Clinical Research for Cardiovascular Pharmaceuticals

This event qualifies for 12 RAPS

Understanding basic clinical research requires excellent people and project management skills, and very good scientific writing and organization skills. Also paramount is gathering necessary information to manage the statistical analysis and data management of all the many clinical studies.

The clinical development plans must be laid by experienced leaders and project managers. The clinical plan includes the budgets and timeline necessary to properly research the drug and advance it through all the testing necessary to achieve approval by FDA. The various phases of drug development (Phases I-IV) are necessary for most new chemical entities. Protocols are required for all clinical tests and this usually starts with a literature review, establishing key efficacy and safety parameters and determining proper sample size.

Sample size calculations are a very important aspect of clinical trials, as are the data collection forms, therefore the statistics and data management departments must be included for their input into the protocol and timelines. An initial input, draft review and final protocol review meetings of all concerned departments should also include labeling, manufacturing, regulatory, legal, project management.

It is also a good idea to get individual investigators input into the protocol design and data collection forms. At this point they can also create a draft budget for their participation. Once all input has been gathered the sponsor approval process can proceed. Once the sponsor has approved the protocol, all relevant IRBs are asked by their investigators to approve the protocol. The FDA must be sent a copy of the protocol and if critical feedback isn't received in 30 days, the study can go forward. Writing a single protocol can take a month or more.

Areas Covered in the Session:

Basic Clinical Research,
Scientific Methodology,
Regulations and Law
Basic Project Management
FDA and IRBs

Who Will Benefit:

Clinical Research Associates
Scientists
Nurses
Pharmacists
Pharmacologists
Doctors
Medical Directors

Speaker and Presenter Information

Charlene M. Jett
President- 3R's Management Consulting and Therapeutics Inc

Charlene M. Jett lives in Vandalia Illinois about 70 miles east of St. Louis. She is a scientist, clinical researcher, consultant, adventurer, volunteer, daughter of Charles W. and Sybel Harre. Charlene is well educated and has a Master's of Science in Management (1990) from Lake Forest Graduate School of Management, Lake Forest Illinois, a Master's of Science in Biology (1980) from Northeastern Illinois University, Chicago, Illinois and a Bachelor's of Science in Physiology (1972) from University of Illinois, Champaign-Urbana, Illinois.

Charlene is the founder, president and principal consultant of 3R's Management Consulting and Therapeutics Inc., and (1988-present). She has experience and expertise in Alzheimer's, dementia and memory problems. She has knowledge and experience in cardiovascular diseases and treatments and clinical trials. She has experience as a project manager for a fluoroquinolone antibiotic in aquaculture. She has been involved in regulatory reviews, scientific discovery and invention. She was a consultant for U.S. Army (twice) and the American Red Cross, with management level responsibilities. Charlene is experienced in making presentations, writing publications and reports, teaching and training. She taught graduate statistics and undergraduate ethics at National Louis University west of Chicago in 1991.