Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 314 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | 21 CFR Part 314 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 314 Applications for FDA Approval to Market a New Drug https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.7 |
| Scope | HM |
| Document part | § 314.126 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Study design, Placebo, Requirements, Objective |
Content
§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been developed over a period of years and are recognized by the scientific community as the essentials of an adequate and well-controlled clinical investigation. The Food and Drug Administration considers these characteristics in determining whether an investigation is adequate and well-controlled for purposes of section 505 of the act. Reports of adequate and well-controlled investigations provide the primary basis for determining whether there is “substantial evidence” to support the claims of effectiveness for new drugs. Therefore, the study report should provide sufficient details of study design, conduct, and analysis to allow critical evaluation and a determination of whether the characteristics of an adequate and well-controlled study are present. (b) An adequate and well-controlled study has the following characteristics: (1) There is a clear statement of the objectives of the investigation and a summary of the proposed or actual methods of analysis in the protocol for the study and in the report of its results. [...] (2) The study uses a design that permits a valid comparison with a control to provide a quantitative assessment of drug effect. [...] (i) Placebo concurrent control [...] (ii) Dose-comparison concurrent control [...] (iii) No treatment concurrent control. [...] (iv) Active treatment concurrent control [...] (v) Historical control [...] (3) The method of selection of subjects [...] (4) The method of assigning patients to treatment and control groups [...] (5) Adequate measures are taken to minimize bias [...] (6) The methods of assessment of subjects' response are well-defined and reliable. [...] (7) There is an analysis of the results of the study adequate to assess the effects of the drug [...]
