The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream.

Benefit-risk assessment is the cornerstone of decision making in medical care, playing a critical role in bringing treatments to market by informing decisions regarding drug development, licensing and reimbursement, and informing treatment decisions made by health care professionals and patients in clinical practice. In regulatory approval decision making, benefit and risk attributes are identified and defined based on available, aggregated clinical data from registration trials. In the context of major developments in recent years for involvement of patients as partners in all phases of drug development and in health care improvement, decision makers increasingly recognize the importance of informing treatment decisions by patient needs, values, experiences, and preferences.

Dietary Anthocyanins: A Review of the Exercise Performance Effects and Related Physiological Responses.

Foods and supplements high in anthocyanins are gaining popularity within sports nutrition. Anthocyanins are pigments within berries and other colorful fruits and vegetables. They have antioxidative and anti-inflammatory actions that improve recovery from exercise.

Using Individual Experiences With Experimental Medications to Predict Medication-Taking Behavior Postauthorization: A DIA Study Endpoints Workstream.

From humanistic, clinical, and economic perspectives, it is important to understand patients' health care attitudes and behavior. Of particular interest in defining the value of a pharmacologic therapy is medication adherence. A DIA workstream was convened to define medication adherence in a drug-development context, explore the relevance of medication nonadherence from various stakeholder perspectives, examine methods of collecting medication adherence data in, or alongside, drug-development programs, and propose a robust approach to predicting medication adherence in routine clinical practice from data derived in, or alongside, drug-development programs.