A new OSU research study published last week attempts to figure out if scientists are running out of ideas on cardiovascular disease or not. From 1970 to 1999, an impressive and inspiring 57% of big budget clinical trials for drugs treating and preventing heart disease returned positive results. From 2000 to 2012, that number shrank to the considerably less exciting level of only 8%.
Veronica Irvin, an associate professor in OSU’s College of Public Health, was co-author of the study, and she thinks they’ve figured out what happened. And there’s good news in the bad news.
“Some people focus only on positive results,” said Irvin in a press release. “Null outcomes, or results other than what was expected, might be disappointing, but they may inform doctors and patients about which treatments are not likely to be helpful. Publication of null results also prevents the unnecessary replication of the study by other investigators.”
Irvin’s study theorizes that there are two distinct concepts at play in the drastically lower success numbers. The first, as noted above, is that the term “positive” can be a bit loaded. That a clinical trial discovers a drug doesn’t work does not necessarily mean we didn’t learn anything valuable. Indeed sometimes failure can return extremely valuable information.
But the bigger driver of the drop in successful trials is the transition, in 2000, of new federal transparent reporting requirements. The new requirements, among other things, force researchers to register their expected outcomes, in advance of clinical trials, on a government website which tracks the results. Under this new system, when a trial yields an unintended positive outcome, the researchers are restricted from reporting that as the intended successful outcome of the experimentation. This was a frequent occurrence in the past, and not necessarily a bad thing. A positive outcome is a positive outcome, but the new reporting standards ensure accurate and translatable reporting for the public to consume. So in short, the seeming drop off in results of these experiments on human subjects, which are vital to our fight against heart disease, is not itself bad news. It remains unclear if this extends to other fields, though Irvin theorizes it likely will.
“We don’t know if this decrease in positive outcomes also affects drug trials for prevention and treatment of cancer, diabetes, or other diseases, but it would not be surprising because they have the same reporting requirements,” said Irvin.
By Sidney Reilly