A yet2 client seeks an e-Solution/software platform with or without human-based service element to help assess the suitability of patients for clinical trials. The e-Solution should aggregate relevant medical events and problems that a patient has experienced in the past up to the moment the patient is screened/pre-screened for a clinical trial. Electronic and paper-based records should be uploadable from all available clinically valid data sources collecting a patient’s data including: general practitioners, hospitals, pharmacies, specialists, medical devices etc. The solution should be able to automatically check the complete record against clinical trial patient inclusion/exclusion criteria. The e-Solution should also be updatable by clinicians with new data after a patient has been enrolled in a trial. The ability to conduct remote patient history assessment (without requiring that the patient be physically available) is also desirable.
When selecting appropriate candidates for clinical trials, researchers require a wholistic and comprehensive account of all medical history (e.g visits, procedures and test results, and medications) a person has experienced in the past through present. A medical history is used by clinical investigators to determine a patient’s eligibility to participate in a particular clinical trial and is an important tool in the ongoing management of the patient.
Electronic Medical Records (EMR), a digital version of a patient’s chart, and Electronic Health Records (EHR), a repository of patient records across multiple doctors, begin to address the problem, but in many cases a unified and complete health record does not exist or is not easily accessible. Rather patient data is siloed within multiple health care provider networks (e.g. Medical System A data is not sharable with Medical System B). And when patients request their data to be shared it often must be faxed or mailed from one health system to the other.
Apps which allow patients to aggregate and share health data for their own purposes may be in scope if the data compiled is from heath care professionals (e.g. doctor, nurse, pharmacist) and NOT patient self-recorded data. Apps which help manage single chronic conditions such as diabetes are too limited in scope.
Therefore yet2’s client is seeking a patient medical history/data aggregation platform designed with the clinician, and ideally clinical trials or research in mind.
- Uploads EMR/EHR patient data to the EDC (Electronic Data Capture)
- Uploads third party data such as prescription data, lab data, insurance data
- Supports scanning, classifying, and cataloging of collected patient medical history data
- Checks aggregated data against patient inclusion/exclusion criteria
- Allow data corrections/changes/amending by the investigator
- Meets data protection regulations in regions of operation (HIPPA, GDPR, etc.) for patient consent etc.
- Validated for clinical research
- Be adaptive to specific disease areas
- Be compatible with health systems across regions of operation
- Commercially available
- Audit trail required
- Globally accepted solution
- Supports ingestion of patient medical history data going back 10 years or more
- Ability to conduct remote patient history assessment (without requiring that the patient be physically available)
- Supports medical device data
- Supports other patient generated data when available such as activity level, eating habits, genomics, etc.
- Fuses disparate healthcare data sources into unified patient health overview classifying key-information
Possible Solution Areas
- Solutions collecting and interpreting data for consumers in medical devices, consumer healthcare, and/or pharmaceutical fields.
- Solutions that aggregate disparate healthcare data sources.
Desired Outcome of the Solution
A validated solution for clinical research.
Field of Use and Intended Applications
Clinical trial patient assessment and tracking.