Principles and Practice of Clinical Research






This program covers the basics of clinical research (how to formulate a research question, select study population, randomization and blinding methods) to statistical methods (data distribution and classification, statistical tests, sample size calculation, survival analysis, missing data and meta-analysis); data collection, monitoring and reporting (include training in manuscript writing); and study designs (observational studies, non-inferior and adaptive designs and randomized clinical trials).

Location and Directions

Harvard T.H. Chan School of Public Health

677 Huntington Ave, Boston, MA 02115

By Public Transportation:
Green Line (E Train) - Brigham Circle

What to Expect

Our collaborative distance-learning training program in clinical research is offered to participants from Boston and throughout the world. 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.

Learning Objectives: 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, and describe more complex clinical trial designs.

Format

This program is a distance-learning program; however, participants have to attend weekly 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 are required to participate in forum discussions, read articles and 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 Proposal Writing workshops will also be offered in Boston, MA.

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

Who Should Attend

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 as well as participation in the program activities is a requirement for the successful completion of the program. On-site participants are required to be present during the videoconference activities.

Investment in the Future

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.

Program Content

Our program covers topics from the basics of clinical research (such as how to formulate a research question, how to select a study population, and randomization and blinding methods) to statistical methods (data distribution and classification, statistical tests, sample size calculation, survival analysis, missing data, and meta-analysis); data collection, monitoring, and reporting (including training in manuscript writing); and study designs (observational studies, non-inferiority and adaptive designs, and randomized clinical trials).

Learning Objectives

At the end of the program, participants will be able to design clinical trials and interpret results from statistical analysis 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, and describe more complex clinical trial designs.

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. Additionally, faculty members have been instructed to disclose any limitations of data and unlabeled or investigational uses of products during their presentations.

Learning Tools

The following learning tools are used in our program:

  • Live connection with Harvard (videoconference lectures): our program consists of 25 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/Wiki: 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 Wiki tool—the same tool used in Wikipedia. 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.

TUITION REFUND POLICY

2018 MAIN COURSE COMPONENT REFUNDS: Cancellations on or before Thursday, February 8, 2018 will be issued a refund less a $150 administrative fee per person. Cancellations received between Friday, February 9, 2018 and Thursday, March 8, 2018 will be issued a refund of 50%. After Thursday, March 8, 2018, no refund will be issued. Refunds for main course participants who still wish to attend workshops will be less the non-participant workshop pricing.

2018 WORKSHOP COMPONENT REFUNDS: Substitutions may be made without additional charge. All requests for substitutions or cancellations must be made in writing. Cancellations on or before Monday, June 4, 2018 will be issued a refund less a $150 administrative fee per person. Cancellations received between Tuesday, June 5, 2018 and Monday, July 2, 2018 will be issued a refund of 50%. After Monday, July 2, 2018, no refund will be issued. There will be no exceptions to this policy.

Hardware and Software Requirements

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 4 to 7pm Boston time) and recommended for the online weekly activities (i.e. forum of discussion).

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

  • Google Chrome
  • Mozilla Firefox 11.x or above

Plugins: Some of the multimedia resources in this program require Apple Quicktime, RealMedia, or a Flash player. You will be prompted to download the appropriate plugin when necessary. No plugins are required for general use of the website.

Mac Systems

Mac OS X v10.4, 10.5, 10.6 (Intel)

  • Mozilla Firefox 2.x, 3.x
  • Safari 2.x, 3.x and 4.x
  • Adobe Flash Player 8 or later

Mac OS X v10.4 (PowerPC®)

  • Safari 2.x
  • Mozilla Firefox 2.x, 3.x
  • Adobe Flash Player 8 or later

Mac OS hardware requirements

  • 500-MHz PowerPC G3  or faster or 1.83-GHz Intel Core™ Duo  or faster processor
  • 128 MB of RAM (512 MB recommended)

Windows Systems

Microsoft® Windows® 7 Home Premium, Professional, or Ultimate(32-bit edition, or 64-bit edition with 32-bit browser)

  • Microsoft Internet Explorer 8 or later
  • Mozilla Firefox 3.x
  • Adobe Flash Player 8 or later

Microsoft Windows Vista® Home Basic, Home Premium, Ultimate, Business, or Enterprise (32-bit edition, or 64-bit edition with 32-bit browser)

  • Microsoft Internet Explorer 7 or later
  • Mozilla Firefox 2.x, 3.x
  • Adobe Flash Player 8 or later

Microsoft Windows XP Professional or Home Edition (Service Pack 2)

  • Microsoft Internet Explorer 6 or later
  • Mozilla Firefox 2.x, 3.x
  • Adobe Flash Player 8 or later

Windows hardware requirements

  • Windows XP:  450-MHz Intel® Pentium® II   or faster processor or equivalent (128 MB of RAM, 512 MB recommended)
  • Windows Vista: 1-GHz Intel Pentium II  or faster processor or equivalent (1 GB of RAM)

Additional requirements

Bandwidth: 500 Kbps

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