Title |
The use of mechanistic evidence in drug approval
|
---|---|
Published in |
Journal of Evaluation in Clinical Practice, June 2018
|
DOI | 10.1111/jep.12960 |
Pubmed ID | |
Authors |
Jeffrey K. Aronson, Adam La Caze, Michael P. Kelly, Veli‐Pekka Parkkinen, Jon Williamson |
Abstract |
The role of mechanistic evidence tends to be under-appreciated in current evidence-based medicine (EBM), which focusses on clinical studies, tending to restrict attention to randomized controlled studies (RCTs) when they are available. The EBM+ programme seeks to redress this imbalance, by suggesting methods for evaluating mechanistic studies alongside clinical studies. Drug approval is a problematic case for the view that mechanistic evidence should be taken into account, because RCTs are almost always available. Nevertheless, we argue that mechanistic evidence is central to all the key tasks in the drug approval process: in drug discovery and development; assessing pharmaceutical quality; devising dosage regimens; assessing efficacy, harms, external validity, and cost-effectiveness; evaluating adherence; and extending product licences. We recommend that, when preparing for meetings in which any aspect of drug approval is to be discussed, mechanistic evidence should be systematically analysed and presented to the committee members alongside analyses of clinical studies. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 3 | 60% |
Australia | 1 | 20% |
Unknown | 1 | 20% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Practitioners (doctors, other healthcare professionals) | 3 | 60% |
Members of the public | 2 | 40% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 32 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 5 | 16% |
Student > Ph. D. Student | 4 | 13% |
Student > Master | 3 | 9% |
Student > Doctoral Student | 1 | 3% |
Lecturer | 1 | 3% |
Other | 5 | 16% |
Unknown | 13 | 41% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 4 | 13% |
Biochemistry, Genetics and Molecular Biology | 4 | 13% |
Philosophy | 3 | 9% |
Nursing and Health Professions | 2 | 6% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 3% |
Other | 4 | 13% |
Unknown | 14 | 44% |