Medications and Evidence

Credits: 4 CREDITS (2P+2B)
Director(s): Sebastian Schneeweiss
Offered: October
Location: HMS - Harvard Medical School (0)
Open to Exclerks:
Description: Course Directors: Sebastian Schneeweiss, Jerry Avorn, Aaron Kesselheim, Niteesh Choudhry, Julie Lauffenburger Prescription drugs are the most commonly used and effective interventions in all of medicine, but their use can also raise important questions about adverse effects and affordability. This course will integrate clinical, epidemiological, and policy perspectives exposing students to cutting-edge developments on how evidence on medications is generated and used in health care. It will present several perspectives: initial assessment by the FDA based on pre-approval trials, measuring effectiveness and safety in routine care based on epidemiologic studies, their important clinical role in preventing and treating disease, factors affecting patient adherence, balancing benefits and risks in prescribing, coverage by public and private payers, and drug pricing and cost-effectiveness. These themes will be discussed in interactive workshops with a focus on decision making with partial and developing evidence, guest lecturers (such as past or current FDA regulators), clinical case discussions, and site visits. Throughout the course, students will develop their own effectiveness, safety, cost, and adherence analysis projects using longitudinal datasets that describe all medication use and clinical outcomes in a population of ~30 million actual (de-identified) patients, directly employing easy-to-use software. Each student’s analytics project will be coordinated with the lectures, journal clubs, and workshops and will result in a brief report structured like a journal article. Format of classroom-based sessions: Classroom sessions will be divided into three parts. Interactive lectures will set the stage for each of the themes with discussion of the assigned readings. Closely mentored small-group work in journal clubs and interactive workshops, and a mock FDA advisory committee meeting will help students understand how evidence is generated and used, how difficult benefit-risk-cost decisions are made, and how to critically read the medical literature in each of these domains. The third part will be comprised of eight 2-hour computer labs in which students will develop, implement, and report their own studies on medication effectiveness, adherence and cost. Format of clinical/field experiences: One morning of each week will be spent visiting 1) a leading research group in evidence generation (RCTs, database studies), 2) a health technology assessment group making recommendations about prioritizing medication coverage, 3) a non-profit organization focused on dissemination of evidence, and 4) a clinical session of case studies on optimal prescribing in light of effectiveness, safety, and access. Anticipated schedule: All AISC are full time courses. Students are expected to devote 40 hours per week total, divided between scheduled sessions and preparatory work. Students will spend three mornings per week in interactive classroom sessions (presentations and journal clubs), one morning per week in visits with experts or leading groups in evidence generation and assessment, and one morning in interactive small-group workshops. Each Monday and Wednesday there will be two additional 2-hour population database labs in the afternoons to support student projects. (No programming experience required.) Course Manager: Eric Shames