The field of clinical research is large and many different business use cases (BUC) would benefit of being studied in the xShare project. A global list of 10 BUC has been suggested with focus on real-world data items of greatest value to clinical research and proposals for a research extension to the IPS (IPS+):
- 1 Patient pre-screening in clinical trial through healthcare professional pre-screening tool
- 2 Patient self-nomination as possibly eligible for a trial
- 3 Protocol feasibility via a repository of IPS+ summaries, e.g. at hospital, regional or national level
- 4 Targeted patient recruitment via a repository of IPS+ summaries, e.g. at hospital, regional or national level
- 5 Clinical Study support – whole scenario (side effect reporting)
- 6 Longitudinal cohort tracking
- 7 Clinical Study definition
- 8 Clinical Study follow-ups
- 9 Site feasibility guided by xShare button
- 10 eCRF Filling Process through xShare Button
A more detailed description of each use cases is available below:
1 Patient pre-screening in clinical trial through healthcare professional pre-screening tool
In this use case, the xShare Button is activate by the patient to share data from IPS+ to a pre-screening software. This pre-screening tool is used by HCPs at site, which consists in answering a short medical questionnaire filtering automatically the right clinical trials according to the patient profile. The workflow with the xShare Button would start with the patient sharing data thanks to the xShare Button allowing the patient data uploaded into the prescreening tool. Then, according to the available data, answers to the medical questionnaire are automatically fulfilled and the physician reviews the answers provided, and answers the questions left without answer. The prescreening tool indicates the studies for which the patient is potentially eligible for and the physician selects one or more studies for which he wants to refer the patient. A notification is sent to the study team to facilitate the coordination onsite for future patient inclusion.
2 Patient self-nomination as possibly eligible for a trial
In this use case, the patient can download their summary via the xShare Button, especially if this is the IPS+. An app on their smart device scans online (computable) trial eligibility criteria in their country and offers the patient a suggestion for a trial that is openly recruiting and for which they may be eligible. It offers the patient a contact channel (email, phone etc.) if the patient wishes to enquire about enrollment.
3 Protocol feasibility via a repository of IPS+ summaries, e.g. at hospital, regional or national level
This BUC assumes that the xShare IPS+ stimulates greater investments in having good quality summaries, implementing the necessary EHR system interoperability and investing in clinical data repositories with populations of such summaries. These might be intended for patient care (primary use) but could easily be queried anonymously to implement the original EHR4CR use case of profiling patient numbers against candidate eligibility criteria, to establish the feasibility of the study and to refine the criteria to maximize the chances of good recruitment. Federated querying would enable the scalability of the insights.
4 Targeted patient recruitment via a repository of IPS+ summaries, e.g. at hospital, regional or national level
This BUC also utilizes one or more repositories of IPS+ summaries. It assumes that a final recruitment query on a study could be executed by authorized persons to extract a candidate list of patients who might be eligible. This list might feed into an electronic pre-screening or be used as a direct invitation list to contact patients and invite them to consider participation.
5 Clinical Study support – whole scenario (side effect reporting)
A clinical study is defined to assess the prevalence of reported side effects and their association with disease and drug characteristics in patients with chronic hypertension.
Inclusion criteria are: 1) age > 18 years, 2) history of hypertension and therapy with anti-hypertensive drugs, 3) ability to provide informed consent.
At enrolment, patients will be asked to fill a study questionnaire focused on the perceived side effects of antihypertensive medications on an application. The Patient’s app enables the xShare Button when all the required information are ready, and clicking on the xShare Button the patient create the research dataset, in the EEHRxF format, or IPS if applicable and send it to the research center that is leading the investigation, applying anonymization/pseudonymization/identified-patient criteria as defined in the clinical study.
Main Pre-condition: granted consent from the patient to collect data in the patient’s app, clinical study approved by the reference ethical committee, candidate patient selected with the anonymous application of the selection criteria with no data shared with research center, patient informed consent document describes P.I. and research sponsors, benefits, length of the study, data management.
Main Post-Condition: without explicit permission data can be used only for the clinical protocol granted by the patient with his/her consent. Another protocol requires another explicit permission.
6 Longitudinal cohort tracking
In this BUC, an HCP agreed to maintain a list of patients with a particular disease and uses the IPS+ as a data set to maintain a pseudonymised data warehouse with this data (or can generate it just in time on demand). This provides a permanently available longitudinal natural history study and virtual study recruitment pool.
7 Clinical Study definition
After the authorization granted for the execution of a clinical study (ethical committee), it is needed to configure the different clinical IT systems, corresponding to the different source of data, to select the right candidates having the information required, considering also retrospective information, and having a match on selection criteria.
This can be expressed in a processable FHIR bundle, describing the eCRF in a structured format, and applicable as a filter or data input guide usable in EHR, PHR systems or IPS+ repositories
The candidate list represents the basis for further processing, or actions in case of patient’s consent submission for each candidate (when required).
8 Clinical Study follow-ups
In this use case, a clinical study requires the periodic compilation of a questionnaire (i.e. every week or every 6 months, etc.). In a specific section of a patient App/portal there is a reminder to do it, and a link that forwards to the questionnaire. The patient compiles the questionnaire and at the end press on the xShare Button to send the questionnaire (anonymized/pseudonymized according to the study design) to the reference research center (or Dataspace/repository). The questionnaire can be represented in EEHRxF using FHIR resources (Questionnaire/ QuestionnaireResponse) or embedded in IPS+.
9 Site feasibility guided by the xShare Button
This BUC also utilizes one or more repositories of IPS+ summaries. This BUC aims to use the xShare Button to assess site feasibility. Site selection is a major challenge to ensure the success and relevance of a clinical study. Indeed, recruiting an adequate number of subjects is the most challenging part of conducting a clinical trial for data analysis. Sites must be selected in accordance with their patients, and the number of sites participating in the clinical trial must be determined based on each site’s recruitment capacity. Data shared from IPS+ through the xShare Button will provide crucial information to qualify each center’s population.
In this use case, patients share their data with the xShare Button. Data is analyzed in several dashboards and can provide an overview of the types of patients being monitored in an area: sites can be selected based on precise data regarding the patients being monitored. Then Sponsor/CRO can gain access to dashboards and identify the relevant sites for their clinical trial and sites can gain access to dashboard and identify which clinical trial are the most compliant with their practice and patient populations.
10 eCRF Filling Process through the xShare Button
The patient included in a clinical trial shares his/her data using the xShare Button to complete the eCRF. The patient is registered as being part of the clinical trial, which establishes the data link needed from the IPS+ to the eCRF. A mapping is performed from core data elements to the eCRF and the patient can share data related to exams performed between visits, such as: in-town biology, concomitant treatments, and self-questionnaires. The patient can share data to monitor ongoing adverse events and actions taken (treatment, other visits to health providers, etc.). The patient can share data from medical devices linked to an app using the xShare Button
