TY - JOUR
T1 - The practice of experimental studies in psychopharmacology
T2 - Top 10 tips from one centre's experience
AU - Mazibuko, Ndaba
AU - Mehta, Mitul A.
PY - 2018
Y1 - 2018
N2 - Objective: Recent efforts to optimise translation of basic research findings to successful clinical trials have led to a sharper focus on experimental medicine translational studies. This is coupled with a movement towards greater methodological integrity and openness. Although this can be achieved through preregistration and detailed reporting of study methodology, the reality of study application can often be lost. Methods: In practice, challenges in study application can often lead to diminished scientific robustness, even in well-designed studies. A detailed description of experiences is essential for learning and subsequent improvement. To this end, the authors undertook a description of the experience of a specialised psychopharmacology experimental study centre. Results: This centre's experiences reveal that even supposedly routine study elements, such as screening parameters, peri-drug administration, and peri-discharge procedures, can pose significant practical obstacles to the achievement of minimal protocol deviation. Ultimately, these factors impact on academic standards such as enhanced data reliability; but they have additional implications for participant clinical safety and well-being, for instance in relation to adverse event and incidental finding recording. Conclusions: The facilitation of a scientific culture that is more transparent even at the operational level will hopefully augment translational process and probability of success.
AB - Objective: Recent efforts to optimise translation of basic research findings to successful clinical trials have led to a sharper focus on experimental medicine translational studies. This is coupled with a movement towards greater methodological integrity and openness. Although this can be achieved through preregistration and detailed reporting of study methodology, the reality of study application can often be lost. Methods: In practice, challenges in study application can often lead to diminished scientific robustness, even in well-designed studies. A detailed description of experiences is essential for learning and subsequent improvement. To this end, the authors undertook a description of the experience of a specialised psychopharmacology experimental study centre. Results: This centre's experiences reveal that even supposedly routine study elements, such as screening parameters, peri-drug administration, and peri-discharge procedures, can pose significant practical obstacles to the achievement of minimal protocol deviation. Ultimately, these factors impact on academic standards such as enhanced data reliability; but they have additional implications for participant clinical safety and well-being, for instance in relation to adverse event and incidental finding recording. Conclusions: The facilitation of a scientific culture that is more transparent even at the operational level will hopefully augment translational process and probability of success.
KW - experimental medicine
KW - psychopharmacology
KW - study implementation
UR - http://www.scopus.com/inward/record.url?scp=85054617742&partnerID=8YFLogxK
U2 - 10.1002/hup.2674
DO - 10.1002/hup.2674
M3 - Review article
C2 - 30306672
AN - SCOPUS:85054617742
SN - 0885-6222
VL - 33
JO - Human Psychopharmacology
JF - Human Psychopharmacology
IS - 5
M1 - e2674
ER -