Clinical Trials

Providing resources for professional development, education, sound practices, mentorship and networking in support of clinical trials.

Leadership

CO-CHAIRS
LeeAnn I. Ali, Sepracor
Philip T. Lavin, Averion, Inc.
Larry Blankstein , Genzyme

Mission

To provide resources for professional development, education, sound practices, mentorship and networking in support of clinical trials.

Action Plan

  • To locate and share industry and regulatory guidelines, journals, articles, references, standard operating procedures, and consultant resources for conducting clinical trials whether internally or with external clinical trials organizations.
  • To serve as a resource for information about training programs for clinical research professionals in order to meet the growing needs of the industry.
  • To identify and to provide a network of local mentors for professionals involved in clinical trials.
  • Hosting presentations relating to current issues within clinical trials.
  • To pinpoint areas that require guidelines to ensure consistency in carrying out clinical trials.

Topics

PREVIOUS TOPICS ADDRESSED
  • The Common Technical Document
  • EDC opportunities and limitations
  • Sharing responsibilities with CROs
  • Cardiac safety monitoring in clinical trials
  • Electronic records
  • Use of Quality of Life measures in clinical trials
  • Legal issues relating to clinical trials

CURRENT TOPICS

  • Development of Oncology Treatments
  • Merger of HER/EDC
  • Upfront Contingency Planning
  • Adaptive trial design
  • European Union Clinical Trials Directive
  • European regulations on pharmacovigilance

Meetings

Date Event
5/9/08 An Overview of Recent Developments in Clinical Trial Registries
4/11/08 Designing Clinical Trials: Locating Efficacy and Cost-Reimbursement Issues -- CANCELLED
6/13/08 Clinical Trial Committee Working Group: Developing A Project Tracking Tool

Past Presentations

Date Presentation
3/14/08 Mastering Partnerships with CROs

« Back to committees list