Clinical stroke research is typically performed within the domain of large academic medical centers led by stroke specialists generally well versed in clinical trial methodology and performance. Practitioners who see and treat patients with stroke on a regular basis, either as inpatients acutely or as outpatients after the acute hospitalization, have the opportunity to help advance stroke care by testing the same new and promising therapies that are being employed at academic medical centers. This chapter provides an overview of clinical trial structure and implementation that we hope will provide impetus to the practitioner to consider becoming involved in stroke clinical trials. The benefits to practitioners include providing the same promising treatments that patients receive at tertiary care stroke centers, greater patient satisfaction in knowing they are getting state-of-the-art care, enhanced referral patterns, and financial remuneration, among others. Topics covered include resources needed, relationship to academic medical centers, ethical and institutional review board issues, patient perspective, budget, recruitment, informed consent, data collection and management, safety, outcome measures, and lessons from other diseases.
Relationship Disclosure: Dr Levine has received personal compensation for activities with AstraZeneca and as an expert in medical legal cases. Dr Levine has received personal compensation in an editorial capacity for Stroke Clinical Updates and MedLink. Dr Adamowicz has nothing to disclose. Dr Johnston has received personal compensation for activities with AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Diffusion Pharmaceuticals LLC, NIH-National Institute of Neurological Disorders and Stroke, Ono Pharmaceutical Co., Ltd, Remedy Pharmaceuticals, and sanofi-aventis. Dr Johnston has received personal compensation in an editorial capacity from Up-to-Date.
Unlabeled Use of Products/Investigational Use Disclosure: Dr Levine discusses the unlabeled use of experimental therapies for stroke. Dr Adamowicz has nothing to disclose. Dr Johnston discusses the unlabeled use of investigational therapies.