The Patient-Centered Outcomes Research Institute, or PCORI, announced last week that it will be granting a total of $12 million for up to 14 contracts for studies aimed at improving upon existing research methodologies to demonstrate clinical effectiveness.
The Patient-Centered Outcomes Research Institute, or PCORI, announced last week that it will be granting a total of $12 million for up to 14 contracts for studies aimed at improving upon existing research methodologies to demonstrate clinical effectiveness. The improvements seek to benefit researchers, policy-makers, clinicians, caregivers and patients in making tough healthcare decisions by offering more efficient processes and stronger validation benchmarks for research studies conducted in the public and private sector.
The news coincides with PCORI’s fifth priority initiative, “Accelerating Patient-Centered Methodological Research,” under its National Priorities for Research and Research Agenda, and is the first of many program funding announcements. In total, PCORI projects that $427 million in research commitments will be made to vendors by the end of 2013. Non- and for-profit organizations, hospitals, academic institutions, laboratories and units of local and state government are encouraged to apply for grants by the deadline of March 13, 2013.
Areas that applicants are asked to focus on include methods for conduct of systematic reviews of patient-centered comparative effectiveness research topics, identifying optimal methods for engaging patients in the research process, and methods to enhance the reproducibility, transparency, and replication of patient-centered outcome research, among others.
In addition, PCORI also announced today that its Board of Governors adopted 47 revised Methodology Standards intended to steer the administration of sponsored research. These revised standards resulted from over 124 sets of public comments over a 54 day discussion period. PCORI’s Methodology Committee also came up with 62 recommendations for researchers with regard to Standards for Formulating Research Questions. Particular areas included patient centeredness, dissemination, research prioritization, general and crosscutting methods for all patient-centered outcome research, and specific design approaches.
These new Methodology Standards suggest that government and industry are moving toward common ground on just how to measure the effectiveness of clinical interventions relying on drugs. The big question is how these standards and the funding that accompanies them will shape the future direction of research…and whether that research will begin to drive bottom-line decisions on access and reimbursement.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Cell and Gene Therapy Check-in 2024
January 18th 2024Fran Gregory, VP of Emerging Therapies, Cardinal Health discusses her career, how both CAR-T therapies and personalization have been gaining momentum and what kind of progress we expect to see from them, some of the biggest hurdles facing their section of the industry, the importance of patient advocacy and so much more.
ROI and Rare Disease: Retooling the ‘Gene’ Value Machine
November 14th 2024Framework proposes three strategies designed to address the unique challenges of personalized and genetic therapies for rare diseases—and increase the probability of economic success for a new wave of potential curative treatments for these conditions.
Tirzepatide Demonstrates Significant Benefits for Patients with Pre-Diabetes, Obesity Over 176 Weeks
November 14th 2024Results from the Phase III SURMOUNT-1 study show that tirzepatide, a dual GIP and GLP-1 receptor agonist, achieved substantial average weight loss of 22.9% in patients with pre-diabetes and obesity.