Transmineo has joined forces with Wavy Health to build the MyOwnData platform and its mobile app to:
make studies more inclusive and representative from low-treshold to participation and easy accessibility to trials for study participants (patients).
collect RWE for the purpose of health technology assessments (HTA) of orphan drugs in an efficient, trustworthy & scientifically robust way.
We have designed an innovative platform that can collect RWE while the patients remain in control, so they can decide themselves what data is contributed, who has access to it and for what purpose access is given, and they can also be rewarded for their contribution. A study sponsor (i.e. pharmaceutical company) will only have access to the results of the analyses (RWE) that they have to submit to the HTA agencies and not to the (privacy-sensitive) data entered by patients.
Questionnaire fatigue, use of device-unfriendly electronic questionnaires, physical and mental limitations due to the disease and the lack of feedback & reward are frequently cited issues that patients mention as reasons for dropping out of studies.
We apply gamification in setting up questionnaires and provide connections with wearables. Patients remain in control and manage their own data, linked to a reward system, via their own wallet.
Our solution (a SaaS/TaaS platform) is a new application of existing and proven technologies. Being able to present RWE is vital for the biopharmaceutical industry and it is becoming an integral part of the life-cycle management of their products, especially orphan drugs.
Not only the representativeness of the collected data, but also the representativeness of the included study population determines the reliability of the results. RWE for the purpose of HTA has to be retrieved from patients in a treatment setting. However, distrust in pharmaceutical companies creates a resistance from stakeholders to give manufacturers access to patient data. This has been demonstrated by the refusal to participate in certain subcategories of trials, which is associated with a specific patient profile. This may potentially cause recruitment bias that may explain the under-representation of certain categories of patients such as women or ethnic minorities in drug trials. But if companies fail to deliver RWE to support the real-life effectiveness of their drugs, it may also negatively impact access to these therapies for these same patients.
There is a need among both the patient and the manufacturer for a solution that guarantees the privacy of the patients and the quality of the RWE. The MyOwnData platform will not only give patients control over the use of their data, but it will provide an optimal user-experience tailored to specific patient categories to create strong study retention from study participants. That’s why we work with patients to design each app tailored to their functional capacities.
Our first pilot will include the setup of the MyOwnData platform to gather insights on the disease burden of patients with sickle cell disease living in the Netherlands.