Clinical Trials
Overview
Clinical Trials are a key tool in the evaluation of new strategies for prevention and treatment of disease. This certificate program focuses primarily on the design and analysis of randomized clinical trials for evaluation of licensed and non-licensed medical products and other health interventions, the regulatory framework for the conduct and evaluation of data from clinical trials, and ethical principles for the conduct of clinical trials.
Educational Objectives
After completing the certificate, students will be able to:
- Summarize the history of clinical trials and describe the role they play in evaluation of health interventions;
- Explain the key differences, advantages and disadvantages of experimental versus observational study designs;
- Develop a protocol, consent statement, monitoring plan and data collection plan for a clinical trial;
- Review and critique manuscripts presenting the results of clinical trials using CONSORT guidelines; and
- Explain the key ethical principles regarding the design, conduct and analysis of clinical trials
Eligibility
The certificate program is open to graduate students currently enrolled in any division of the Johns Hopkins University, with the exception of MAS students, who are not eligble to apply until they have completed their primary degree program. It is open to individuals who are not enrolled in degree programs at JHU.
Admissions Process
Applicants should review the How to Apply page for information about eligibility and special instructions. The certificate program's review committee will review the applications and notify each applicant of their admissions decision.
Requirement for Successful Completion
The certificate requires at least 18 credit units that consist of core courses in clinical trials, epidemiology, and research ethics, as well as elective courses focusing on specific issues in the design, conduct and analysis of clinical trials. The required courses in clinical trials include introductory courses in epidemiology, clinical trials design and interpretation and clinical trials methodology. Students are also required to take at least 2 additional courses relating to clinical trials and 1 course in research ethics.
Each student will work with a faculty mentor to develop a protocol and plan for obtaining consent, e.g., prototype statement, for a randomized clinical trial. The protocol will be 8 to 10 pages long and accompanied by consent statement(s) or other materials appropriate for obtaining consent for the proposed trial. Students may complete this requirement in conjunction with a class or sign up for 1 to 2 credits of independent study for this project. The credits for an independent study to work on the protocol can be counted towards the 18 credits required for the certificate program; in this case, the independent study course would replace one elective class. Protocols and consent statements developed in the context of a class will be submitted to the student’s certificate mentor for review.
Students are strongly encouraged to participate in the seminars, research in progress meetings, journal club and other activities sponsored by the Center for Clinical Trials.
All required and elective courses must be taken for a letter grade and a 2.75 or better overall GPA for all Certificate courses is required. The certificate program length is flexible; it varies from student to student, however, the program must be completed within three years.
The student should review the section of the website that addresses completion before completing certificate program requirements. The student's transcript will not indicate that the certificate was earned until the Notification of Completion has been submitted, verified by the certificate program, and processed by the Registrar.
Course of Study
Students should check the course catalog to confirm when the courses are offered. The term and time may change from what is listed in the table below and some courses are only offered every other year. Students should also check for prerequisites and whether instructor consent is required.
Course No. | Course Title | No. Credits | Online Term | Campus Term |
| Introduction to Online Learning All students are required to complete this free course before taking other online courses. | 0 | 1,2,3,4 Summer | - |
Academic and Research Ethics at JHSPH All students are required to complete this free online course during their first term of study. | 0 | 1,2,3,4 Summer | - | |
Required Courses: Students must take 3 required courses | ||||
| Students must take either 340.601 OR 340.721, but not both | ||||
| 340.601 | Principles of Epidemiology OR | 5 | - | S, SI |
Epidemiologic Inference in Public Health | 5 | 3, SI | 1 | |
Introduction to Clinical Trials | 3 | 1 | 2 | |
Power and Sample Size for the Design of Epidemiologic Studies | 1 | 3,SI | - | |
Students should take all courses in either Sequence A, B or C | ||||
| Sequence A: | ||||
| 340.861 | Clinical Trials:Procedures, Design and Interpretation of Results | 3 | 3 | - |
| Sequence B: | ||||
| 340.633 | Data Management in Clinical Trials | 3 | - | 3 |
Clinical Trials Management | 3 | - | 4 | |
| Sequence C: | ||||
Data Management in Clinical Trials | 3 | - | 3 | |
Topics in Management in Clinical Trials | 2 | - | SI | |
| Other Clinical Trials Courses (2 courses required) | ||||
Biostatistics in Medical Product Regulation | 2 | - | - | |
| 140.634 | Non-inferiority and Equivalence Clinical Trials | 2 | - | - |
| 140.642 | Design of Clinical Experiments | 3 | - | 3 |
| 223.664 | Design and Conduct of Community Trials | 4 | - | 3 |
| 223.690 | Design and Analysis of Cluster Randomized Trials | 2 | - | 4 |
| 223.705 | Good Clinical Practice: A Vaccine Trials Perspective | 4 | 4 | - |
| 340.606 | Systematic Reviews and Meta-Analysis | 6 | - | 3 |
| 340.686 | Introduction to Systematic Reviews and Meta-Analysis | 2 | - | SI |
| 340.840 | Independent study in Clinical Trials - students interested in pursuing this option should contact a faculty member before registering | Var | - | 1,2,3,4 |
| 390.631 | Principles of Drug Development | 2 | - | 1 |
| One of the following courses, but not both, may be counted towards the certificate program | ||||
| 410.649 | Introduction to Regulatory Affairs* | - | ||
| 410.676 | Food and Drug Law* | - | ||
| Ethics (1 course required) | ||||
| 306.665 | Research Ethics and Integrity: US and International | 3 | - | 3 |
| 390.673 | Ethical and Regulatory Issues in Clinical Research | 3 | 2 | 1 |
SI=Course is offered in the Summer Institute in Baltimore
*Course is offered by the Johns Hopkins Krieger School of Arts and Sciences, Advanced Academic Programs. Please visit their website for information about timing and registration
Sponsoring Department
Contact Information
Certificate Program Contact
Name Sheila Small
Phone 410.502.9049
Email ssmall2@jhu.edu
Faculty Sponsor
Name Kay Dickersin
Faculty Co-Sponsor
Name Janet Holbrook
GAINFUL EMPLOYMENT PROGRAM INFORMATION
In accordance with US Department of Education regulations, the JHU Bloomberg School of Public Health is required to disclose graduation rate data, median loan debt data, and other select information for all Title IV eligible gainful employment programs. To see the most recent data available for this gainful employment program, please view the attached disclosure.