Principles and Practice of Clinical Research

Our collaborative distance-learning training program in clinical research is offered to participants from Boston and worldwide. It is designed for individuals who wish to gain basic and advanced training in clinical trials before moving into the field and for those who have experience in this area and aim to broaden their role in the design, management, analysis, and reporting of clinical trials. 

Applicants usually have a graduate degree or a healthcare professional degree (MD, MPH, Biostatistics, Epidemiology, Nursing, Physical and Speech Therapy, Pharmacy, and Dentistry) and come from several countries, given that participants can partake in the program remotely in their own city. Although participants can take this program locally, interaction with other students and instructors and participation in the program activities is a requirement for its successful completion. On-site participants must be present during the weekly videoconference activities. 

At the end of the program, participants will be able to:

• Design clinical trials in an effective manner
• Collect data appropriately
• Use the basic functions of a statistical software package
• Choose appropriate basic statistical tests
• Run statistical analysis
• Critically read and understand a research paper
• Develop clinical research based on integrity principles
• Discuss the basics of article publication and the reviewing process
• Describe more complex clinical trial designs.

To participate in this distance-learning program, participants will need regular access to a computer with excellent internet connection, email, a PDF viewer, and a webcam and microphone connected to the computer. 

This program is a distance-learning program; however, participants must attend weekly live 3-hour interactive video-conference sessions with participants from the same location (for instance, participants from Dresden, Germany meet at University of Dresden for the live connection with Harvard). The videoconference sessions are broadcast from Harvard to different centers across the world (individual participants can also participate via web-conference). Participants must participate in forum discussions, read articles, complete assignments and statistical exercises. At the end of the 9-month program, there will be a recommended 5-Day Immersion Course to practice the concepts learned in this program. An optional 3-Day Advanced Statistical Workshop and Research Manuscript Writing workshops will also be held in Boston, MA. 

Tutorial Lecture: March 27th, 2025–Felipe Fregni-Program Staff and PPCR Program Director

• Syllabus and discussion of the program format
• Team introduction
• Sites introduction
• Using the Collaborative Learning Method: An overview
• Website tutorial
• Discussion 

Optional Lecture: How to Maximize Your Learning in PPCR, Tips from a PPCR Alumni March 28th, 2025, 7-8:30am 

Office Hours/Group Discussion: April 9th, 2025. 6-7pm

Lecture 1: April 10th, 2025–Felipe Fregni & Arjun Manrai/Selection of the Questions

• Primary Question, and AI in Clinical Research 
• Primary question
• Secondary questions
• Adverse effects
• Ancillary questions
• Natural history
• Frequent errors

Optional Lecture: April 11th, 2025, 7-8:30am 

Office Hours/Group Discussion: April 11th, 2025, 12-1pm and April 16th, 2025, 6-7pm

Lecture 2: April 17th, 2025–Stefania I. Papatheodorou/Guide for Scoping and Systematic Review

• Scope Reviews
• Systematic Reviews
• Literature Search/Databases
• Critical Appraisal of the Literature

Optional Lecture: April 18th, 2025, 7-8:30am 

Office Hours/Group Discussion: April 18th, 2025, 12-1pm and April 23th, 2025, 6-7pm

Lecture 3: April 24th, 2025–Albert Hofman-Clinical Research: A 360° Journey from History to Modern Advances/Felipe Fregni- Literature Search/Databases/Critical Appraisal of the Literature

• Introduction to Clinical Trials 
• Why Perform a Clinical Trial? 
• What is a Clinical Trial? 
• Phase I studies; Phase II Studies; Phase III/IV Studies 
• Introduction to Ethics of Clinical Trials 
• Subgroup analysis
• Comparison of multiple variables
• Meta-analysis of multiple studies

Optional Lecture: April 25th, 2025, 7-8:30am 

Office Hours/Group Discussion: April 25th, 2025, 12-1pm and April 30th, 2025, 6-7pm

Lecture 4: May 1st, 2025–David Wypij-Basic Study Design, Adaptive Design and Nof 1 & Assessment of Bias in RCTs Tools (Cochrane)

• Observational studies
• Randomized control studies
• Nonrandomized concurrent control studie
• Historical controls/databases
• Cross-over designs
• Factorial design
• Studies of equivalence
• Large clinical trials

