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Shifting the Paradigm in Personalized Medicine Clinical Trials

Personalized Medicine Clinical Trials

Implementing patient-focused, creative solutions to increase access to novel advanced therapies

Personalized medicine consists of the timely administration of a medical treatment tailored to the individual characteristics of the patient. The successful introduction of autologous cell therapies has addressed unmet medical needs for rare oncology indications which previously had limited (if any) therapeutic options. Well-designed, well-executed clinical trials are critical to the development of these novel treatments, but participation in clinical trials remains low.

Approximately 95% of all oncology patients miss the opportunity to access new therapies through clinical trial participation, affecting the cost of—and access to—new drugs.1

Focusing on the needs of patients and involving them in clinical trial development can help industry and investigators overcome barriers to clinical trial participation and enrollment. Patient-centric solutions are particularly important in rare disease indications, where therapeutic needs must be balanced with quality of life. Minimizing the burden on patients and caregivers and considering beliefs and prejudices that may influence study participation are essential for supporting enrollment.

Biomarker-driven studies face similar enrollment challenges, especially if the target has low prevalence

To address the challenges of patient identification and enrollment, we are working to shift the paradigm of clinical research in the context of personalized medicine. Rather than starting with site selection, our process begins with identifying where eligible patients are located and defining strategies that facilitate clinical trial participation and retention. By meeting patients where they are and understanding what they need, industry and investigators can increase access to novel advanced therapies in clinical trials and beyond.

Read more about creative approaches for increasing enrollment and access to personalized medicine.



1. Unger JM, Cook E, Tai E, Bleyer A. The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies. Am Soc Clin Oncol Educ Book. 2016;35:185-198. doi:10.1200/EDBK_156686