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

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.

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.

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.

The facilitation of a scientific culture that is more transparent even at the operational level will hopefully augment translational process and probability of success.