The Department of Clinical Pharmacy and Pharmacology of the UMCG has received two large EU grants for two studies.
One study (called PRIME-CKD), led by prof. dr. Hiddo Lambers Heerspink, concerns a large international study in the field of personalized medicine in the treatment of chronic kidney injury. The total budget of the study is 9.6 million euros, of which more than 3 million will go to the UMCG. The other study (MORE-EUROPE) is led by prof. dr. Peter Mol and focuses on the more effective and ethical use of registry data to support patient-centered decisions. The budget for this research is €6.9 million, of which €1 million is earmarked for the UMCG.
Both research projects align very well with the UMCG spearheads around better use of medicines and personalized medicine. Both grants were awarded from the EU Horizon program, the main EU fund for research and innovation.
The specific objectives of the PRIME-CKD research are:
a. Validate and record recently discovered signaling substances in blood and urine that can predict how a patient with chronic kidney injury will respond to therapy.
b. To give physicians and patients guidance on how these signaling substances can best be used in practice. This will include the social sciences and health technology aspects of individualized treatment of chronic kidney disease.
c. Developing methods and procedures that can be used by researchers, pharmaceutical industry and regulatory authorities to further implement the potential of 'companion diagnostics' [=medical tool that provides information on the effective and safe use of a drug belonging to that diagnostic] in health care.
The EU speaks of very relevant and clear objectives and praises the design, methodology and interdisciplinarity of the study. The research involves the collaboration of 16 institutions from eight countries.
The main objectives of the MORE-EUROPE research led by Peter Mol are:
a. to expand the knowledge of drug efficacy and safety using 'Real World Data' (RWD; data obtained from Clinical Practice) and to supplement data from clinical trials (so-called RCTs = randomized clinical trials: randomized controlled trials) using specific 'case' studies supported by developed new analytical tools and by establishing a protocol for a registry-based RCT;
b. develop a methodological framework including analytical tools to integrate evidence derived from RCTs and (multiple) RWD sources;
c. develop an ethical framework describing practice-based ethical requirements for generating and using patient-relevant RWD to support decision making;
d. create an integrated framework, incorporating methodological tools and ethical considerations, to promote the acceptance and use of evidence based on RWD (=RWE, Real World Evidence) throughout the drug life cycle in drug registration and HTA guidelines and decision-making;
The EU praises the transferability of the models and frameworks to other conditions and treatments, the involvement of key stakeholders, and the wide range of both expertise involved in the research.
The budget is 6.9 million, of which 1 million is earmarked for the UMCG. The project involves 14 both public and private organizations.
