When it comes to clinical trials, the pharmaceutical industry still has a patient diversity problem. The face of patients in clinical trials is not representative of the face of America.
As one expert said, though there are many reasons to praise clinical trials for their contributions to drug development, they may not always be the best method to answer some of the most important biosimilar questions we have today.
As clinical trials become more complex in terms of regulatory compliance and scope of study, it is more important than ever that procurement teams develop a clear understanding of the various cost drivers related to operating a clinical trial.
HIV drug developers have a whole new set of challenges, including making the regimens simpler better tolerated. In addition, since today’s patients can access these medicines through pharmacies, they no longer have the incentive to take part in clinical studies.
Bari Kowal, VP and head of global clinical operations at Regeneron, says sponsors and CROs must partner to make clinical trial execution more efficient and cost-effective.
Three years ago, AbbVie decided to stop talking about using digital technologies in clinical trials and start actually using them. The company then began deploying wearables in three clinical trials.
Insights for the simple things you can do to mitigate the most common patient enrollment problems that every study (with very few exceptions) will inevitably face.
The primary benefit of master trial protocols for drug companies is the ability to concurrently evaluate multiple studies that may have different objectives, saving both time and money.
“A partnering deal with a bigger pharma company would certainly help us through [the Phase 3] process,” explains Jeff Davidson, CEO of Keystone Nano, a company that develops nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact.
Evofem Biosciences is on the cusp of releasing a revolutionary birth control product. But before the FDA gives its approval, this small biopharma has to navigate two very different clinical trials.