Clinical research has often ignored involving patients, except as trial subjects. This is slowly changing, through the efforts of patients themselves and others involved in the industry. Some of the developments include involving patients in the actual discovery and developmental strategies, direct influence upon operational plans, recruitment and regulatory input. Being aware of the needs for all involved: patients, patient organizations, sponsors and regulators, is important in order to plan a successful integration. Awareness of special needs and conditions, for instance in emerging regions, will be discussed. Examples of how to approach and implement patient involvement in clinical research will be presented.
Nancy Meyerson-Hess has over 30 years of experience in leading global clinical research teams in pharmaceutical and contract research organizations. She has focused on providing best practices for success in global clinical research, including emerging regions, in areas such as Good Clinical Practice and Inspection Readiness. In addition, she has extensive experience in patient-centered activities and solutions. Nancy is Chief Compliance and Regulatory Officer eMQT Emerging Markets Quality Trials, a non-profit. She also provides support as a consultant in clinical research with a focus on clinical trials and outsourcing through quality and process improvement.