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.
According to Victoria DiBiaso, global head of clinical operations strategy and collaboration at Sanofi, “When it comes to improving trials, you have to look at protocol optimization. For us, that is where it all begins.
These best practices can help sponsors and CROs work together seamlessly to prevent and alleviate protocol deviations in their clinical studies keeping development on time and within budget.
Efforts to improve the provider selection/qualification process have improved in recent years, and with the help of digitized, centralized data, additional advancements are on the horizon.