Abstract P4-18-03: Measuring what is important to patients in clinical trials: Hearing the patient's voice

Patients who participate in clinical trials are important to clinical research and contribute to the advancement of medical discoveries. However, typical clinical trials do not always capture information that is important to patients: how they feel, function and survive. The only way to accurately measure how a patient feels or functions is to ask them. This can be done through the administration of health related questionnaires that are filled out by the patient without interpretation from anyone else; these are referred to as Patient Reported Outcomes (PROs). Although, PRO assessments have been used in clinical trials for the past 30 years through the collection of global quality of life (QOL) and later health related QOL (HR-QOL) measurements, the information has been too broad and has not been precise enough to use in drug approvals, descriptive drug label information or to inform other patients. There is an effort to change the paradigm of PRO assessment to measure the information most relevant to patients in clinical trials. This includes measuring treatment toxicity, symptom burden and physical function. This is relevant information that other patients want to know about a specific treatment for a specific disease to help them in their treatment decision making. The voice of the patient is critical to assess these items, through PRO measurements. In order to ensure that PRO questionnaires are filled out during a clinical trial, there are ways to make them more acceptable to patients by involving patients in their development (what questions are asked/how many questions are asked/when they are given to patients/how they are given to patients). Patients can inform study teams on the acceptability, understandability and relevance of the questions being asked. Patients can be a key contributor to clinical trial development by identifying the questions that are most important to them and the best way to ask these questions during a clinical trial. Patient advocacy and educational organizations like Cancer Information & Support Network (CISN) are advocating for changes in PRO collection in clinical trials. Based on information collected from many survivors, caregivers and advocates, a patient-centric clinical trial development model will be proposed. The model includes the involvement of patients as key stakeholders early in clinical trial development to incorporate PROs into clinical trials that are acceptable for patients to complete and the outcomes are meaningful and matter to future patients. Citation Format: Spears PA, Devine P, Finestone S. Measuring what is important to patients in clinical trials: Hearing the patient9s voice [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-18-03.