On this Page:
- Clinical Trials Transformation Initiative (CTTI)
- National Organization for Rare Disorders (NORD)
- European Medicines Agency (EMA)
The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership that brings together organizations and individuals representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups, and others, to develop evidence-based solutions to clinical research challenges. FDA and CTTI are currently collaborating on the Patient Engagement Collaborative (PEC). The PEC is composed of patient organization and individual representatives who discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at FDA.
The National Organization for Rare Disorders (NORD) works with individuals with rare diseases and the organizations that serve them. NORD, along with its more than 300 patient organization members, is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services. FDA has a Memorandum of Understanding (MOU) with NORD to conduct outreach on ways to enhance incorporating patient experiences into regulatory discussions. FDA and NORD are working together on rare disease listening sessions with rare disease patients, caregivers and advocates to enhance FDA’s clinical and regulatory understanding of diseases and conditions and provide a common understanding of the most urgent needs of patients, caregivers and advocates.
The European Medicines Agency (EMA) and patients have been actively interacting since the creation of the EMA in 1995. Patients and patient groups bring a 'real-life' experience as well as specific knowledge and expertise to scientific discussions on medicines and on the impact of regulatory decisions. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) collaborate on patient engagement activities through the FDA/EMA Patient Engagement Cluster. The cluster allows FDA and EMA to share best practices involving patients along drug and biologic regulatory lifecycles. Information that is discussed is covered by confidentiality agreements signed by the FDA and EMA.