Global Center for Scientific Affairs
In collaboration with academic medical institutions, MSD has developed three online courses to help prepare future scientists for careers in clinical practice, medical research, industry or with the FDA.
- Course 1: Drug Development and Pharmacology
- Course 2: Principles of Clinical Research and Design
- Course 3: Diversity and Patient Engagement in Clinical Trials
To evaluate the program or obtain courses at no charge for your institution, please send an email to request@msdscience.com.
Physicians must frequently address clinical research and drug development issues, yet many of them have little practical knowledge about those processes. Academic institutions educate future medical professionals, but clinical research and drug development knowledge largely resides within the pharmaceutical industry.
In response to the NIH Roadmap for industry and academic partnerships in clinical research education, the MSD Global Scientific Education Initiative (within the Global Center for Scientific Affairs) was created. In 2010 MSD partnered with faculty at Yale University Medical School to develop an e-learning program for drug development from target identification/validation to post-marketing surveillance. Later, MSD created an e-learning program on all aspects of clinical research. These programs have been utilized at more than 85 schools in 13 countries.
Course Availability and Access
Faculty of any degree-granting institution can request access to these courses at no charge. Currently, the courses are used by undergraduate and graduate medical programs worldwide to augment existing curricula. Courses are available in six languages: English, Latin American Spanish, Simplified Mandarin Chinese, Turkish, Japanese and Russian. Faculty members also have access to case studies and slide presentations. Courses are cloud-based and participants can access them through the Academic Center’s Learning Management Systems (LMS). The courses can be viewed on several types of mobile devices as well as desktop computers.
To evaluate the program or obtain courses at no charge for your institution, please send an email to request@msdscience.com.
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How are New Drugs Discovered?
All phases of the drug discovery process are reviewed in this course, including target validation, lead identification, lead optimization and lead biologics. Participants will learn about biologic drugs, the process of vaccine discovery, how biologics such as vaccines and monoclonal antibodies are discovered, and biosimilar therapeutics.
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Preclinical Studies
This course explains formulation development, common formulations used in Phase 1 clinical studies and key activities that must occur for a molecule to proceed to development. Topics such as absorption, metabolism, disposition and excretion of a drug are discussed, along with the importance of studies for general toxicity, safety pharmacology, genetic and reproductive toxicity and carcinogenicity.
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Testing Individual Drugs in Humans
The three phases of clinical trials in humans as well as the functions of clinical trial development team members are reviewed in this course. Participants will learn about Phase 1 trial design with respect to patients, dosing, and trial duration; the rationale for Phase 2 studies in determining dose regimen; and the methods and requirements for obtaining safety data in Phase 3 trials.
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Regulatory Review Process
Participants will learn about the organizations involved in drug regulation, the purpose of labeling and labeling development as well as establishing an effective global regulatory strategy. Participants will learn the format and contents of a New Drug Application (NDA), the process of developing and submitting an NDA for FDA review and approval, and the role of the FDA Advisory Committee.
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Postmarketing Studies and Safety Surveillance
This course examines the need for Phase 3b and Phase 4 studies to further follow clinical trial patients, expand the knowledge base for an approved drug and investigate new uses of the medicine. Participants will learn the role of pharmacoepidemiology in product postmarketing support. The basic activities of risk management and monitoring drug safety are discussed, including the role of physicians in ensuring safety.
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The Principles of Vaccine Development and Clinical Vaccinology
This is a general discussion of the similarities and differences developing and manufacturing vaccines compared with small molecule development. The course also discusses how vaccines protect the population and post-licensure surveillance and safety monitoring.
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Principles of Clinical Research
This course explores all aspects of clinical research— the systematic investigation of human biology, health or illness. Randomized trials, epidemiology studies, statistical concepts, measuring study variables and ethics in research are covered, as well as study protocols and key design principles. The course also examines the roles of clinical study investigators, sponsors, industry partners and regulatory authorities.
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Randomized Clinical Trials
Randomized trials represent the highest level of scientific rigor in the evaluation of medical products. The course covers the goals and benefits of this type of trial and keys to effective trial design. Features of an effective randomized trial protocol are reviewed, including objectives, hypotheses, interventions, controls for bias and confounding, data collection and endpoints.
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Non-Interventional Studies—Epidemiology
This course examines how epidemiology and pharmacoepidemiology contribute to non-interventional studies that lead to prevention of infectious disease outbreaks and epidemics. The design of effective noninterventional (observational) studies is discussed along with epidemiology protocols, including timing of data collection and assembly, observation of patients and health patterns in real-life settings.
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Other Non-Interventional Studies
Steps for developing an outcomes research study that examines the effects of medical treatments are reviewed in this course. Those steps include establishing study objectives, developing a conceptual model, conducting a literature review, defining key variables, methods of data collection and developing a research plan. Use of mathematical health economic models to estimate long-term consequences of treatment is explored.
To evaluate the program or obtain courses at no charge for your institution, please send an email to request@msdscience.com.