refused to publish the results of trials sponsored by pharmaceutical companies unless the research was registered in a public database like clinicaltrials.gov from the beginning (http://www.smh.com.au/articles/2004/09/09/1094530773888.html).
Meanwhile, Dr. Ben Goldacre, a passionate advocate for rigor and rationality in clinical trial design, has spearheaded the AllTrials.net project to promote open data in clinical research. Their petition reads as follows:
“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.”
More recently, Dr. Goldcare launched compare-trials.org which holds researchers accountable for reporting outcomes by comparing the published results vs. the pre-specified endpoints.
Finally, the cooperative groups that organize academicians around research goals are increasingly involving patients and their advocates in trial design, including mechanisms to report outcomes to the patients who participate, which should address the concerns so eloquently voiced by Susan Gubar in her blog post.
A comment from Dr. Robin McGee, Patient Advocacy Editor
I can speak to this issue on two fronts. In addition to being a cancer survivor and patient advocate, I also have a PhD in clinical research methods. So I am very well acquainted with the need for rigorous research around clinical trials. I understand fully the need to explore individual difference factors in treatment efficacy studies. The positive-results-publication bias described by Dr. Lewis is endemic to all clinical research. I get all that. I know that researchers are often so busy seeking the holy grail that they forget to document where they have been.
My patient perspective is not so dispassionate. I salute Susan Gubar for her poignant and outraged commentary on her discovery that the results of negative clinical trials are suppressed or simply ignored. Big Pharma and Big Universities do not register their negative results on the required website, and the government does not regulate these omissions. Although academic journals attempt to police such registration, by definition most of those applying to journals are those trials with positive results. So no one is watching the watchmen.
Paraphrasing Dr. Goldacre, as cited in Mark Lewis’ editorial , failure to adequately document negative clinical trials is irresponsible, inefficient, and morally dishonorable The recent failure of Pharmaceutical giant GalaxoSmithKline’s failure to disclose the potential harms of their diabetes drug Aventia should teach us that Big Pharma will not police itself when profits are at stake. It is shocking, however, to learn that public institutions like universities do not take this responsibility seriously either. Vast amounts of taxpayer’s money is invested in government funded trials, and accountability and transparency must be demanded. But the obligation to register trial results must be sought not just because of the money invested – but because of the blood, sweat, and tears that patients invested.
Negative Cancer Trials: Short-term Whimper, Long-Term Bang “Negative trials aren’t scientific failures,” said Joseph Unger, PhD, a SWOG statistician based at the Fred Hutchinson Cancer Research Center and the lead author of the study. “We found that they have a positive, lasting impact on cancer research.”