The Certificate Program in Clinical Development focuses on training eligible graduates in the areas of clinical development, regulatory framework for clinical trials and statistical tools for data analysis thereby enabling them to work closely with the medical practitioners /principal scientists involved in design and execution of clinical trials for drug products.

This is a 16-week online program, consisting of six courses. Detailed description of the program structure and course descriptions is outlined below:

Courses
Credits
Duration
BCA 434: Clinical Biostatistics
3
8 weeks
BCA 433: Design of Clinical Trial Conduct, Audit and Compliance
1.5
8 weeks
BCA 438: Clinical Trial Design
3
16 weeks
BCA 442: Pharmacology
1.5
8 weeks
BCA 443: Toxicology
1.5
8 weeks
ALS 441: Data Management Systems for Clinical Trials
1.5
8 weeks

Course Descriptions

BCA 434: Clinical Biostatistics

This course provides a basic primer in statistical methods commonly used in the design of clinical trials. Topics covered are expected to include data reporting and descriptive statistics, probability, estimation, hypothesis testing (parametric, non-parametric, and categorical), multi-sample inference, regression and correlation. Sample size and power estimation methods will be developed for various hypothesis testing scenarios.

BCA 433: Design of Clinical Trial Conduct, Audit and Compliance

This course will provide students with a more in-depth understanding of clinical trial design, conduct and strategy for therapeutic products. Clinical trial design elements will be examined in the context of their impact on clinical trial outcomes. Emphasis will be placed upon trial designs that reflect the biological nature and mechanism of action of the therapeutic product being tested, rather than a cookbook approach. Design elements related to small molecules, antibodies, therapeutic proteins, therapeutic vaccines, and cell and gene therapies will be discussed. Discussions will include operational issues impacting execution of clinical trials and why they are critical elements of successful clinical development programs. Students will gain an understanding of the principles for use of particular biostatical testing procedures and in what context certain methods should be used. There will be an emphasis on clinical development problem solving as students work on team projects and defend their own clinical development solutions in the context of product profiles, strategy and timelines.

BCA 438: Clinical Trial Design

The course will provide in-depth information about conducting randomization, planning sample size, analyzing clinical trials (including phase I, II, III, and IV designs), and reporting and interpreting results of studies. Epidemiologic principles necessary for designing clinical research studies will be reviewed. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, and bio-statistical analysis issues will be discussed. Students will read and critically evaluate current research in the medical literature to enable critical use of published information in the evidenced-based practice of pharmacy. Students will develop a clinical trial research study protocol.

BCA 441: Data Management Systems for Clinical Trials

This course is designed to design data capture methods, and to organize and manage clinical trial data collected from one or more sites. Topics include data flow from site to sponsor, database structures; database management systems including validation, backup, security and electronic data capture (EDC) systems; data capture techniques, data transfer and uploads; data quality methods including data entry, data review and programmatic checking, CRF-to-database audit procedures; analysis-ready database procedures; patient confidentiality; and ICH Guidelines, cGMP 21 CFR part 11 compliant.

BCA 442 – Pharmacology

This course is designed to introduce students to the fundamentals of pharmacokinetics and concepts of drug disposition: Absorption, Distribution, Metabolism and Excretion (ADME). It will focus on the relationship between a drug’s mechanism of action and its effect on the patient in relation to clinical safety. The general principles of pharmacokinetics, pharmacodynamics and pharmacogenomics will be introduced and students will examine clinical safety and drug interactions related to selected body systems such as the autonomic and central nervous systems, the cardiovascular, respiratory, renal, and gastrointestinal systems. Various pharmaceutical dosage forms will also be introduced.

BCA 443 – Toxicology

This course will provide a general understanding of toxicology related to drug development and life-cycle management. Fundamental concepts will be introduced including target organ/systemic toxicity, teratogenesis, mutagenesis, carcinogenesis. It will discuss the similarities and differences in preclinical development plans for traditional small molecules versus biologics as well as advanced therapies. Dose response relationships and how preclinical data is used to select doses for clinical trials will be examined. Case studies will be used to assess toxicology development programs.