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Patient input leads to study design change reducing patient burden


“As part of our feasibility processes for a large breast cancer oncology clinical program, our study teams used parts (elements) of the ‘P-PET toolkit‘ to engage with patient advisory groups (patients, survivors, and co-survivors) about a number of planned clinical trial designs. Early draft study protocols (prior to receiving patient advisor feedback) required that all patients undergo a pre-screening biopsy in order to qualify for study participation. The unanimous feedback from the patient advisors reflected in the patient panel read-out reports helped study teams to better understand the impact and burden of this ‘additional’ invasive procedure as well as its impact on a patient’s desire or willingness to consider participation in a clinical trial. The clinical program directors were able to document the rationale for the need to modify this study requirement (inclusion criteria) across all related studies within the clinical development program, whenever possible.

As a result, the study teams made broad protocol design modifications allowing patients willing to share their diagnostic samples and where possible to substitute required pre-screening biopsies with the flexible option of using their ‘archived scientifically optimal diagnostic biopsy samples.’

This new study inclusion option designed to reduce patient burden, requires that patients have access and be willing to share their archived tumor samples. Patient advisors clearly indicated that this type of flexibility would bring them closer to being shared decision makers in their own health care.”

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