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Rutgers SHP Requirements for Graduation and Course Descriptions

Department of Health Informatics

Clinical Research Management

BPHE5310 - Scientific Concepts and Research Design

Course Description

Scientific Concepts and Research Design is designed to teach entry-level graduate students the fundamentals of a good clinical trial in the evaluation of a new drug or device. Phases of drug discovery from bench to market, and a high-level (mostly U.S.) perspective on related regulatory issues are covered. Students learn about the roles of CT stakeholders (patient, sponsor, authorities, investigator, coordinator IRB, DSMB, others) and about trial design fundamentals. Human subject protection, safety considerations, and literature-searching fundamentals that apply course learnings are stressed. Adaptive trial strategies, epidemiological methods, randomization plans, quality assurance, treatment masking, business considerations (external funding, budget, cost-effectiveness, other cost-benefit issues), are also touched on.

Credits/Modes of Instruction

Credits: 3

This course is a 3-credit, graduate course provided via the internet using the Canvas Platform.

The course is taught using a web-based format (directed study) with:

Assigned readings and slide presentations

Links to relevant internet sites; Yale-Merck Education Modules

Discussion forums

CITI Certification

Written Assignments 1 (literature searching) and 2 (primary endpoint)

Assignment 3 Summary Basis-of-Approval Slide Deck with narration

Midterm Exam- Study Outline

Final Exam- Draft Protocol

Journal Club – Two live online web-conference

Assignments, handouts, discussion boards, web-conference sessions, links, readings, and other information will be available at the course website.

Lecture slide presentation, on the course lesson page, can assist the student in extracting the most relevant information from the readings. Websites provide more information and examples to clarify discussed material. Through directed study, the student will learn and apply the content materials by completing structured assignments and activities.

Prerequisites

None

Course Goals and Outcomes:

Goals

To familiarize students with clinical trial fundamentals, research design, drug development phases, and the basics of conducting a trial and its overall impact on a product’s journey from concept to commercialization.

Outcomes

Review drug evaluation process including 4 phases of product development and post registration observational studies in clinical research and GCP guidelines’ impact on quality.

Know the basics (as per FDA and ICH E6) regarding clinical trials that meet the effectiveness requirement for drug approval.

Describe key concepts regarding human subject protection, informed consent, & institutional review boards in scientific research and obtain CITI certification.

Explain scientific basis of causation and shortcomings of observational epidemiology in evaluating it (review observational research designs and related study bias issues).

Highlight the role of post-marketing/phase IV safety surveillance in assessing long-term safety & efficacy of commercially available products.

Demonstrate drug- & device-focused clinical-trial literature searching in conjunction with PICO-question competency.

Demonstrate application of knowledge from all objectives in course outputs via semester basis-of-approval slide deck that optimizes the visual display of scientific data and the development of a detailed study outline.