The Critical Path Institute (C-Path), formed in 2005, is a nonprofit, independent (public/private) partnership. The Institute evolved from the FDA’s 2004 White Paper known as the Critical Path Report and was created under the patronage of the FDA’s Critical Path Initiative program.
The FDA’s report recommended the need for modernization through collaboration, which it likened to a choice between innovation versus stagnation. The FDA and C-Path signed a Memorandum of Understanding in 2005 to establish collaboration and promote shared interests through research, education, and outreach programs.
C-Path receives its funding from government agencies, including the FDA, grants from foundations such as the Bill & Melinda Gates Foundation, and fees paid by industry participants.
Where We Were
Biomedical research has advanced so rapidly in recent years that expectations about the pharmaceutical industry have grown exponentially. It seems, however, that the industry’s limitations have grown also.
The FDA’s report released alarming data. For example, the 250% increase in R&D was in sharp contrast to the 50% reduction in the submission of new products for FDA review. Its report highlighted the unacceptable failure rate of drugs being investigated in clinical trials.
FDA’s Opportunities List
A list of 76 projects, divided into six topic areas, was released by the FDA in March 2006 entitled the Critical Path Opportunities List. This publication analyzed the reason that drugs with the potential to cure diabetes, cancer, or Alzheimer’s disease are failing rather than becoming innovative medical products.
C-Path has made contributions to a substantial number of opportunities set forth by the FDA. Their total number of contributions is nineteen, covering five out of the six topic areas.
About COA
In March 2020, the FDA’s CDER funded an agreement to create a clinical outcome assessment consortium for rare diseases (COA). The first project for COA was to find measures that can assess how a child functions, feels, and survives each day against the impact of a rare disease.
The second project, which was run concurrently, is a review exploring how researchers respond to diversity (heterogeneity) in clinical trials and whether it is advantageous to personalize trial endpoints.
COA will eventually create a database that will be available to the public listing appropriate measures to be used in treatment trials for patients with rare diseases. The concept is that existing measures may be used or even modified when assessing diseases with common characteristics.
Looking Forward
The C-Path model has shown steady growth. Foundations, research institutes, and patient advocates are showing increasing interest in becoming part of the new consortia. Much of the interest can be attributed to C-Path’s previous or existing achievements.
