This article describes how behavioral science can be applied in cardiometabolic clinical research to augment drug interventions. This combined approach addresses the Health Inequity gap while also increasing patient engagement.
The recent FDA publication “Submitting Patient-Reported Outcome (PRO) Data in Cancer Clinical Trials” represents a significant leap forward in cancer research and drug development. This detailed guidance for integrating PROs into the drug approval process sets a new standard for the evaluation of cancer treatments.
Technological advancements have broadened the reach of clinical studies to larger and more diverse populations. However, technology alone isn’t sufficient to guarantee successful trial outcomes. The human element, including how technology is utilized by sites, sponsors, and patients in accordance with regulatory guidelines, remains pivotal in ensuring compliance, minimizing risks, and upholding patient safety.
Sponsors considering using data from sensors and wearables in their clinical trials worry about three scenarios: collecting too little data, collecting too much data, and collecting bad data. Each outcome could likely impact their study or a portion of it with a significant waste of time, money, and patient goodwill.
Caregivers play a critical role in oncology trials, providing support and assistance to patients who are dealing with physical, emotional, or cognitive challenges related to their illness and treatment. Caregivers are made up of a wide range of individuals including parents of minor children, adult children of parents, spouses or partners of participants, and home health aides.