A new research letter, published today in the Journal of the American Medical Association (JAMA) brings to light a significant change in funding for new clinical trials. How will these changes impact new medical treatments, and advances in medicine, over time?
Clinical Trial Funding
According to the National Heart, Lung, and Blood Institute, Clinical trials are, ” …research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.” Clinical trials are conducted on human patients, rather than mice, or cells in a lab, so can give a clearer view of a treatment’s results and/or effectiveness for people.
Clinical trials may receive funding from the medical industry (for example: A pharmaceutical company is in the final stages of testing the safety of a new blood-pressure drug, and needs a clinical trial to get approval to market the drug), other groups (such as a non-profit with a particular interest in treatment advances for a certain disease, funding a clinical trial for a new treatment for that disease), and the NIH. The National Institutes of Health funds clinical trials that affect patient health in general, without an emphasis on particular drugs or diseases, and so fund a wider variety of trials.
New Research: NIH Funding Down
Decoded Science spoke with researcher Stephan Ehrhardt, MD, PhD, Associate Professor in the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health about the new research, published in JAMA today. According to Dr.Ehrhardt’s calculations, NIH funded trials are down and trials funded by other US Agencies are slightly up, while trials funded by Industry and Other are both strikingly increased. What does this mean for the credibility of these trials?
Dr. Ehrhardt tells us, “The concern is that industry funds particular types of trials – trials that test their own products. Independent, academic investigators are often trying to answer different questions. Such as: What is the comparative effectiveness of two or three different drugs. Or: How can a lifestyle intervention like a diet or an exercise regimen reduce blood pressure in comparison to a commonly prescribed drug. Industry would never fund such trials. And when they test their products, they might be inclined to show how good they are. So, these trials are not generally suspect but one has to look carefully if, for example, the outcomes are meaningful to patients and public health.
Decoded Science: Since Industry tends to test their own products, and the NIH tends to test procedures or treatments that aren’t for any financial interest on the part of the government, do you think the drop in NIH-funded studies will lead to a drop in medical advances that aren’t directly linked to a company’s new product?
Dr. Ehrhardt: We believe this is a concern. Again, in particular when it comes to interventions that are not interesting to industry.
What Does Reduced NIH Funding Mean For Public Health?
It could mean a reduction in general public health trials, and an increase in trials to answer questions for Industry and special-interest groups alone.
Dr. Ehrhardt explains: The NIH is the largest funder of independent research in the world. NIH funds, among other studies, trials that answer questions that are important for public health. We can’t expect industry to fund these trials because they need to watch their bottom-line. A potential and growing imbalance in clinical trial funding (less NIH and more industry) might be a concern for improving the health of the public.