Why do nine out of ten clinical trials fail, and how can the industry learn from these mistakes?
Clinical trials are notoriously expensive, time-consuming, and often face huge setbacks. In fact, a recent report from the American Society for Biochemistry and Molecular Biology found that as many as 90% of drugs that make it to clinical trial ultimately fail – which is frustrating for sponsors, regulators, and patients.
A successful clinical trial starts at the design stage: rigorously designed and implemented clinical trials are at the heart of delivering innovative new treatments to patients. But how can the clinical development community overcome issues in planning and design trials that deliver results?
What steps can clinical development organizations take to mitigate the risks after the war in Ukraine?
We all hope that the war in Ukraine will end as soon as possible, but there is no denying that its impact will be long-lasting. The clinical development industry in particular will take some time to recover. Although the war is happening in a single country, the effect on clinical development is global. What can sponsors do to keep the development of new treatments moving forward?
Phesi’s reflections of SCOPE 2022
The SCOPE Summit in Orlando, Florida was a hybrid event this year with many people attending in-person, including the Phesi team. It was great to see some familiar faces from the clinical development community without having to shout, “you’re on mute!” through our computer screens. As with every year, the event saw new connections made, thought-provoking breakout sessions, and much buzz surrounding exciting innovations in the clinical trial space.
New diversity data from Phesi shows inclusion of Black and African American patients in clinical trials improving, but Asian, Hispanic and Latino groups significantly and consistently underrepresented
By analyzing protocol design data from Phase 2 and 3 clinical trials conducted in the United States only between year 2010 and 2020, Phesi showed that Asian, Hispanic and Latino, Native Americans and Alaska natives, Native Hawaiians and other Pacific Islander patient subpopulations were all significantly and consistently underrepresented over the decade.
Learning from the past: four pillars of clinical trial design
Although existing problems in clinical trial design have been intensified by COVID-19, the pandemic was not the root cause of these issues. Many trials are at risk due to design issues, resulting in costly protocol amendments and delays. At Phesi, we take a four pillars approach that lets sponsors tackle long-standing problems in trial design.