A brief introduction to clinical research, from James Lind’s scurvy investigation in 1747 to today.
There are several types of clinical trial designs: randomised or non-randomised controlled trials, single or double blinded trials, and superiority or non-inferiority trials.
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.
Compensation in clinical trials is not always a standard but may be offered to participants according to different models and in line with the respective legislation and regulations.
When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability, methodology, results, discussion, significance, and conclusions of the study.
The four phases of clinical development are explained in terms of objectives and features.
When women of childbearing potential are included in clinical trials, safety precautions must be taken in order to avoid the unintentional exposure of an embryo or fetus to the candidate medicine before adequate reproduction toxicity data are available.
The value of clincal trial results is assessed in light of its design, its participants, the observed effects, and previous medical knowledge.
Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes into the public domain via a number of routes.
Clinical trial results are statistically analysed in terms of demographics, efficacy, and safety. Different types of clinical trial may warrant different interpretations of trial results.