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 health care 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. 

Introduction to Clinical Research, Systemic Review and Critical Appraisal and Design of Experimental Studies/RCTs

Tutorial Lecture – March 28, 2024 – Program Staff and PPCR Program Director – Felipe Fregni

•Syllabus and Discussion of the Program Format
•Team Introduction
•Sites Introduction
•Using the Collaborative Learning Method: An Overview
•Website Tutorial
•Discussion

Lecture 1 – April 11, 2024 – Albert Hofman

Introduction to Clinical Trials:
•Overview of Clinical Research (second lecture) Steven Freedman & Camilia Martin-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

Lecture 2 – April 18, 2024 – Gonzalo Patricio Labarca Trucios

Guide for Scoping and Systematic Review/Literature Search/Databases/Critical Appraisal of the Literature:
•Scope Reviews
•Systematic Reviews
•Literature Search/Databases
•Critical Appraisal of the Literature

Lecture 3 – April 25, 2024 – David Wypij

Basic Study Design/Adaptive Design and Nof1 & Assessment of Bias in RCTs Tools (Cochrane)
• Observational studies
• Randomized control studies
• Nonrandomized concurrent control studies
• Historical controls/databases
• Cross-over designs
• Factorial design
• Studies of equivalence
• Large clinical trials

Lecture 4 – May 2, 2024 – David Wypij

Randomization Process and Blinding:
• Fixed allocation randomization
• Simple randomization
• Blocked randomization
• Stratified randomization
• Adaptive randomization procedures (baseline adaptive randomization procedures)
• Mechanisms of randomization

Lecture 5 – May 9, 2024 – Felipe Fregni

Intention to Treat Analysis and Missing Data
•Missing Data
•Intention-to-Treat Analysis
•Covariate Adjustment

Lecture 6 – May 16, 2024 – Lidia Moura

Safety, Clinical and Surrogate Outcomes and Interventions:
•Reliability of Measurements
•Validity of Measurements
•Introduction to Safety, Clinical, and Surrogate Outcomes

Observational Studies: Design and Critical Appraisal and Introduction to Publicly Available Datasets and Real World Data

Lecture 7 – May 23, 2024 – Heather Baer

Observational Studies and Tool for Assessment of Bias in OS:
•Overview of Observational Studies (Cross-Sectional Studies, Cohort Studies, and Case-Control Studies)
•Confounding in Observational Studies

Lecture 8 – May 30, 2024 – Michele Hacker

Study Population and 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

Lecture 9 – June 6, 2024 – 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

Lecture 10 – June 13, 2024 – Felipe Fregni

Selection of the Questions and Intro to Group Project:
•Primary Question
•Secondary Questions
•Adverse Effects
•Ancillary Questions
•Natural History
•Frequent Errors

Lecture 11 – June 20, 2024 – Felipe Fregni

Publicly Available Datasets and Real World Data:
•Publicly Available Datasets Examples
•How to Use and Conduct Data Analysis in Public Available Data Sets
•Ethics of Publications of Public Available Data Sets
•Why is Real World Data Important
•How to Use Real World Data

Lecture 12 – June 27, 2024 – 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

Lecture 13 – July 4, 2024 – Felipe Fregni

Special Lecture: Mid-Check Review:
•Group Project and Mini Review – Discussion and Feedback

GROUP PROJECT – July 11 – August 22, 2024

Group Project-Designing a Grant Proposal and July Workshops

Group Project Meeting 1: July 11th, 2024, 5-6pm-Introduction, PICOT
Group Project Meeting 2: July 18th, 2024, 5-6pm
Group Project Meeting 3: July 25th, 2024, 5-6pm
Group Project Meeting 4: August 1st, 2024, 5-6pm
Group Project Meeting 5: August 8th, 2024, 5-6pm
Group Project Meeting 6: August 15th, 2024, 5-6pm

Basic Statistical Analysis for RCTs and Observational Studies

Lecture 14 – August 22, 2024 – Roger Davis

Statistics-Basics:
•Data Classification
•Data Distribution
•Descriptive Methods for Categorical Data
•Descriptive Methods for Continuous Data

Lecture 15 – August 29, 2024 – E. John Orav

Statistical Tests I:
•Estimation of Parameters
•Comparison of Population Means (Student T-Test)
•Nonparametric Tests for Two Group Comparisons (Mann-Whitney and Wilcoxon Signed Rank Test)

Lecture 16 – September 5, 2024 – Felipe Fregni

Correlation/Linear Regression/Confounding Adjustment and Effect Modification:
•Correlation (Pearson and Spearman Correlation Coefficient)
•Adjusted Analysis and Predictors
•Introduction to Multivariate Analysis (Analysis with More Than One Independent Variable)

Lecture 17 – September 12, 2024 – E. John Orav

Statistical Tests II:
•Chi-square and Fisher’s Exact Test
•Trend Test for Categorical Data

Lecture 18 – September 19, 2024 – Felipe Fregni

Statistical Tests III:
•Parametric and Nonparametric Tests for More Than Two Group Comparisons (Analysis of Variance (ANOVA) and Kruskal-Wallis)

Other Study Designs and Analysis Tools for Grant Proposals

Lecture 19 – September 26, 2024 – David Wypij

Non-inferiority Designs and Pragmatic Trials:
• Superiority Trials
• Non-Inferiority Designs
• Goals of Non-Inferiority Designs
• Choosing the Non-Inferiority Margin

Lecture 20 – October 3, 2024 – Jessica Paulus and Gonzalo Patricio Labarca Trucios

Sample Size Calculation and Meta-Analysis:
•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
•Subgroup Analysis
•Comparison of Multiple Variables
•Meta-Analysis of Multiple Studies

Lecture 21 – October 10, 2024 – 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

Clinical Research Project Execution and Dissemination

Lecture 22 – October 17, 2024 – Donald Halstead

Effective Communication in Clinical Research:
• Principles of good writing
• How to write a paper
• IMARD

Lecture 23 – October 24, 2024 – Dan Longo

Impactful Papers and Peer Review
•General tips and recommendations for writing strong and impactful papers
•Peer review of manuscripts
•How to perform quality peer reviews
•How to design effective posters and choose the ultimate graphs/figure for your studies
•How to effectively present abstracts and pass your message in research conference
•How to Design Effective Posters
•How to Effectively Present Abstracts and Pass Your Message in Research Conference

Lecture 24 – October 31, 2024 – Steven Freedman

Funding and IRB:
•What Are the Important Components in a Grant Research Proposal
•How to Convey Your Message Effectively in a Grant Proposal Institutional Review Boards (IRB)
•How to Find Grant Opportunities Locally and Internationally
•What is the Main Structure of an IRB and How is the Review Process in a IRB in the US
•What is Important to Include in the Research Informed Consent Form ICF
•What are the Challenges for International Research Collaboration for the IRB

Lecture 25 – November 7, 2024 – Howard Sesso

Multicenter Trials and Industry-Academia Collaboration:
•Challenges for Multicenter Trials
•Data Monitoring
•Site Selection
•Funding and Regulatory Issues

Lecture 26 – November 14, 2024 – 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?

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.