Mapi - The Breadth and Depth of our Services
Mapi is the leading Patient-Centered Research company serving academia, life science researchers, and the pharmaceutical industry for over 40 years. Mapi’s commitment to patient-focused research is demonstrated not only by our expertise and nearly four decades of service but also through our direct contribution back to the industry. Mapi is among only a handful of global organizations that is capable of engaging with a patients’ complete ecosystem, their HCPs, Patient Communities, payers, and even regulators. And only Mapi has the unique history to make us the most experienced at interacting with all of them.
Mapi was founded in 1974 and was focused on the patient from the very beginning. With our Real-World Evidence and post-approval research services, consulting expertise, and publications to our not-for-profit entity, Mapi has been the leading industry driver toward patient-centered research for nearly four decades.
Mapi has donated and re-invested millions of euro to improve life science research and development, as well as establish the patient as the center of clinical research. These investments include: intellectual property services; funding to establish industry working groups with regulatory bodies, including the ERIQA project and the PRO Harmonization initiative; subsidizing academic researchers and founding the Mapi Research Trust, a non-profit center for curating Clinical Outcome Assessments.
During our decades of Patient-Centered Research history, we’ve seen an industry eager to embrace patient insight. From the mid-1970s to the early 1980s, the promise of faster and cheaper research forced many companies to only invest in the data needed to satisfy safety and efficacy, leaving patient insight for post-approval research as an afterthought to drug approval. Unfortunately many companies still have this view today.
We have also seen non-governmental agencies such as health technology assessers, accountable care organizations, patient advocacy groups, key opinion leaders, and even healthcare payers rely on the foundations Mapi helped establish.
These foundations include: the establishment of the concepts and methodology behind Linguistic Validation, leading to Mapi completing over 35,000 international versions of 2,300 instruments; Mapi’s leadership in support of Post-Approval Epidemiology and REMS/RMP programs; and the Pro-Harmonization initiative, which allowed us to proactively affect the regulatory environment.
In the 90s, clinical research began adopting these new assessment tools and methodologies. However, the challenges of applying these tools in a cross-cultural multi-language world demanded a new way to gather patient insight. John Ware, together with the Mapi Institute, helped define the elements of Linguistic Validation, and one of the first instruments designed for collecting patients’ Quality of Life on a global clinical trial was the new linguistically Validated SF-36. However, the increasing cost of clinical development kept the focus on expediting regulatory approval, and placed the emphasis of research on the bio-markers and bio-chemistry as the primary endpoints in most research.
The exploding volumes of clinical research and academic work in Patient-Centered Research in the late 1990s and early 2000’s increased both the demand for Linguistic Validation and support of Health Economics, an academic science that had become an essential aspect of the clinical research world. Mapi helped by establishing the ERIQA group—made up of industry experts, health authorities and academics—to develop foundational guidelines on HRQL evaluation in drug development.
At the initiative of the ERIQA group, Mapi also helped launch the PRO Harmonization Group, which brought together the members of ERIQA, ISOQOL, ISPOR, the ‘Health Outcomes Committee’ of PhRMA, and the FDA to harmonize the guidelines on the use of PRO tools in clinical studies. This resulted in the creation of the PRO Guidance document finalized by the FDA in 2009.
In the interest of accelerating the continued adoption of Patient-Centered Research, Mapi established the Mapi Research Trust in 2004. This is a non-profit organization facilitating access to information in the fields of Patient-Centered Outcomes and encouraging exchanges between academics, pharmaceutical companies, and international organizations around the world. Funded almost exclusively by Mapi, the Mapi Research Trust has taken on the burden of curating thousands of Patient-Centered Outcome instruments, their Linguistic Validations, and Research Publications.
The Mapi Research Trust supports research efforts by annually responding to over 5000 licensing support requests and over 30,000 online informational searches. Thousands of academics, students, private institutional researchers, clinical research organizations, translation companies, and pharmaceutical companies utilize the Mapi Research Trust in their quest to develop solutions to collect patient insight.