Developing a Successful Clinical Research Program

Cara East (Autor)

Buch | Softcover

XIX, 270 Seiten

2018
Springer International Publishing (Verlag)
978-3-319-54692-6 (ISBN)

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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 ofthis 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.

Cara East, MD, FACP, Texas Heart Center, Director, Soltero Cardiovascular Research Center, Baylor University Medical Center, Dallas, TX, USA

Why Do Clinical Research?- How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect.- Choosing Studies.- Starting Clinical Research.- Developing a Budget.- Negotiating a Contract.- Writing a Great Informed Consent (IC).- Starting the Study.- Regulatory Startup.- Recruiting.- Getting Subjects through the Door.- The Screening Visit.- Follow-up Visits.- Maintaining Subject Retention and Avoiding Study Fatigue.- Adverse Events (AE's) and Protocol Deviations.- Contact Research Organizations (CRO's) and Monitors.- Annual Review and Financial Disclosures.- Finishing a Study.- Staff Training and Incentives.- Study Closeout.- Acing an Audit.- Expanding the Team.- Epilogue: Watching Medicine Evolve.- Appendices.

'"Developing a Successful Clinical Research Program' is a compact but comprehensive primer for the new investigator or clinical research site. The book includes practical, clearly written material, such as the beginning of the chapter on starting a clinical research team." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 15 (2), February, 2019)

Erscheinungsdatum	04.08.2018
Zusatzinfo	XIX, 270 p. 10 illus., 2 illus. in color.
Verlagsort	Cham
Sprache	englisch
Maße	127 x 203 mm
Gewicht	515 g
Themenwelt	Medizin / Pharmazie ► Allgemeines / Lexika
Schlagworte	Adverse Event • Auditing • Budgeting • Clinical research team • Clinical staff training • Clinical Trials • contract negotiation • Financial disclosure • Informed Consent • Medical study • patient consent • Patient recruiting • Regulatory review • Research Methodology • Screening visit • Subject retention • Subject screening
ISBN-10	3-319-54692-9 / 3319546929
ISBN-13	978-3-319-54692-6 / 9783319546926
Zustand	Neuware