Must take five (5).
Clinical Trials: The Industry Perspective
This is a presentation of the process of drug development from the pharmaceutical industry’s perspective Timelines, quality and cost will be driving factors for discussion. The pharmaceutical industry’s general organizational structure will be introduced. The clinical trial protocol development process and clinical study conduct will be presented. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights and intellectual property will also be discussed.
Learning Objectives:
- Understand the drug development process including pharmaceutical industry drivers.
- Understand how sites are selected and contracts are negotiated for clinical trials.
Prerequisites: None
Negotiating Clinical Trial Agreements with For-Profit Companies
Tips, traps and tricks of negotiating clinical trial agreements with the industry including a discussion of conducting negotiations via email versus teleconference discussions. Presenters will role play to illustrate tactics and strategies.
Learning Objectives:
- Analyze negotiation strategies, identify their individual strengths and weakness and list common mistakes made by negotiators on each side of the table.
- Describe the benefits of compromise and tools to help finding it.
Prerequisites: None
Determining Study Feasibility at Your Site
This is applicable for all studies (i.e., investigator initiated, industry funded, foundation funded or federally funded). The goal is to ensuring sufficient interest in the study design and research questions. Not just doing a study to do a study. The next steps are ensure that there are proper resources (i.e., study staffing including coordinators, investigators, research assistants; Institutional Review Board (IRB) and contract review teams, statisticians, etc.) to conduct the study; proper facilities (access to investigational pharmacy; inpatient or ambulatory facilities, etc.) and equipment (centrifuge, freezers, access to MRI or CT equipment); and sufficient and proper patient populations. Determining the proper mechanism for scientific review to ensure validity of the research questions. Proper financial review of direct and indirect costs and access to legal review through the grants and contracts team.
Learning Objectives:
- Is the study answering relevant research questions through rigorous methodologies?
- The ability to analyze the legal, fiscal, ethical and scientific review of clinical trials to ensure that you are choosing the right studies for your site.
- Is this study helpful to your patient populations (i.e. are you meeting the clinical goals important to your medical environment).
Prerequisites: None
Biorepository and Data Management Considerations for Clinical Trials
Changes of the common rule generated much attention around the management of biorepositories and related data in clinical research. This session will address the following topics for research administrators that are involved in clinical trial activity related to biorepository and data management: 1) Discussion of various repository models; 2) Ideas for repository management considerations; 3) Review of multiple regulatory considerations (Health and Human Services, Food and Drug Administration, and Health Insurance Portability and Accountability Act); 4) Impact on informed consent and privacy and confidentiality of data; and 5) Bio-specimen research scenarios for both current and future regulatory considerations.
Learning Objectives:
- Identify different approaches and models for biorepository and data management for clinical research trials.
- Understand the impact of different regulations on bio-specimen and related data management clinical research.
Prerequisites: None
Clinical Trials: Rules and More Rules
Clinical trials must comply with the Good Clinical Practice guidelines (GCP). Unfortunately, the GCP is not well defined. This session will review the Department of Health and Human Services, Food and Drug Administration, and major international regulations and guidelines, as well as other institutions governing clinical research. Participants will learn how the actions of regulatory agencies affect budget development, contract negotiations and the way studies are conducted. Topics will include the ethical origins of the GCP, historic milestones and their regulatory significance, and discussion of best practices to enhance regulatory compliance.
Learning Objectives:
- Identify three important documents that form the core ethical basis for the regulatory environment.
- Identify three best practices for improving regulatory compliance in clinical trials.
Prerequisites: None
Clinical Trials Budget Negotiation
Budgets for clinical trials should be based on sound accounting principles and an accurate analysis of the protocol. Often, establishing the costs for procedures is relatively straightforward, but accurately estimating hidden costs, such as investigator time and start-up costs, can be more difficult. A systematic process for analyzing protocols, determining costs and negotiating budgets will be discussed, along with relevant aspects of contract negotiations and establishing payment schedules. Tips to optimize budgeting for clinical trials will also be presented.
Learning Objectives:
- Learn the four components of a clinical trial budget.
- Explain the differences between budgeting for clinical trials funded by industry versus federal sources.
Prerequisites: None
Research Integrity: The Institutional Perspective
Academic and other research institutions are becoming more and more aware that many faculty, researchers, staff and students are not properly trained in ethics, professional standards and responsible conduct of research. This session provides a brief summary of the overall issues encountered and approaches to enhance the training and competency in research integrity and professional standards across several different types of organizations.
Learning Objectives:
- Identify the institutional and cultural-discipline-specific challenges to Responsible Conduct of Research (RCR) training.
- List strategies to address the challenges in gaining "buy in" and implementing RCR training.
Prerequisites: None