Periodic Reporting for period 1 - PSY-PGx (A New Intervention for Implementation of Pharmacogenetics in Psychiatry)
Okres sprawozdawczy: 2021-03-01 do 2022-08-31
Nowadays, ~30% of the population will suffer from a mental illness at least once in their lifetime. Due to the chronic relapsing nature of mental disorders and increased life expectancy, the societal burden of mental disorders is likely to increase even further. Effective treatments for mental disorders are available, but their effect is limited due to patients’ (genetic) heterogeneity and low treatment compliance due to frequent side effects; only one-third of the patients respond to treatment and experience remission. Today, medication selection in psychiatry relies on a trial-and-error approach that combines physicians’ experience with clinical indicators.
Recent studies have shown that genotyping of gene-encoding drug-metabolising enzymes can increase the effectiveness of treatment, which could benefit millions of patients. Pharmacogenetic testing can help reduce uncertainty in this process by determining the person-specific genetic factors that predict clinical response and side effects associated with genetic variants that impact drug-metabolising enzymes, drug transporters or drug targets. Personalised medicine) has the potential to respond to mental disorders and the increasing burden of co-morbidities, thus enhancing the sustainability of healthcare systems.
To this end, a newly developed algorithm will be created based on available biobank data from Finland and the UK, with the aid of Artificial Intelligence. Also, a PSY-PGx clinical trial will be performed, which is the first international, multicentric, non-industry sponsored trial of the utility of pharmacogenetic-based treatment personalization in psychiatry. The results of the clinical trial will be used to validate and finetune the algorithm. It will deliver a new, economically viable model of care for sustainable healthcare systems.
Recent studies have shown that genotyping of gene-encoding drug-metabolising enzymes can increase the effectiveness of treatment, which could benefit millions of patients. Pharmacogenetic testing can help reduce uncertainty in this process by determining the person-specific genetic factors that predict clinical response and side effects associated with genetic variants that impact drug-metabolising enzymes, drug transporters or drug targets. Personalised medicine) has the potential to respond to mental disorders and the increasing burden of co-morbidities, thus enhancing the sustainability of healthcare systems.
To this end, a newly developed algorithm will be created based on available biobank data from Finland and the UK, with the aid of Artificial Intelligence. Also, a PSY-PGx clinical trial will be performed, which is the first international, multicentric, non-industry sponsored trial of the utility of pharmacogenetic-based treatment personalization in psychiatry. The results of the clinical trial will be used to validate and finetune the algorithm. It will deliver a new, economically viable model of care for sustainable healthcare systems.
The first reporting period has been fully dedicated to preparation.
WP1 was designed for setup and preparation:
-WP1A has developed the logistics behind the genotyping, the analyses and the reporting results for the PSY-PGx clinical study.
-WP1B has prepared and designed everything for thePSY-PGx clinical study.
-WP1C was initiated to provide a good IT structure, and to implement the BeHapp app into the clinical study.
WP2, the ELSI WP, has provided input for regulatory and ethical information with respect to the PSY-PGx project, and is preparing to assess the societal impact of pharmacogenetics in psychiatry.
WP3, the Data Management WP, has set-up the data flow and put together a detailed data Process Flow. Also the Data Management Plan was set-up, adjusted some times and the EDC (in Castor) for the clinical study was set-up.
WP4, the Biobank WP, has applied for Biobank data in Finland and the UK, and is currently making sure that the data can be assessed, in a FAIR way.
WP5, the Clinical WP, has taken over from WP1B in preparing for the clinical study. IRB approval has been obtained in some countries (NL and Serbia) and is ongoing in the others. First patient in was Feb 2023 at Amsterdam.
WP6, the technical WP, that will set-up the algorythm, is waiting for data to become available and accessible.
WP7, the Dissemination WP, has undertaken several activities:
-The website was designed: www.PSY-PGx.org and also a Dutch version was set-up by the Amsterdam team (www.PSY-PGx.nl );
-Several workshops/discussion groups and lectures were orgsanised, and the Proect Coordinator and WP Dissemination Lead are in close contact with GAMIAN to involve the patients in dissemination.
-The Dissemination and Outreach Plan has been accepted by the General Assembly.
WP8, the Project Management WP, has ensured that all project bodies and boards have been established (coordinated by the Scientific Coordinator) and confirmed by the Executive Board and the General Assembly.
-Specific project plans, such as risk plans, quality assurance plans, data management plans have been drafted by the project manager and Scientific Coordinator, internally reviewed, and accepted by the appropriate bodies.
-Progress of the preparations has been ensured and documented via the Milestones and Deliverables.
