Clinical trials are formal investigations conducted to determine the effectiveness and safety of new drugs, biologics, chemical substances, mixtures, diagnostics, therapy protocols and medical devices. R&D studies address similar preliminary study objectives.
Typically clinical trials enroll volunteers or patients in controlled studies that compare new drugs, procedures or devices with their existing counterparts. Clinical trials vary in size and scope.
Clinical trials can be either observational in nature (intended to observe subjects and measure outcomes associated with treatment) or interventional (specific medicines or treatments are provided).
With the exception of small trials in a single location, the objectives and procedures to be employed in the clinical trials are formally presented in a clinical trial protocol document. This document insures that all procedures and tests related to the clinical trial are performed in a consistent manner.
Clinical trials can be classified by purpose:
- Prevention trials
- Screening trials
- Diagnostic trials
- Treatment trials
- Quality of Life trials
- Compassionate use trials
The ADRM Clinical Trials data models provide an integrated information architecture supporting the planning and reporting of clinical trials data:
| Protocol Report | Documentation |
| Clinical Study Report | Peer Review |
| Objectives | Drug |
| Procedures | Device |
| Patient / Disease Characteristics | Recruitment |
| Protocol Amendments | Individual / Patient |
| Clinical Trial Tests | Adverse Event |
| Sponsor |
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