We achieved the following steps in the second reporting period:
All preparatory steps were taken to ensure that all data and samples of the clinical study could be processed as needed (WP1). Even though we experience delays in the related administration at some recruitment sites, initial recruitments could start. Three of our partners are currently enrolling patients. Several actions have been taken to stimulate patient recruitment further and allow the data collection to proceed as planned once all centres can start recruiting (WP5). PSY-PGx puts great emphasis on ethical, legal and societal issues (WP2) and actions to support this are progressing as planned. The study and data management (WP3) activities have led to all associated SOPs and data collection systems being established. Continuous fine-tuning has allowed the harmonization of data between centres. We are continuously monitoring the progress of our data management systems. The processing of the biobank data (WP4) was delayed as the signing of all biobank agreements took longer than expected but the related data processing activities are expected to now lift off with all approvals being obtained. The effects of CYP2C19 genotype on proxies of SSRI antidepressant response could already be investigated based on the transferred data, with the data being published open access. Due to the delays in the data transfer agreements, the algorithm to set-up the medication modelling could not be finalized yet but an initial approach has been developed (WP6). The dissemination and exploitation activities are strongly advancing, with a major milestone of the project being achieved ahead of schedule: In September 2023, the international guideline on the use of PSY-PGx in Psychiatry was presented at the World Psychiatric Association Congress (WP7). PSY-PGx has been involved in various outreach activities such as international lectures, training programmes, webinars, keynote sessions and patient events. Project management (WP8) is proceeding through various coordinating meetings, with several important administrative steps being taken in RP2 (see below).
The main results achieved during RP2 were:
- Finalization of the clinical study protocol was achieved,
- Ethical approval was obtained for PGB, MUMC, FFUB, UBB and KCL,
- The User satisfaction analysis report of the BEHAPP application was completed,
- The Processing of eCRF in CASTOR has been completed,
- SOPs for (pseudo-)anonymization are in place,
- All data harmonization strategies are established,
- The DMP has been adapted based on initial feedback,
- Approval documents for involved biobanks have been arrnaged for the UK Biobank and are being arranged for the Finish Biobanks (7),
- An open-access publication based on the biobank data has been published,
- The trial registration has been added to the WHO registry network,
- Several boards (Executive Steering Board, Scientific and Ethics Advisory Board, Patient Advisory Board, Data Access Committee) were established,
- A governance report was submitted,
- A consortium agreement was signed, including NDAs with external advisors and third-party contracts,
- A quality assurance plan has been developed,
- A risk contingency plan has been set up and adjusted
