June 9 (UPI) -- Researchers at the University of Pennsylvania have developed a new research design to successfully assess the safety of newly approved and current drugs.
Scientists at the Perelman School of Medicine created the unbiased trend-in-trend design to monitor changes in frequency of outcomes as they relate to changes in an exposure to a drug across groups that adopt the drug at different rates.
The trend-in-trend method can be used to study newly approved drugs or any drug that has a rapidly increasing or rapidly declining trend in consumption.
"Epidemiologic studies can get the wrong answer if there are differences between people who take the drug and people who don't take the drug," Sean Hennessy, a professor of epidemiology in the department of Biostatistics, Epidemiology, & Informatics at Penn and designer of the trend-in-trend concept, said in a press release. "This kind of study is immune to that bias, because it's not comparing users to non-users, it's looking at trends in the frequency of outcome as a function of trends in the frequency of exposure. Even when there are unmeasured factors that are different between groups and those factors affect the outcome -- this study will give the correct answer."
The pace of drug approvals is accelerating as the U.S. Food and Drug Administration, or FDA, faces potential budget cuts by President Donald Trump of 18 percent and calls to roll back regulations, the trend-to-trend concept could alleviate potential problems.
The current FDA review process for new standard drugs is accelerating from 12 months to 10 months, with drugs deemed a priority reviewed even faster at 7.9 months on average.
The United States approves drugs faster than Europe and Canada, sometimes leading to unknown safety issues at the time of approval. One-fifth of all drugs receive a black boxed warning after approval and 4 percent are ultimately withdrawn for safety reasons.
Researchers were able to reproduce the known association between the pain reliever rofecoxib, or Vioxx, and the occurrence of heart attack by using the trend-in-trend method.
The study was published in the July issue of Epidemiology.
