Written by Mohana Navare on Wednesday 17th November 2021
In collaboration with F. Hoffmann-La Roche global medical affairs, eClinicalHealth has partnered with OPEN Health and Optimum Patient Care (OPC) to deliver METNA RA, a cross-sectional electronic survey to validate a new methotrexate treatment adherence tool in rheumatoid arthritis (RA).
Pharmaceutical companies are increasingly conducting direct-to-patient clinical studies to generate endpoint data to help prove the efficacy of investigative medical products or procedures. To achieve this, many are developing electronic patient-reported outcomes (ePRO) tools to measure, for instance, a patient’s subjective quality of life or self-assessed disease severity. However, for these endpoints to be accepted by regulators, clinicians, and researchers as having scientific value, ePROs must first be validated to prove they measure their intended outcomes accurately.
Validation studies can be difficult to undertake. The most effective direct-to-patient studies depend on high-quality data, ethical access to patient cohorts, trusted collaboration between stakeholders, and efficient communication to knit everything together. A great example is METNA RA, a psychometric validation study led by Roche global medical affairs in RA. The multicentre study was conducted in collaboration with the clinical trial technology provider eClinicalHealth, as well as with OPEN Health. eClinical Health specializes in the analysis of real-world data and partners with healthcare providers across primary and secondary care; OPC provides quality improvement programmes and real-world/pragmatic research in primary care.
To initiate METN RA, eClinicalHealth partnered with OPEN Health to determine the feasibility of the study, develop the study design and protocol, and establish an infrastructure for implementation. Critical requirements included finding a primary care database (OPCRD) to map the patient population, and a delivery partner (OPC) to recruit and support “high-density” practices (i.e., those with the highest numbers of eligible patients) to field the study. OPEN Health’s experience in working with real-world data, along with its reach into the primary and secondary care ecosystem, proved crucial in identifying the datasets that would be best suited to METNA RA. It also conducted the initial PDC calculation to provide a baseline measure for the study and inform the potential stratification in the population at large, in turn informing recruitment planning.
“The results are, first and foremost, a testament to the collaboration between our expert partners,” says Karl Landert, CEO, eClinicalHealth. “OPEN Health provided invaluable insight that helped shape the feasibility study and protocol design, and they were the conduit to the primary and secondary care data and relationships that drove the study. OPC’s access to and trusted relationships with primary care providers and its support model with research coordinators were instrumental in the study’s success. Alongside it, Clinpal (eClinicalHealth’s end-to-end clinical research platform) provided a digital engine that helped connect stakeholders, automate processes, manage workflow efficiently, and collect study data. As METNA RA shows, end-to-end platforms can transform processes and bring operational efficiencies to complex direct-to-patient studies. When combined with specialist partners working in true collaboration, the potential to improve outcomes is significant.”
OPEN Health brings together deep scientific knowledge, global understanding, and broad specialist expertise to support our clients in improving health outcomes and patient well-being. We are united as one flexible organization, harnessing the power of the collective to solve complex challenges. Our global team of experts—many with PhD or PharmD degrees—work strategically alongside our client partners in Medical Affairs, HEOR, Market Access, and Commercial teams across a wide range of therapy areas.
In 2017, Roche wanted to validate a PRO tool it had developed to assess medication adherence in RA patients being treated with methotrexate (MTX). The tool, the MTX Experience Questionnaire (MEQ), aimed to help doctors better understand patients’ experiences and identify common drivers of non-adherence. The goal was to give clinicians an instrument that would not only allow them to monitor adherence in routine clinical care but also help them to detect and manage patients with poor adherence to their MTX treatment. METNA RA was a multicenter, cross-sectional, electronic survey to validate the MEQ.