-Meetings have been organised, such as the Executive Board Meets (2x/year), the General Assembly, once yearly) the Workpackage Leader meets (bimonthly), and interdisciplinary workpackage meetings (first 1,5 years biweekly, later 1x/month).
-The Consortium Agreement has been executed.
-Sub-agreements have been initiated to arrange the clinical study, the material and data transfers and data processing between partners. This is an ongoing process.
WP1 was designed for setup and preparation:
-WP1A has developed the logistics behind the genotyping, the analyses and the reporting results for the PSY-PGx clinical study.
-WP1B has prepared and designed everything for thePSY-PGx clinical study.
-WP1C was initiated to provide a good IT structure, and to implement the BeHapp app into the clinical study.
WP2, the ELSI WP, has provided input for regulatory and ethical information with respect to the PSY-PGx project, and is preparing to assess the societal impact of pharmacogenetics in psychiatry.
WP3, the Data Management WP, has set-up the data flow and put together a detailed data Process Flow. Also the Data Management Plan was set-up, adjusted some times and the EDC (in Castor) for the clinical study was set-up.
WP4, the Biobank WP, has applied for Biobank data in Finland and the UK, and is currently making sure that the data can be assessed, in a FAIR way.
WP5, the Clinical WP, has taken over from WP1B in preparing for the clinical study. IRB approval has been obtained in some countries (NL and Serbia) and is ongoing in the others. First patient in was Feb 2023 at Amsterdam.
WP6, the technical WP, that will set-up the algorythm, is waiting for data to become available and accessible.
WP7, the Dissemination WP, has undertaken several activities:
-The website was designed: www.PSY-PGx.org and also a Dutch version was set-up by the Amsterdam team (www.PSY-PGx.nl );
-Several workshops/discussion groups and lectures were orgsanised, and the Proect Coordinator and WP Dissemination Lead are in close contact with GAMIAN to involve the patients in dissemination.
-The Dissemination and Outreach Plan has been accepted by the General Assembly.
WP8, the Project Management WP, has ensured that all project bodies and boards have been established (coordinated by the Scientific Coordinator) and confirmed by the Executive Board and the General Assembly.
-Specific project plans, such as risk plans, quality assurance plans, data management plans have been drafted by the project manager and Scientific Coordinator, internally reviewed, and accepted by the appropriate bodies.
-Progress of the preparations has been ensured and documented via the Milestones and Deliverables.
-Meetings have been organised, such as the Executive Board Meets (2x/year), the General Assembly, once yearly) the Workpackage Leader meets (bimonthly), and interdisciplinary workpackage meetings (first 1,5 years biweekly, later 1x/month).
-The Consortium Agreement has been executed.
-Sub-agreements have been initiated to arrange the clinical study, the material and data transfers and data processing between partners. This is an ongoing process.
PSY-PGx enables patients with mental illness to receive personalised treatment. The phenotyping and genetic analysis components of PSY-PGx contribute to personalising diagnosis and treatment and making disease and outcome predictions for patients more accurate, thereby reducing the risk of ‘hit-and-miss’ medications and the financial burden of incorrect medications.
The assessment of genetic and continuous tracking of physical data will also help reduce the risk of drug-drug interactions with potential hazardous outcomes as e.g. the development of comorbidities as cardiovascular disease (cardiac rhythm disorders, hypertension, glucose intolerance, diabetes, adipositas) or behavioural disturbances as increase in suicidal thoughts or behaviour or increase in agitation. Through the PSY-PGx new model, patients will become more aware of their personal risk factors and their own behaviour and how this influences their condition and treatment. They will have closer contact with clinicians and feel more involved in their treatment.
Additionally, the knowledge and analysis of behavioural aspects, especially lifestyle choices, will help them identify factors which might positively influence their treatment and recovery. The open methodology policies applied to PSY-PGx will further enable patients to be informed on the different aspects of the model of care (genotyping, phenotyping, data management).
The assessment of genetic and continuous tracking of physical data will also help reduce the risk of drug-drug interactions with potential hazardous outcomes as e.g. the development of comorbidities as cardiovascular disease (cardiac rhythm disorders, hypertension, glucose intolerance, diabetes, adipositas) or behavioural disturbances as increase in suicidal thoughts or behaviour or increase in agitation. Through the PSY-PGx new model, patients will become more aware of their personal risk factors and their own behaviour and how this influences their condition and treatment. They will have closer contact with clinicians and feel more involved in their treatment.
Additionally, the knowledge and analysis of behavioural aspects, especially lifestyle choices, will help them identify factors which might positively influence their treatment and recovery. The open methodology policies applied to PSY-PGx will further enable patients to be informed on the different aspects of the model of care (genotyping, phenotyping, data management).