Clinical Trials
Medtronic is committed to using evidence-based research to bring safe, effective medical therapies to patients. Clinical trials, which Medtronic conducts and sponsors within and across many geographies, play an essential role in this process. Our clinical trials are governed by our Code of Conduct, Business Conduct Policy and our own Clinical Trials Principles, which are designed to develop safety and efficacy data that will directly impact adoption of our therapies in clinical practice.
In addition, we act in accordance with international guidelines, such as the International Conference on Harmonization/World Health Organization Good Clinical Practice (GCP) standards, and actively participate in organizations related to clinical standards development and education, such as the Clinical Trials Transformation Initiative, Clinical Investigations of Medical Devices in Humans (ISO/TC 194/WG 04), Clinical Investigations Working Group, and the Global Harmonization Task Force.
Our Clinical Trials Registry links to information on Medtronic-sponsored clinical studies that are currently registered on www.clinicaltrials.gov.
In a given year, Medtronic conducts or sponsors more than 350 trials worldwide. Since launching our Clinical Trials Registry in 2008, we have listed information on 427 clinical studies at www.clinicaltrials.gov.
Post-market Surveillance
As part of our internal processes to monitor and evaluate clinical evidence related to our therapies, we conduct scientific assessment of health outcomes and systematic reviews of product performance. This information allows us to critically assess the quality of evidence and identify data gaps that may need to be addressed. We regularly submit such evaluations to regulatory and reimbursement authorities for decision-making purposes. Additionally, we respond publicly to requests for review and comment on systematic reviews related to our therapies made by agencies such as the National Institute for Clinical Excellence (NICE) and other agencies around the world that conduct health technology assessments.
Medtronic Chief Regulatory Officer Serves on Executive Board of Clinical Trials Transformation Initiative
Susan Alpert, Medtronic senior vice president and chief regulatory officer, has served on the executive board of the Clinical Trials Transformation Initiative (CTTI) since its inception in 2007. Launched by the U.S. Food and Drug Administration, the CTTI is a public-private partnership charged with identifying practices that through broad adoption will improve the quality and efficiency of clinical trials.
The CTTI was established in response to growing frustration among patients, consumers, the academic community, and industry over difficulties in conducting high-quality clinical trials in a timely manner that would produce information that physicians need to define optimal treatment.
More than 50 organizations comprise CTTI, including government agencies, industry representatives, patient and consumer representatives, professional societies, investigator groups, academic institutions, and other interested parties.