The practice of experimental studies in psychopharmacology: Top 10 tips from one centre's experience.

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.