Optional Lecture: May 2nd, 2025, 7-8:30am 

Office Hours/Group Discussion: May 2nd, 2025, 12-1pm and May 7th, 2025, 6-7pm

Lecture 5: May 8th, 2025–David Wypij-Randomization Process & Blinding

• Fixed allocation randomization
• Simple randomization
• Blocked randomization
• Stratified randomization
• Adaptive randomization procedures
• Mechanisms of randomization

Optional Lecture: May 9th, 2025, 7-8:30am 

Office Hours/Group Discussion: May 9th, 2025, 12-1pm and May 14th, 2025, 6-7pm

Lecture 6: May 15th, 2025 Roger Davis-Statistics-Basics

• Data classification
• Descriptive methods for data
• Descriptive methods for categorical data
• Descriptive methods for continuous data

Optional Lecture: May 16th, 2025, 7-8:30am 

Office Hours/Group Discussion: May 16th, 2025, 12-1pm and May 21st, 2025, 6-7pm

Lecture 7: May 22rd, 2025–Michael Stoto-Meta-Analysis of Multiple Studies 

Optional Lecture: May 23rd, 2025, 7-8:30am 

Office Hours/Group Discussion: May 23rd, 2025, 12-1pm and May 28th, 2025, 6-7pm

Lecture 8: May 29th, 2025–Heather Baer-Observational Studies and Bias Tools

• Overview of observational studies (cross-sectional studies, cohort studies, and case-control studies)
• Confounding in observational studies

Optional Lecture: May 30th, 2025, 7-8:30am 

Office Hours/Group Discussion: May 31st, 2025, 9-10am and June 4th, 2025, 6-7pm

Lecture 9: June 5th, 2025–Lidia Moura-Safety, Clinical and Surrogate Outcomes

• Reliability of measurements
• Validity of measurements
• Introduction to safety, clinical, and surrogate outcomes

Optional Lecture: June 6th, 2025, 7-8:30am 

Office Hours/Group Discussion: June 6th, 2025, 12-1pm and June 11th, 2025, 6-7pm

Lecture 10: June 12th, 2025–Heather Baer-Confounders in Observational Studies: Using the Method of Propensity Scores

• Motivation for propensity scores
• Definition of propensity score
• Main steps in propensity score analysis
• Comparison of propensity score analysis with outcome models

Optional Lecture: June 13th, 2025, 7-8:30am 

Office Hours/Group Discussion: June 13th, 2025, 12-1pm and June 18th, 2025, 6-7pm

Lecture 11: June 19th, 2025–Anna Modest-Study Population & Selection Bias

• Definition of study population
• Issues on generalization
• Trade-off: Internal validity vs. external generalizability
• Examples from landmark studies 
• Unblinded trials
• Single blind trials, Double blind trials, Triple blind trials
• Assessment of blindness

Optional Lecture: June 20th, 2025, 7-8:30am 

Office Hours/Group Discussion: June 20th, 2025, 12-1pm and June 25th, 2025, 6-7pm

Lecture 12: June 26th, 2025–Mark Barnes-Integrity in Research

• Disputes about authorship-when authorship fails
• The right or otherwise to publish data, patents, and grant funding
• Scientific integrity and misconduct
• Publication practices
• Conflict of interest

Optional Lecture: June 27th, 2025, 7-8:30am 

Office Hours/Group Discussion: June 27th, 2025, 12-1pm and July 2nd, 2025, 6-7pm

Lecture 13: July 3rd, 2025–Felipe Fregni-Correlation-Intro to Linear Regression-Confounding Adjustment and Effect Modification

• Mid-Check Review
• Adaptive Designs
• Interim analysis 
• Chi-square and Fisher’s exact test
• Trend test for categorical data

Optional Lecture: July 4th, 2025, 7-8:30am

6-Week–Group Project-Designing a Grant Proposal and July Workshops Group

Lecture 14: August 14th, 2025-Felipe Fregni-Intention to Treat Analysis and Missing Data-Publicly Available Datasets and Real World Data

