or is performed to understand the relative efficacy
and safety of drugs compared to other newly
available marketed medicines of the same class
or of other classes also used for the same indica-
tion, such studies can have extremely high-value
public health value. Finally, the ability to pool
data sets, conduct specific outcomes research,
assess real-world use, benefit–risk and pharma-
coeconomics, critical for formulary and access
decisions, makes thesedepartments indispensa-
ble to pharmaceutical companies and clinicians
who depend on an ongoing stream of clinical
data.
Further reading
Anderson DL. 2004.A Guide to Patient Recruitment
and Retention. Thompson Centerwatch: Boston,
MA.
Food and Drug Administration. 2001.Code of Federal
Regulations (21 CFR), Parts 11, 50, 54, 56, 312, 314,
1st edition. Brookwood Medical Publications.
Friedman LM, Furberg CD, DeMets DL. 1998.Funda-
mentals of Clinical Trials, 3rd edition. Springer-
Verlag New York, Inc.: New York.
Hulley SB, Cummings SR, Browner WS, Grady D,
Hearst N, Newman TB. 2001.Designing Clinical
Research, an Epidemiologic Approach–Second
Edition. Lippincott Williams & Wilkins: New York.
International Conference on Harmonization. 1997.ICH
Harmonised Tripartite Guideline for Good Clinical
Practice, 2nd edition. Brookwood Medical
Publications.
Meinert CL, Tonascia S. 1986.Clinical Trials. Design,
Conduct and Analysis, Vol. 8. Oxford University
Press.
Munro Hazard B. 2005.Statistical Methods for Health
Care Research, 5th edition. Lippincott Williams &
Wilkins: Boston.
Piantadosi S. 2005.Clinical Trials: a Methodologic
Perspective, 2nd edition. John Wiley & Sons, Inc.
Spriet A, Dupin-Spriet T. 1994.Good Practice of
Clinical Drug Trials, 3rd edition. Karger.
Stephenson H. 2005.Strategic Research, a Practical
Handbook for Phase IIIB and Phase IV Clinical
Studies. Quintiles Transnational Corporation:
Research Triangle Park, NC.FURTHER READING 527