By Ruchi Jhonsa, Ph.D.
Curebase, a distributed CRO startup, strives to achieve its mission of delivering medical innovations to patients by offering remote clinical research services. Building on the previous experiences gained from conducting FDA-grade, virtual trials in irritable bowel syndrome, cardiac rehab, smoking cessation, and women’s health, the company has now ventured into “at home” clinical trials for COVID-19.
The arrival of COVID-19 has impeded the progress of numerous clinical trials worldwide. Although scientists have embarked on multiple avenues to overcome this pandemic, the road to recovery is arduous due to the lack of a potent cure coupled with the non-availability of comprehensive patient data.
Besides, clinical trials are afflicted by numerous issues such as high cost, lack of diversity in trial participants, and the exclusion of relevant subjects because of geography. The advent of virtual clinical trials has largely minimized these inadequacies.
The current scenario requires patients to quarantine themselves at home, making it difficult for doctors and researchers to reach out and collect data. During these times, “at home” clinical trials prove to be a logical alternative since it eliminates the need to visit hospitals or research institutes.
Curebase is a decentralized CRO that provides software platforms to study patients at home through services like telemedicine, mobile phlebotomy, electronic health record, and smart device integration. With its newly launched online platform CURE-19, it aims to track the status of COVID-19 patients and collect their data to generate a novel, in-depth dataset with real-world context.
With the CURE-19 platform, patients anywhere in the U.S. can contribute from the comfort of their homes and help researchers understand the disease better. By employing virtual doctors, in house sample collection, and direct to patient supplies, the trial will be fully conducted in a virtual format.
With the help of its partners, Curebase would further strengthen the patient dataset with the integration of genomics, proteomics, metabolomics, and microbiome data. This is a non-profit initiative that runs with generous support from world-class cloud software products like Human API, 1upHealth, and DrugBank.
Curebase complies with 21 C.F.R. Part 11 code and Health Insurance Portability and Accountability Act of 1996 (HIPAA), and offers features like standardized drug coding, auditability and informed consent practices compliant with good clinical practice (GCP), setting it apart from many other direct to patient data collection companies.
Multiple Tests, Free of Cost
To generate a comprehensive COVID-19 patient dataset, Curebase has collaborated with three leading diagnostics startups and a leading digital therapeutic startup that will run diagnostic tests for free.
- Sano Genetics, a precision medicine company, will run free genetic tests for COVID-19 patients,
- Persephone Biosciences will sponsor the search of the gut microbiome for identifying COVID-19 biomarkers in the stool samples of patients,
- DiscernDx will run proteomics and metabolomics analysis from the blood samples, and
- Closed Loop Medicine will monitor the blood pressure of patients and healthy individuals through their app while giving small incentives like gift cards to participants.
Data Safety and Availability
The data from these studies will be stripped of any personal information (deidentified), keeping the identity of the patient safe. All data generated by the platform will be made available as an open-source for researchers who would like to analyze and extract meaningful information for the benefit of public health. Researchers can also use this platform to run at-home trials of COVID-19 patients at no cost on the condition that the emergent data is freely accessible.
Participating in the CURE-19 platform is quite simple. Any adult patient, sick or healthy, can join the program by connecting their health records and smart devices with the platform. Patients will be required to monitor their symptoms once a week and complete medical questionnaires on the platform. Physicians and hospitals can also get involved by referring their patients to the platform’s website https://www.cure19.org/.
Speaking exclusively to GeneOnline, Chief Executive Officer, Tom Lemberg said, “Curebase has been running decentralized clinical trials for years, but the need has never been greater than during COVID-19. With the CURE-19 platform, any U.S. patient can enroll into clinical studies right at home and help drive scientific discoveries”.
Editor: Rajaneesh K. Gopinath, Ph.D.
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