• Missing data
• Intention-to-treat analysis
• Covariate adjustment

Optional Lecture and STATA Review: August 15th, 2025, 7-8:30am 

Office Hours/Group Discussion: August 15th, 2025, 12-1pm and August 20th, 2025, 6-7pm

Lecture 15: August 21st, 2025–Brian Healy-Statistical Tests I

• Estimation of parameters
• Comparison of population means (student t-test)
• Nonparametric tests for two group comparisons (Mann-Whitneyand Wilcoxon Signed Rank Test)

Optional Lecture and STATA Review: August 22nd, 2025, 7-8:30am 

Office Hours/Group Discussion: August 22nd, 2025, 12-1pm and August 27th, 2025, 6-7pm

Lecture 16: August 28th, 2025–Brian Healy-Statistical Tests II

• Parametric and Nonparametric tests for more than two group comparisons (Analysis of variance (ANOVA) and Kruskal-Wallis) 
• Correlation (Pearson and Spearman correlation coefficient)

Optional Lecture and STATA Review: August 29th, 2025, 7-8:30am 

Office Hours/Group Discussion: August 29th, 2025, 12-1pm and September 3rd, 2025, 6-7pm 

Lecture 17: September 4th, 2025–Felipe Fregni-Statistical Tests III 

• Chi-square and Fisher’s Exact Test 
• Trend Test for Categorical Data 

Optional Lecture and STATA Review: September 5th, 2025, 7-8:30am 

Office Hours/Group Discussion: September 5th, 2025, 12-1pm and September 10th, 2025, 6-7pm 

July 11th-August 14th, 2025: There will be a five-week break with no lectures. This break is designed for participants to work on the the data analysis project. There will be mandatory weekly meetings moderated by the TA-II to discuss progress on the group project. Participants should also use the discussion platform (Ryver) to communicate about group project.

Lecture 18: September 11th, 2025-David Wypij-Non-inferiority Designs and Pragmatic Trials

• Superiority Trials 
• Non-Inferiority Designs 
• Goals of Non-Inferiority Designs 
• Choosing the Non-Inferiority Margin 

Optional Lecture and STATA Review: September 12th, 2025, 7-8:30am 

Office Hours/Group Discussion: September 12th, 2025, 12-1pm and September 17th, 2025, 6-7pm 

Lecture 19: September 18th, 2025– Jessica Paulus-Sample Size Calculations 

• Dichotomous response variables
• Sample size for continuous response variables
• Sample size for equivalency of interventional studies
• Estimating sample size parameters
• Practical Example: How to calculate sample size for a grant application

Optional Lecture: September 19th, 2025, 7-8:30am 

Office Hours/Group Discussion: September 20th, 2025, 9-10am and September 24th, 2025, 6-7pm 

Lecture 20: September 25th, 2025-Roger Davis-Survival Analysis

• Estimation of the survival curve (Kaplan Meier estimate)
• Comparison of two survival curves
• Covariate adjusted analysis
• Use of survival analysis in clinical research

Optional Lecture and STATA Review: September 26th 2025, 7-8:30am 

Office Hours/Group Discussion: September 26th, 2025, 12-1pm and October 1st, 2025, 6-7pm 

Lecture 21: October 2nd, 2025-Donald Halstead-Effective Communication in Clinical Research

• Principles of good writing 
• How to write a paper 
• IMRAD

Optional Lecture and STATA Review: October 3rd, 2025, 7-8:30am 

Office Hours/Group Discussion: October 3rd, 2025, 12-1pm and October 8th, 2025, 6-7pm 

Lecture 22: October 9th, 2025–Constantine Gatsonis-Presentation and Graphs-Preparing Impactful Papers and Providing Peer Review (Participant Adherence and Recruitment: online only)

Optional Lecture: October 10th, 2025, 7-8:30am 

Office Hours/Group Discussion: October 10th, 2025, 12-1pm and October 15th, 2025, 6-7pm 

Lecture 23: October 16th, 2025–Steven Freedman/Funding & IRB (Industry-Academia Interaction: Challenges and Opportunities)

Optional Lecture: October 17th, 2025, 7-8:30am 

Office Hours/Group Discussion: October 17th, 2025, 12-1pm and October 22nd, 2025, 6-7pm 

Lecture 24: October 23, 2025–Howard Sesso-Multicenter Trials and Industry-Academia Collaboration 

• Challenges for multi-center trials
• Data monitoring
• Site selection
• Funding and regulatory issues

Optional Lecture: October 24th, 2025, 7-8:30am 

Office Hours/Group Discussion: October 24th, 2025, 12-1pm and October 29th, 2025, 6-7pm 

Lecture 25: October 30th, 2025–Felipe Fregni-Special Panel: RCT vs. Observational Designs-How do you choose? 

