Clinical Trials – the path to new drugs and device approval by testing them on humans. As I’ve become increasingly involved in the research side of breast cancer advocacy, I’m often called upon to explain trials – what they are, how they work, and why they are necessary. It is, in my opinion, a critical roll played by advocates who advise researchers through the trial process.
Define. Recruit. Support. Disseminate.
From the research side, I hear concerns about filling trials, the obstacles to recruiting patients and the number of trials that can’t be completed because there simply aren’t enough participants. Without these trials being filled, drugs and devices simply can’t be approved – so filling them matters, and why I see it as my responsibility to encourage patients to be aware of and consider participation in trials.
Our researchers have responsibilities in the process as well – among them proper disclosure of risks and benefits to and the protection of patients. There is, I believe, another obligation – to add to our human knowledge base. So my frustration flared when I read Data Dump: US Trials Often Fail to Report Results. The upshot is this:
When assessing clinical trials conducted in the US between 2007 and 2010 (4347 trials in all), the study’s author found that only 36% of results reported within two years of completion, and 34% of trials never reported or publishes data. In fact, there were no model institutions from which to even draw best practices. This despite federal requirements that trial data be reported within 12 months of the end of each trial.
While there is no indication in the study as to whether unreported trials produced “positive” or “negative” results, it is worth noting that “positive” results are published as part of a path to approval by the FDA, leaving a greater pool of “negative” results to be left unreported.
Why is this an issue? Well, here’s my thinking, and I’m sure others have their own concerns.
- Patients deserve better. We offer up our very bodies, take risks of and suffer from side effects, further progression or secondary disease, and put our very lives on the line. I believe we deserve to know the outcomes, to know that we’ve made a difference. This may be especially true when drugs don’t move on in the process! Trial participants are not guinea pigs, and secrets don’t serve us. We and our loved ones should know about the difference we’ve made, even if it’s knowing what doesn’t work.
- Knowledge is power, they say. I understand the reluctance in publishing “failed” or “negative” data. I’m sure every scientist and researcher wants to share their successes – that’s human nature, especially in a intense and sometimes cut-throat field. But the sharing of knowledge, adding to the world of understanding, is the very purpose of scientific inquiry. And repeating our mistakes because they are hidden in some lab is unconscionable! (P.S. Are you aware of the The Journal of Negative Results in BioMedicine? Yea them!)
- Often times, we’ve paid for it. A great deal of research in the US is funding by government, especially by the Feds. As such, we as taxpayers have paid researchers to conduct their trials. And unlike state secrets, which we also pay for, sharing this information is good for humanity. In my humble opinion, there should be some measure of accountability to taxpayers.
I understand publication of negative data is time consuming, that researchers are at risk of damaging future funding, that moving on to the next thing is compelling, and that journals are not eager to publish. However, as patients, trial “subjects” and advocates, we must push for more! We have quite a bit of skin in the game, and systems rarely change on their own.
When asked about the challenges of developing an incandescent lightbulb, Edison said something along the lines of “I have not failed. I have discovered 1000 ways that won’t work.” Such is the life of an innovator. Science progresses thanks to both successes and mistakes. We are all eager to improve the pace of identifying new therapies, be it cancer or any other disease, and get these innovations to clinics where lives are improved and extended. Edison was fastidious, and likely did not make the same “mistake” twice – when people are offering themselves up for clinical trials, don’t they deserve the same?
P.S. Thanks to AnneMarie Ciccarella (blogging at Chemo Brain Fog) for bringing the article to my attention and to Mary Pat Barry for reminding me not to get my feathers too ruffled over this one! XOX