ClinicalTrials101.com

 

 

 

 

Seminar Outline

The 2008 Seminar will meet with clinicians on Saturday morning during the summer. The graduate students and their advisors will also meet on Tuesdays and Thursdays to work on team projects which include the following activities:

I) Read Book: Clinical Trials by Wang & Bakhai

II) Critique selected previously published clinical trials in cosmetic surgery

III) Design Clinical Trial (I propose 4 clinical trials & I will provide a one page clinical synopsis of each of the 4 Clinical Trials below):

1) Laser Assisted Liposuction

2) Surgical Site Infection Prophylaxis using Tumescent Antibiotics

3) Bleeding Volume/Bleeding Time (Phase I, II & III)

4) Open-Drainage Liposuction Post-Operative Care

Write:

¥Protocol, Consent Forms, recruitment of Clinical Investigators & Sujects/Patients

¥Discuss Ethical considerations & Complete Online Course

¥Trial registration (clinicaltrials.com)

¥Study design: type of treatments, number of treatments, blinding/masking,

¥Randomization procedures: Allocation Ratio, Type of randomization, mechanism

¥Describe statistical design and analysis: Objectives, study population, sample size, outcome measures, statistical methods, analysis.

¥Consider Online Trial Management: novel methods for designs involving online multicenter (multiple volunteer clinical-investigators).

IV) Begin a Survey & Critique of Published Cosmetic Surgical Trials

            Published in the Dermatologic Surgery journal in 2008 and perhaps a plastic surgery journal

            Consider writing a review article on the DoÕs & DonÕts of clinical trials in cosmetic surgery

Eventually contributors to this website will be anyone who has an interest in the design of efficient clinical trials