• RCTs-why would you choose this design?
• Observational studies-why would you choose this design?

Optional Lecture: October 31st, 2025, 7-8:30am

By helping researchers improve their skills in clinical research in a highly interactive environment, this program will promote personal and professional growth and help participants become more effective in their work. We also expect that the interactive environment of the program will promote connections between participants and help foster future collaborative, multi-center projects. Our goal is to offer a highly interactive learning environment for international clinical research training while creating a global network of clinical researchers to foster future collaboration in clinical research.

The following learning tools are used in our program:

Live connection with Harvard (videoconference lectures): our program consists of 24 lectures taught by faculty from Harvard T.H. Chan School of Public Health, Harvard Medical School, and Tufts Medical Center. Each weekly lecture includes a 60-minute interactive module led by the program director to discuss the online poll and case study written specifically for the program, a 60-minute teaching/lecture module, and 60-minute live question/answer discussion module in which participants interact directly with faculty.

• Discussion forum: Each weekly lecture/topic includes a required online discussion forum.
• Online polls: Participants respond to weekly polls addressing the topic of the subsequent lecture.
• Assignments: Participants are required to submit practical assignments related to weekly lectures, including statistics assignments as part of the statistical training component of the program.
  Asking questions: Participants have intensive interaction with faculty and staff via office hours and the website forum.
• Group Project: Participants are required to participate in a group project in which they work together to write a grant application. The project is created using the online interactive tool. Most participants choose to submit their final project after review with faculty members to our online peer-reviewed international journal for publication (www.ppcr.org/journal)
• Long-term Vision for Participants: Participants are strongly encouraged to continue their interaction through our Alumni community (https://www.facebook.com/groups/ppcralumni/) created to maintain interaction between participants for the discussion of clinical research topics.

Computers: Any computer running Windows or Mac OS are supported.

Internet Connection: Your computer should be configured to access the Internet. A high-speed internet connection (preferably by ethernet) is required during live lectures (Thursdays from 4pm to 7pm EST Boston time) and recommended for the weekly online activities (i.e. forum of discussion and office hours). 

Browsers: Although our website may work with Internet Explorer and Safari, we recommend:

• Google Chrome
• Mozilla Firefox 11.x or above
• Internet Explorer 10.x or above

Harvard T.H. Chan School of Public Health
677 Huntington Ave, Boston, MA 02115
By Public Transportation:
Green Line (E Train) – Brigham Circle

DISCLOSURE POLICY

• All relevant financial relationships with commercial entities will be disclosed. These disclosures will be provided in the activity materials along with disclosure of any commercial support received for the activity. Also, faculty members are instructed to disclose any data limitations and unlabeled or investigational uses of products during their presentations. 

CANCELLATION POLICY FOR PRINCIPLES AND PRACTICE OF CLINICAL RESEARCH MAIN COURSE

• Substitutions may be made without additional charge. All requests for substitutions or cancellations must be made in writing. Cancellations on or before January 31, 2025 will be issued a refund less a $150 administrative fee per person. Cancellations received between February 1, 2025 and March 6, 2025 will be issued a refund of 50%. After March 6, 2025, no refund will be issued. There will be no exceptions to this policy. 

CANCELLATION POLICY FOR PPCR RESEARCH MANUSCRIPT WRITING WORKSHOP AND 3-DAY STATISTICAL WORKSHOP

• Substitutions may be made without additional charge. All requests for substitutions or cancellations must be made in writing. Cancellations on or before June 9, 2025 will be issued a refund less a $150 administrative fee per person. Cancellations received between June 10, 2025 and July 7, 2025 will be issued a refund of 50%. After  July 7, 2025 no refund will be issued. There will be no exceptions to this policy.