‘Therapies that hold immense promise may never see the light of day’

We caught up with Dr. O’Neal to discuss the telltale signs of trouble in clinical trials that sponsors can pick up on early and how they can address these issues swiftly to keep their trials on track and effective drugs within reach for patients.

BPR: What are common challenges drug developers face during clinical trials?  

During clinical trials, drug developers often face operational and data-related challenges that can significantly impact whether trials are successful. Drug development is incredibly complex, particularly in late-stage clinical trials​ in areas such as oncology, musculoskeletal disease, and Alzheimer’s, where imaging is heavily relied on and creates additional layers of complexity. Challenges include flawed study designs, inadequate endpoints, low-quality data, and poor site management, leading to increased costs and barriers to patients receiving access to these promising and potentially life-saving therapies. 

BPR: How do these challenges impact the likelihood of achieving regulatory approval?   

These operational, data management, and image acquisition challenges put many promising therapies at risk of never receiving regulatory approval, as drug efficacy alone is not always an accurate predictor of success in clinical trials. Ninety percent of drug candidates fail during clinical trials, which cannot always be attributed to a lack of efficacy; some therapies that hold immense promise for patients may never see the light of day. Recurring problems like inconsistent assessments of data or imaging can cause headaches for drug developers and contract research organizations (CROs) and exacerbate other issues like high adjudication rates and site-central discordance, decreasing the likelihood of regulatory approval. 

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