Clinical trial fraud is not an uncommon problem. Though it is difficult to comprehend, it’s something that should not be ignored. Despite the problem, there is some hope. According to industry insiders, regulatory scrutiny is starting to ramp up….
Clinical trial safeguards have significantly improved over the last 50 years. The National Research Act, signed into law in 1974, established Institutional Review Boards (IRBs) to protect patients and increase public trust. In 1991, The Common Rule was adopted,…
Clinical research plays an essential role in identifying and developing new drugs and therapeutics. Yet safety is such a major concern that most Americans say they wouldn’t feel comfortable enrolling. Consider that a recent survey conducted by researchers at…
At the beginning of May, the FDA released updated draft guidance on designing and implementing decentralized clinical trials (DCTs). The draft document fulfills Section 3606(a) of the Food and Drug Omnibus Reform Act, requiring the FDA to issue guidance…
May is National Mystery Month, and although the holiday is technically a commemoration of mystery novels and authors, we thought it might be fun to celebrate in a different way –– by highlighting some of the weirdest, whackiest, and most…
Clinical trials are key to developing new drugs, medical devices, and therapies, but many never even make it off the ground. Consider the fact that 90% of new drug candidates fail and 80% of clinical trials are unable…
Bringing new drugs and compounds to market has always been expensive, but it’s become increasingly so over the last decade. Considering that up to 90% of drug candidates never make it to market, the biotech and pharma industries have…
This year has ushered in the third year of the COVID-19 pandemic. While the virus is something we’re all tired of hearing about, its lingering effects on drug research and development can’t be overstated. PPD, the clinical research branch…
More than 1,200 clinical trials featuring a decentralized or virtual component took place in 2022 –– a 28% increase from a year earlier. Though some trial sites are returning to in-person setups, a recent report from Clinical Trials Arena…