ClinicalTrials.gov
Clinical Trials: Sharing of Data and Living Up to Our End of the Bargain
Posted on by Drs. Kathy L. Hudson and Francis S. Collins
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Today we took a huge step forward in our efforts to make sure that data from biomedical research is shared widely and rapidly. The NIH, in collaboration with our fine colleagues at the U.S. Food and Drug Administration (FDA), and with the valuable input from scientists, patients and other members of the public, has announced the HHS regulation and NIH policy to ensure that information about clinical trials is widely shared. In this blog I want to talk about what this will mean for patients, providers, and researchers. I also want to reflect a bit on how the new regulation and policy fit into our overall efforts to improve clinical trials and data sharing.
Clinical trials are essential for the translation of research advances to new approaches to prevention and treatment. Volunteers who take part in clinical trials often do so with no assurance of personal benefit, but with the expectation that their involvement will add to the growing body of knowledge about health and disease, and thus may help others someday. For that to be realized, all trial results information needs to be publicly reported in a timely fashion—and yet we know that doesn’t always happen. Today’s announcements aim to change that. The HHS regulation issued today, called a “final rule”, describes requirements for registering certain clinical trials and submitting summary results information from these trials to ClinicalTrials.gov, a database managed by NIH’s National Library of Medicine (NLM).
Honoring Our Promise: Clinical Trial Data Sharing
Posted on by Drs. Kathy L. Hudson and Francis S. Collins
When people enroll in clinical trials to test new drugs, devices, or other interventions, they’re often informed that such research may not benefit them directly. But they’re also told what’s learned in those clinical trials may help others, both now and in the future. To honor these participants’ selfless commitment to advancing biomedical science, researchers have an ethical obligation to share the results of clinical trials in a swift and transparent manner.
But that’s not the only reason why sharing data from clinical trials is so important. Prompt dissemination of clinical trial results is essential for guiding future research. Furthermore, resources can be wasted and people may even stand to be harmed if the results of clinical trials are not fully disclosed in a timely manner. Without access to complete information about previous clinical trials—including data that are negative or inconclusive, researchers may launch similar studies that put participants at needless risk or expose them to ineffective interventions. And, if conclusions are distorted by failure to report results, incomplete knowledge can eventually make its way into clinical guidelines and, thereby, affect the care of a great many patients [1].
Clinical Studies in Your Own Backyard
Posted on by Dr. Francis Collins
Map of clinical trials in the U.S. as of Feb. 7, 2013
Source: ClinicalTrials.gov
NIH conducts clinical research studies for many diseases and conditions, including cancer, Alzheimer’s disease, allergy and infectious diseases, and neurological disorders. What’s more, this work is being carried out in every state of the nation, as you can see from this interactive map showing clinical studies supported by NIH and others.
Before you start exploring this map, let’s take a moment to review the basics. A clinical study involves research using human volunteers that is intended to add to medical knowledge. One common type of clinical study, called a clinical research trial, looks at the safety and effectiveness of new ways to prevent, detect, or treat diseases. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.
If you’re interested in taking part in a clinical study, a terrific place to start is ClinicalTrials.gov, which is a service of NIH. This searchable database lists more than 139,000 federally and privately funded clinical studies in the United States, as well as around the world. For each study, the database provides information on the purpose of the research, who may participate, where the study is being conducted, and who to call or e-mail for more details. To help you in your quest, we’ve pulled together some handy search tips, along with some real-life stories from both volunteers and researchers.
Finally, please keep in mind that ClinicalTrials.gov is just a starting point. Any information that you find there should be used conjunction with advice from your doctor or another health care professional.
