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Epigenetics of Immunity in Cancer

SCIence outreach: The example of BIObanks in EUrope

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Eurac Research is a private research center​ based in Bozen-Bolzano. Our researchers come from a wide variety of scientific fields and all parts of the world.

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FACILITATE is a project built on a patient-centred, data-driven, technological platform where dynamic consent allows the returning of clinical trial data to study participants within a GDPR compliant and approved ethical framework. FACILITATE starts-off by providing clear rules in a trusted ethical, legal and regulatory ecosystem before engaging patients as data generators. This avoids the current situation where clinical data are siloed in separate repositories without any possibility to be used beyond their original single-sided purpose. FACILITATE will provide the technological solutions to comply with GDPR in medical research by building on the empowered stakeholders? willingness to share and re-use their data. The FACILITATE Consortium was constituted by drawing from a broad range of capacities to tackle the ambitious challenges related to future clinical trials, such as preventive, long-term and real-world evidence trials. The Consortium took an innovative approach to the data return to study participants by asking them what they needed to be implemented to feel in a trusted ecosystem. This required all Consortium participants to leverage on their existing networks to bring together stakeholders at all levels in the decision-making chain, including patients, healthcare professionals, software designers, clinical trials repositories processors and controllers, ethicists, lawyers and other active regulators. Having obtained a dynamic consent on the data portability FACILITATE will re-use and cross-reference them with those contained in other repositories including RWE data captured across multiple settings and devices. FACILITATE will last 4 years and will participate in the extended Pilot on Open Research Data of Horizon 2020. Its strategy represents a unique and innovative opportunity for medicines drug development and regulation to better understand the clinics of diseases, and to evaluate the effectiveness of products in the healthcare system.

