Clinical Research for Cardiovascular Pharmaceuticals: Ensuring Compliance of Traditional and New Cardiovascular Medications
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 isnīt received in 30 days, the study can go forward. Writing a single protocol can take a month or more.
Once a clinical and project plan is developed, protocols are created and approved, everyone must be trained. This can take days or many weeks depending on experience and expertise. The final package required for a good solid monitoring team to follow, should consist of approved protocol and consent, data collection forms, listing of all intended principle investigators and contacts, all necessary IRB information. Excellent tracking and communications is imperative. All communication with investigator sites must be documented, as all communications with IRBs and FDA. Generally speaking the monitor is the focus for each site unless problems arise that require sponsor scientific or medical input.
Monitoring must be performed and 100% data checking done unless other arrangements have been made and agreed upon. My preferences are for 100% data checking, and it is very important for first time in man studies. All adverse events must be tracked on the case report forms for each patient and all serious adverse events and deaths must be tracked on the patients case report forms as well as tracked separately. The sites are not expected to communicate with the FDA for routine study management. Only if very serious unresolved persistent study management problems, adverse events or deaths occur, does the site communicate with FDA. The sponsor must be informed prior to any communication with the FDA.
The best outcomes are usually tied to a well-constructed clinical and project plans with excellent protocols and detailed budgets. Most ethical pharmaceutical companies also insist on complete honesty in all aspects of their research. CRAs and monitors must be included as the focus point for budget negotiations and investigator payments. This necessitates the determination of evaluable and non- evaluable patients prior to payments. The best laid plans do not ensure drug safety and efficacy; however no new medications can possibly make it without them.
Why should you attend:
This seminar should be attended to ensure the proper compliance and development of traditional and new cardiovascular medications. Failure to attend could result in poorly managed clinical trials, wasted financial resources and liability based law suits. The development of well-designed clinical trials and rigorous monitoring is required. From the literature review to the last appendix a complete understanding of regulations pertaining to clinical research and monitoring a well-designed protocol is necessary. All project managers know that the critical path thru clinical research is extremely tightly regulated and fraught with pitfalls. Financing by the sponsor/developer of the drug is highly scrutinized for value and good management. Monitoring according to Good Clinical Practice guidelines is required to determine evaluable patients. The more mistakes that are made the higher the cost. It takes 10 times as much time and money to fix mistakes/errors and misunderstandings as it does to do it right from the beginning. It requires significant training, resources and extraordinary diligence, planning and execution to achieve successes in cardiovascular clinical research.
Driving the clinical development, protocols and subsequent monitoring on the project requires increasing knowledge about any drug under development. It must be thoroughly and completely understood, down to the last comma. Similarly the accompanying monitoring of all the protocols, must be completed in an efficient, most forth right manner, to ensure viable data and statistical analysis. The documentation of these efforts by not only the sponsor but by all investigators and staff involved is tremendous. Training of all individuals and monitors must be flawless yet very efficient since this is a very competitive field. In addition, the IRBs and FDA will expect nothing short of perfection.
Clear direction and excellent communication are required to achieve the approval of these new cardiovascular drugs. The proper balance of pushing forward and yet addressing all safety considerations is paramount. Many bottlenecks can be prevented by a determined project manager and medical director who understand how to manage people and projects. Honest assessments of costs in development and monitoring are important to reach the market and significantly improve health and successfully obtain a good return on investment.
Areas Covered in the Session:
Basic Clinical Research,
Regulations and Law
Basic Project Management
FDA and IRBs
Day 1 Schedule:
Pharmaceutical Companies and Planning
Drug Development and FDA Regulations
Clinical Plans and Budgets
Discussion and Q and A
Day 2 Schedule:
Protocols and Monitoring
Medical and Statistical (Evaluable patients)
Reviews and Meetings
Discussions and Q and A
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 Masterīs of Science in Management (1990) from Lake Forest Graduate School of Management, Lake Forest Illinois, a Masterīs of Science in Biology (1980) from Northeastern Illinois University, Chicago, Illinois and a Bachelorīs of Science in Physiology (1972) from University of Illinois, Champaign-Urbana, Illinois.