PSG Clinical Trials Course
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The Parkinson Study Group (PSG) Mentoring Committee offers a PSG Introduction to Clinical Trials Course created and facilitated by the PSG/PDF Mentored Clinical Research Awardees. This course is composed of a sequence of three one-hour seminars. One seminar will be presented each year during the PSG annual meeting. |
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As one of the main goals of the PSG is to advance knowledge and improve the treatment of Parkinson’s disease through the conduct of multicenter clinical trials the course will focus on: 1) a brief introduction to clinical trial conduct and methodology; 2) introducing new members to PSG clinical trial development and member participation and 3) how to approach data mining from completed PSG trials. |
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This format will teach new PSG members the fundamentals of clinical trial conduct and facilitate participation in PSG trials and database mining. Click on each of the speakers names below to view the course powerpoint presentations. |
| Presentation 1: Introduction to PSG Clinical Trials (Course given at PSG Annual Meeting 2011) |
| A. Intro to Course and Overview of Clinical Trial Development I (e.g., sequence of trial phases); Speaker: Gregory Pontone |
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B. A Framework for Clinical Trial Development and Implementation (Example of PSG Trial Coordination); Speaker: Bernard Ravina |
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C. How to Get Involved in PSG Clinical Trials (and PSG resources for multicenter trials) facilitated by Xiang Gao; |
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D. Data-mining opportunities (data-mining project PI to speak to what is involved and what is available to research) facilitated by Amie Peterson; Speaker: Un Kang |
| E. Panel of speakers – questions and answers and closing remarks by James Boyd |
| The MCRA awardees and speakers have graciously given us their permission to list their email addresses for the audience to contact them if they have questions after the program. |
| Greg Pontone: gponton1@jhmi.edu |
| James Boyd: james.boyd@vtmednet.org |
| Amie Peterson: peterami@ohsu.edu |
| Xiang Gao: hpgao@channing.harvard.edu |
| Bernard Ravina: bernard.ravina@biogenidec.com |
| Michael Schwarzschild: MichaelS@helix.mgh.harvard.edu |
| Claire Henchcliffe: clh2007@med.cornell.edu |
| Un Kang: ujkang@neurology.bsd.uchicago.edu |
| PSG ANNUAL MEETING – May 2012 |
| Presentation 2: Trial Implementation |
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A. Recruitment |
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B. Trial Design and Statistical Approaches |
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C. Project and Data Management |
| D. Data Analysis |
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PSG ANNUAL MEETING – May 2013 |
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Presentation 3: Ethics, Regulatory Concerns, and Investigator Responsibilities |
| A. Contracts/IRB and Confidentiality |
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B. Safety Monitoring |
| C. Ethical Issues |
| D. Clinical Trial Reporting and Investigator Responsibilities |
| USEFUL INTERNET RESOURCES: |
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PSG Database Inventory: http://psg.nextwaveservices.com/docs/Toolkit/PSG_Data_Base_Inventory.pdf |
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PSG Publications: http://www.parkinson-study-group.org/parkinson-research/publications |
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K30 Courses: http://grants.nih.gov/training/k30.htm |
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NINDS Clinical Trial Methods Course in Neurology: http://www.neurologytrials.org/ |
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ANA Translational and Clinical Research Course for Clinician-Scientists: http://www.aneuroa.org/i4a/pages/index.cfm?pageid=3320 |
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This meeting has been made possible through the Parkinson’s Disease Foundation’s Advancing Parkinson’s Treatments Innovations Grant. |
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