https://facilitate-project.eu/

1.1 Objectives CLINICAL TRIALS REIMAGINED - PATIENT CENTRED – DATA DRIVEN The current availability of both qualitative and quantitative health data is unprecedented in the history of mankind (i.e., 2.5 quintillion bytes/day which means 1,7 Mb per person/per second from 200 Billion connected devices by the end of 2020). Soon technology-computing, connectivity and storage capacity will enable further availability of health data exponentially in two ways: increasing computerization and quantifying self and mobile-health.Both these advances have potential issues. The increased computerization of medical processes and procedures would need to provide means to link data to information and to knowledge in a virtuous interexchange while quantifying self and mobile-health, (i.e. the possibility for each person, healthy or not, to measure their medical condition through smartphones, wearable sensors and any other digitally reducible phenotypes) by becoming the primary source of health data that would need to be reconciled with data access, usage, portability, privacy and – in Europe – with GDPR compliance.The present proposal aims at addressing in a solution-based methodology both issues.The overall goal of this 4-years project is the development of a patient centred series of constituting the conceptual basis for a functional process prototype to allow the direct generation and the return of clinical trials data to study participants.By putting the study participants at the very core of their data portability and secondary use the FACILITATE project will make it easier to integrate both local and pan-European implementations considering best practices and data protection regulations.This prototype process will be delivered as part of the project alongside a robust business plan to ensure its sustainability to foster the harmonization of the legal framework applicable to medical research in different European Member States.RATIONALE The so called P4 or Precision Medicine: predictive, preventive, personalized, and especially participatory represents the cornerstones of a new model of clinical medicine, based on the convergence of three megatrends: the scientific and technological tools of systems medicine, the digital revolution and the patient’s involvement in their own health.This approach offers concrete opportunities to modify the current healthcare paradigm, and this is precisely what the FACILITATE project intends to achieve. According to such paradigm the participation variable involves the individual in strategies aimed to predict, prevent, and personalize the process of care, increases the individual’s confidence to shift from a passive receiver of care to an active, responsible, and aware driver of his/her wellness.A patient-oriented research is defined as one that is conducted with human subjects or on materials of human origin that can be linked with certainty to a specific individual. Such clinical research, drawing from multiple sources (structured or unstructured) of data represents a different kind of knowledge generated by increasing amount of valuable and highly variable data. At present, these highly valuable clinical and non-clinical data are stored in often incompatible and fragmented medical silos without any possibility to be used beyond their original single-sided purpose. To allow the sharing of these sensitive, health-related personal data in aPage 3 of 64 meaningful, ethical, and privacy-compliant environment, innovative legal, organizational and technical solutions are needed.However, EHRs and clinical trials records represent a considerable number of high-quality patients’ personal data. Lack of harmonization across already heavily regulated clinical trials domains including requirements imposed by European and national Ethics, Privacy and Data Protection legislations, renders “de facto” impossible for interested stakeholders such as first and foremost the same patients but also hospitals, academia, and industries, to share such personal data, enrich their records and gain additional knowledge and value from them.Consequently, patient data managed by pharma companies cannot be currently returned to patients neither (expect on rare specific cases) re-used for other research needs. To overcome this situation, it is necessary to build new and trusted ecosystems compliant with ethical and privacy clinical data sharing between different stakeholders. A first required step is to appreciate the added value of data re-utilization efforts towards interoperability, legal harmonization, and economic incentives. On the technological level, this translates into a series of challenges addressing not only the intellectual property management aspects, but also the adoption of medical informatics standards that could enable such sharing scenarios, as well as the underlying technology layers that could provide integration and interoperability between different medical information systems. In conjunction with the discrepancies in GDPR and ethical regulations implementation between Member States, this situation clearly constitutes a competitive disadvantage for clinical research in Europe.Over the past years, it appears that the share of clinical trials run in EU is decreasing while highly increasing in Asia (especially in Japan). The parallel with the relatively stable situation in the US which regulation enables an easier process for data sharing demonstrates the urgent need to define a clear and implementable process. An initiative such as the blue button project demonstrates the competitive advantage of the US in this respect. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4696090/). This analysis leads to the conclusion that the European Union highly competitive situation is undermined by the absence, when it comes to clinical trials, of a clear and common GDPR and ethically compliant process. It is of the highest importance to address this gap to avoid a more important loss of shares in the number of clinical trials run in the Member States, that would drive to:- A loss of economic opportunities for clinical research centres in EU, CROs and European pharma companies,- A loss of trust by patients and citizens in the medical system and the research processes as they do not get information of interest on their health status during the clinical trials. The inability to inform the patients on whether they were included in the control arm or whether they received the investigational drug also creates confusion and bad perception as the efforts and risks accepted by patients do not appear to be recognized.