Out-Law News 1 min. read
28 Aug 2015, 11:59 am
The topics for research have still to be finalised, but the Innovative Medicines Initiative (IMI) has indicated that it wants to collect "real world evidence" of data use in identifying and treating Alzheimer's.
"Recent advances in biomarkers and genetics now allow identification and potentially treatment of at-risk individuals in very early stages," the IMI's indicative proposal said. "Technological advances in electronic data offer the opportunity to develop real world data sets to facilitate decisions that improve care. Significant investments are ongoing to accelerate drug development from the perspective of biomarkers, randomized clinical trial (RCT) design, and RCT endpoints. However, relatively little has been done to facilitate the collection and analysis of high quality real world evidence (RWE)."
"The Real World Outcomes Across the AD Spectrum (ROADS) initiative proposes to develop and enhance public-private collaborative research programs to generate ‘AD-relevant’ health and social care data insights and to optimise databases for appropriate AD care and prevention for use in both pre- and post-launch research efforts," it said.
The IMI is a public-private partnership which will see up to €3.3 billion of funds committed to furthering research in the life sciences sector by 2024. Half the budget comes from EU public funding and the majority of the rest will be funded by companies that are members of the European Federation for Pharmaceutical Industries and Associations (EFPIA).
A final decision on what IMI projects will be proposed will not be made until "early autumn" but the IMI said that it could take forward a program of research aimed at developing "an outcomes-focused platform to empower policy makers and clinicians to optimise care for patients with hematologic malignancies", such as Hodgkin's disease.
One of the objectives of the proposed hematologic malignancies (HM) project would be to pool information from large and "diverse data sets" and design standards that would allow the data to be used by both health care providers and patients.
A 'coordination and support action (CSA) for the big data for better outcomes programme' has also been outlined.
"The big data for better outcomes programme aims to provide a body of evidence that may inform decision making by the relevant bodies and invest in enablers to transform healthcare systems towards a greater focus on healthcare value and increased outcomes," the IMI said in the draft CSA. "This change would be health care system transformation, encompassing payments, considering value, and supporting aligned incentives between primary and secondary care towards the same common goal of superior healthcare delivery, transparent data made available, etc."
