A clinical trial is one type of clinical research where a procedure or drug is intentionally administered outside the realm of standard medical practice to human subjects with the aim of studying its effect on the human body. This includes medications, operations, psychotherapy, physiotherapy, rehabilitation, nursing, restricted diets, and the use of medical devices. The comparative study of two or more treatments, involving the random assignment of treatments to patients, is considered a clinical trial even if the study includes approved drugs or medical devices. This means that a clinical trial is an experiment which includes human subjects. It is necessary to distinguish clinical trials from observational studies which collect outcomes when executing a study treatment as an ordinary treatment.
Since clinical trials include human subjects, the ethical aspects, i.e., the rights, safety and well-being of individual research subjects, should take precedence over all other interests at...
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References and Further Reading
Bretz F, Koenig F, Brannath W, Glimm E, Posch M (2009) Adaptive designs for confirmatory clinical trials. Stat Med 28:1181–1217
Gent M, Sackett DL (1979) The qualification and disqualification of patients and events in long-term cardiovascular clinical trials. Thromb Hemosta 41:123–134
ICH Steering Committee (1995) ICH harmonised tripartite guideline structure and content of clinical study reports. Recommended for adoption at Step 4 of the ICH Process on 30 November 1995
ICH Steering Committee (1996) ICH Harmonized tripartite guideline. Guideline for good clinical practice. Recommended for adoption at step 4 of the ICH process on 1 May 1996
ICH Steering Committee (1997) ICH Harmonized tripartite guideline. General considerations for clinical trials. Recommended for adoption at step 4 of the ICH process on 17 July 1997
ICH Steering Committee (1998) ICH Harmonized tripartite guideline. Statistical principles for clinical trials. Recommended for adoption at step 4 of the ICH process on 5 February 1998
ICH Steering Committee (2000) ICH Harmonized tripartite guideline. Recommended for adoption at step 4 of the ICH process on 20 July 2000
Jennison C, Turnbull BW (2000) Group sequential methods with applications to clinical trials. Chapman & Hall/CRC, Boca Raton
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World Medical Association (1964) Declaration of Helsinki. Ethical principles for medical research involving human subjects 1964. Amended by the 59th WMA General Assembly, Seoul, Korea 2008, http://www.wma.net/
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Uesaka, H. (2011). Clinical Trials: An Overview. In: Lovric, M. (eds) International Encyclopedia of Statistical Science. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-04898-2_11
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