Table 1.
Conclusions and recommendations for the implementation of P3PT based on community feedback analysis
| Area | Conclusion/recommendation | Benefit |
|---|---|---|
| P3PT implementation | Careful and stepwise implementation recommended | Widespread acceptance more likely |
| Initial preclinical multicenter studies should be performed by experienced centers, ideally having a long-standing history of collaboration | Swift and exact estimation of P3PT benefit under practical conditions | |
| P3PT organization and governance | Centralized study governance and central study protocol | Clinical-trial like design, enhanced result comparability |
| Core endpoints addressed by all centers according to P3PT protocol | Enhanced statistical power and higher predictability for primary endpoints | |
| Additional: individual endpoints addressed by single centers with outstanding competencies | Broad spectrum of translationally endpoints addressable (but no benefit for study power) | |
| P3PT animal models | Use of multiple models, if applicable | Better representation of patient population (polypharmacy, age, sex, comorbidities) |
| Use of large animal models, if available | Reflecting gyrencephalic brain structure, closer similarity to human situation | |
| P3PT quality assurance | Further enhancing awareness for those (might require institutional support [9]) | Increasing scientific rigor and result comparability, reducing divergences in relevance acknowledgment throughout the community |
| Strict application of quality assurance criteria | Enhanced result comparability and relevance | |
| P3PT financing and result publication | Establishing and recruiting of global funds | International and -continental collaboration facilitated, reduced financial burden for national public funding authorities |
| Early enrolment of high-quality academic-industry collaborations | Timely involvement of key stakeholders, preventing failure of clinical trials, bolstering financial resources for P3PT | |
| Establishing centralized writing committees | More efficient workflow, comparability to large scale clinical trials |