Developing a Successful Clinical Research Program

This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting. This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit.Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field.Practical and user-friendly, __Developing a Successful Clinical Research Program__ fills a need for a clear guide to developing and improving a first-class research program in any clinical setting. Front Matter ....Pages i-xix Why Do Clinical Research? (Cara East)....Pages 1-10 How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect (Cara East)....Pages 11-18 Choosing a Study (Cara East)....Pages 19-25 Starting a Clinical Research Team (Cara East)....Pages 27-36 Developing a Budget (Cara East)....Pages 37-44 Negotiating a Contract (Cara East)....Pages 45-52 Writing a Great Consent (Cara East)....Pages 53-62 Starting the Study (Cara East)....Pages 63-67 Institutional Review Board (IRB) (Cara East)....Pages 69-76 Recruiting (Cara East)....Pages 77-82 Getting Subjects Through the Door (Cara East)....Pages 83-88 The Screening Visit (Cara East)....Pages 89-99 Follow-Up Subject Visits (Cara East)....Pages 101-107 Maintaining Subject Retention and Avoiding Study Fatigue (Cara East)....Pages 109-118 Adverse Events and Protocol Deviations (Cara East)....Pages 119-125 Contract Research Organizations and Monitors (Cara East)....Pages 127-135 Annual Reviews and Financial Disclosures (Cara East)....Pages 137-144 Finishing the Study (Cara East)....Pages 145-148 Staff Training and Incentives (Cara East)....Pages 149-162 Study Closeout (Cara East)....Pages 163-170 Acing an Audit (Cara East)....Pages 171-180 Expanding the Team (Cara East)....Pages 181-187 Back Matter ....Pages 189-270