- A loss of research opportunities for all stakeholders and especially in the perspective of improving patients medical care by the limits of use of data that could help or guide future medical care, risk control and early diagnosis- A higher cost of health management as several tests realized in clinical trials cannot be communicated to HCP, potentially leading to a duplication of efforts and a loss of information on potential comorbidities,Additionally, the current standards in health and medicine are not universal, despite obvious benefits and significant effort made by existing interoperability activities such as European Electronic Health Record Exchange Format (EEHRxF), High Level 7 (HL7), OHDSI (Observational Health Data Science and Informatics), openEHR, and others. To adequately address the interoperability, privacy and visibility challenge, stakeholders need to be able to move their data focus from local, towards a network shared model, decentralized to some extent.Page 4 of 64 FACILITATE will build an Interoperability trusted Ecosystem that facilitates data governance models for clinical trial data using a set of technical interoperability processes that have been prototyped and validated in controlled environments and applied to data volumes within different clinical settings. FACILITATE will also focus on resolving the needs of the patients, using a structured process that converts an individual need or the most relevant/shared need from a pre-defined and agreed set of needs to a challenge. These challenges will be exposed by the FACILITATE model and resolved through a unique co-creation prototype process.MAIN OBJECTIVESThe main objective is the development of a new ethical, legal, and regulatory framework overcoming the current limitations and discrepancies between European Member States to enable the return of clinical trial data to study participants and other healthcare professionals involved in their care. The secondary objective is to build a prototype process enabling the re-use of those data for future research needs. Finally, the project intends to show that such processes are technically implementable.The success in reaching the above goals might enable the emergence of a new way for clinical trials data generation. This objective is in line with the HMA-EMA Joint Big Data Taskforce (2019) and with the European Medicines Agency (EMA) strategic reflection on Regulatory Science 2025 to which extensive and integral references are intentionally made throughout the present document. Additionally, FACILITATE will comply with the following sub-objectives:(i) Reinforce patient relevance in evidence generation;(ii) Modernize the GCP regulatory oversight to enable decentralized models of clinical trials coupled with direct digital data accrual;(iii) Definition of data governance models for clinical case use;(iv) Facilitate training and understanding of healthcare professionals and patients to access and participate effectively in such trials.These objectives will be reached starting from the needs and the requirements expressed by study participants themselves. The process to return data and the associated demonstration technological platforms will be built around the patients’ desiderata. We know that for research trials, enacting the GDPR had several immediate implications, both for sponsors, contract research organizations (CROs) and trial sites located in the European Union (EU), as well as for some foreign CROs and sponsors and, although the GDPR lays out overarching principles, it leaves it to member states to define how the research exemptions work in the national legal frameworks loosing, at the end, the patients’ most important perspective that it was set up to protect.Complete anonymization of personal research data has been considered as a possible mean to overcome some of the provisions foreseen by the GDPR, but – in turn - this directly impacted the quality of the datasets as well as the individual’s rights to receive even urgent medical results relevant for their health. Moreover, on the technical side, different interpretations of what constitutes appropriate anonymization exist. Even if subjects are not identified, their biological samples contain what some officials consider personally identifiable information anyway.So, in order to return clinical trial data to study participants within a GDPR compliant and ethically sound framework the prototype process should include specific notification enabling potential secondary uses for research purposes, in line with the Regulation and in respect with the legitimate interests of patients.The ultimate objective is to build a prototype process and the associated technical platform demonstrating its technical feasibility. Executing the concept strategy of the FACILITATE project will allow secondary processing of personal data obtained directly from the subjects themselves to populate existing or new clinical trials with additional evidence, under the ethical, legal and regulatory framework of the GDPR andPage 5 of 64 the CTR (Eu Regulation 536/2014). These rules notably outline a minimal list of information to be disclosed to the study participants, including:(i) the purpose and legal basis for such processing;(ii) the period for which such data will be stored; and(iii) whether the provision of such data is a statutory or a contractual requirement or is compulsory or non-mandatory. These clarifications will be provided in a concise, transparent, intelligible and easily accessible form, using clear and plain language approved by a board of experts in communication and patient’s education such as EUPATI. EURAC role is to lead the developemt of the ethical framework for the project Objectives.The ethical framework WP combines empirical and analytical approaches aimed at identifying, assess and design ways to respond to ethical and normative challenges concerning the return of data from clinical trials to study participants. The main objective of this WP is to develop a robust ethical framework to support the building of a prototype process for returning data from clinical trials to patients and develop recommendations within this framework of co-creation to include the interests of patients and stakeholders. The Framework provides the basis for the guiding documents and processes for returning clinical trial data to patients and patient data secondary use.WP3 will have an open and ongoing dialogue with the WP2 legal framework. The ethical standards defined within the co-creation strategy will be formally discussed and approved by the relevant decision boards that include regulators, representatives of the relevant authorities, and patients and subsequently extended to external relevant authorities and regulatory agencies for comments with emphasis on the identification of necessary safeguards, exceptions, and external oversight required within the application of the GDPR.[O3.1] Starting from existing standards the WP on Ethical framework will provide recommendations that will be incorporated in the resulting guidance documents related to return of clinical trial data to patients and the secondary use of data.[O3.2] Expert decision committees evaluation procedures[O3.3] Development of appropriate procedures to return data from clinical trials to patients within the ethical and legal framework; procedures will include an analysis of gaps and barriers regarding their implementation. Procedures will be evaluated in conjunction with WP2 to ensure legal compliance and informed by the input of stakeholders throughout the entire development phase.[O3.4] Empirical validation of the processes[O3.5] Standards for approval to be submitted to appropriate governing authorities and regulators

FACILITATE

15-16.03.2023

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FACILITATEself.__wrap_b(":R36coejlm:",1)

15-16.03.2023

Projects

Project

SENECA

Project

EPICIR

Project

SciBIoEU ELSI

Project

FACILITATE

view all

Institute's Projects

FACILITATE