Key Considerations for Overcoming the Complexities of Oncology and Cell Therapy Clinical Trials White Paper

Key considerations for overcoming the complexities of oncology and cell therapy clinical trials 

Beating the odds and getting therapies to the patients that need them requires improved operational efficiency by implementing innovative trial designs, strategies for early-stage decision making and early selection of candidate drugs with a high likelihood of success.

Oncology clinical trials are surging ahead of other therapeutic areas in terms of clinical activity volume, but a higher level of activity does not necessarily translate to a higher success rate. According to data from the U.S. Food and Drug Administration (FDA), oncology drugs have an overall 3.4% approval rate¹, with a vast majority of therapies often failing to gain approval due to drug efficacy or toxicity issues.

This white paper explores key considerations for sponsors navigating these complexities with the support of a dedicated CRO partner. By leveraging proven experience in devising and implementing clinical trial development strategies for complex oncology trials — including cell therapy trials — drug developers gain the perspective needed to successfully navigate:

• Barriers to enrollment and intense competition for qualified sites and patients
• Rapidly changing standards of care and clinical strategies, including an increased acceptance of innovative trial designs and master protocols
• Regulatory and payor requirements that necessitate higher data volume and collection and long-term follow-up

A strong CRO partner — like the PPD™ clinical research business of Thermo Fisher Scientific— empowers drug developers with the end-to-end solutions and capabilities they need to alleviate challenges and realize safer and more cost-effective studies, with speed.

With lives on the line, we offer expertise in managing the operational elements of complex therapeutics. This experience prevents delays in study timelines and contributes to the overall success of the trial — and provides the best opportunity for patients to prolong their lives.

¹ Estimation of clinical trial success rates and related parameters: https://academic.oup.com/biostatistics/article/20/2/273/4817524