A Guide to Clinical Drug Research

1. Front Matter

   Pages I-X

   PDF

2. Clinical research: From idea to publication

   • Adam Cohen, John Posner

   Pages 1-10

3. Facilities and equipment

   • Adam Cohen, John Posner

   Pages 11-15

4. What does the investigator need to know about the drug?

   • Adam Cohen, John Posner

   Pages 17-38

5. The first administration of a new active substance to humans

   • Adam Cohen, John Posner

   Pages 39-56

6. Planning and coordinating the study

   • Adam Cohen, John Posner

   Pages 57-64

7. The study protocol

   • Adam Cohen, John Posner

   Pages 65-74

8. Study design

   • Adam Cohen, John Posner

   Pages 75-84

9. Data management and statistical analysis

   • Adam Cohen, John Posner

   Pages 85-97

10. Ethical considerations

    • Adam Cohen, John Posner

    Pages 99-109

11. Aspects of study conduct

    • Adam Cohen, John Posner

    Pages 111-126

12. Good clinical practice

    • Adam Cohen, John Posner

    Pages 127-137

13. Communicating clinical research

    • Adam Cohen, John Posner

    Pages 139-156

14. Clinical research in a developing country

    • Adam Cohen, John Posner

    Pages 157-170

15. Computers in clinical research

    • Adam Cohen, John Posner

    Pages 171-197

16. Back Matter

    Pages 199-202

    PDF

A Guide to Clinical Drug Research provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings.
Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmaceutical company, plus agents of the sponsoring companies themselves.

• clinical research
• clinical trial
• drug
• drug research
• medicine
• planning
• research

`.. provides essential background knowledge. The relevant chapters describe simply, but in full detail .... The list of contributors is extensive and impressive ... '
TiPS, 17 (1996)
`This book is an excellent guide into the field of clinical research. This useful book will be of great value to anyone involved in clinical research. The text is presented in an easily readable fashion with well-designed tables. The use of this knowledge will lead to improved quality in clinical research.'
Pharmacy World Sciences, 18:5 (1996)

• Clinical Pharmacology, University of Leiden, Leiden, The Netherlands

  Adam Cohen

• Centre for Human Drug Research, Leiden University Hospital, Leiden, The Netherlands

  Adam Cohen

• Glaxo Wellcome PLC, Beckenham, Kent, UK

  John Posner

Policies and ethics