In the current Clinical Trials Directive, the definition of conditions for inclusion of vulnerable populations is limited to clinical trials with minors and incapacitated adults who are not able to give informed legal consent. Released in April 2014, the new “EU Clinical Trial Regulation” (EU Regulation 536/2014) expands on information given for the above populations. Additionally, it also goes further and defines the conditions, especially the informed consent process for clinical trials in pregnant and breast feeding women as well as in emergency situations. Although, the objective is to harmonise the performance of clinical trials in Europe, certain opt-out options for Member States are foreseen and thus might lead to exclusion of certain countries from some trials.
A brief introduction to clinical research, from James Lind’s scurvy investigation in 1747 to today.
Adaptive designs in clinical trials are relatively flexible designs that allow for modifications during the trials.
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.