Clinical Trials

❘❙❚■ Chapter 3 | Protocol DevelopmentConclusionWriting a protocol for a clinical trial is a complex, intellectual, and creative task,which is fulfilled by a team of researchers and experts in various areas of researchincluding scientific, medical, statistical, ethical, regulatory, and administrative fields.The protocol is a document that carefully synchronizes knowledge in these areasin accordance with the scientific core of a clinical trial and various quality andregulatory recommendations.In recent years, the development of guidelines has tremendously helped to developstandards for protocol writing in clinical research. This, in turn, has improved themethodology, conduct, and quality of clinical trials, with an ever-increasing ethicalemphasis for all participants in the trial. Lastly, such protocols have becomepublications in their own right, allowing for peer review and feedback on trialassumptions at an early stage in the conduct of a trial.References1. International Conference on Harmonisation. E6: Good Clinical Practice: ConsolidatedGuidelines. Available from: www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254.Accessed May 6, 2005.2. World Medical Association Declaration of Helsinki. Ethical Principles for Medical ResearchInvolving Human Subjects. Available from: www.wma.net/e/policy/b3.htm. Accessed May 6, 2005.3. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on theapproximation of the laws, regulations and administrative provisions of the Member Statesrelating to the implementation of good clinical practice in the conduct of clinical trials onmedicinal products for human use. Official Journal of the European Union 2001;121:34.4. FDA Regulations Relating to Good Clinical Practice and Clinical Trials. Available from:www.fda.gov/oc/gcp/regulations.html. Accessed May 6, 2005.5. Musen MA, Rohn JA, Fagan LM, et al. Knowledge engineering for a clinical trial advice system:uncovering errors in protocol specification. Bull Cancer 1987:74;291–6.6. Gennari JH, Weng C, McDonald D, et al. An ethnographic study of collaborative clinical trialprotocol writing. Medinfo 2004;11:1461–5.7. van der Lei J. What is in a protocol? An Invitational Workshop: Towards Representations forSharable Guidelines, March 3–4, 2000. Position Paper. Available from: www.glif.org/workshop/position_stmt/vanderLei.pdf. Accessed May 6, 2005.8. The Medicines for Human Use (Clinical Trials) Regulations 2004. Statutory Instrument 2004 No.1031. Available from: www.legislation.hmso.gov.uk/si/si2004/20041031.htm. Accessed May 6, 2005.9. Day S. Dictionary of Clinical Trials. Chichester: John Wiley & Sons, 1999.10. DeMets DL, Furberg CD, Friedman L, editors. Data Monitoring in Clinical Trials: A Case StudiesApproach. New York: Springer Verlag, 2005.36