A discussion document forming part of the 21st Century Cures initiative has been released compiling discussions and ideas from both Democrats and Republicans as to how to approach the future of the drug development process.
The paper produced by the House Energy and Commerce Committee is embedded below, and includes a proposal to reduce administrative delays in the clinical trial process by removing the “antiquated framework” set up before trials involved multiple investigators across a number of different trial sites, including the need for each proposed trial to have an institutional review board (IRB) approval before patient recruitment even begins.
Furthermore, the proposed Clinical Research Modernization Act discussed in the guidance would “stipulate that clinical trials subject to FDA regulations should not also be subject to the duplicative—and sometimes conflicting—provisions known as the Common Rule under the Public Health Service Act.”
The paper, unveiled by Committee Chairman and US Representative Fred Upton, was applauded by Doug Peddicord, Executive Director of the Association of Clinical Research Organizations (ACRO) who said the document “provides the outline for a solid framework” to improve the clinical trial process for the benefit of patients.
“We are particularly encouraged by draft proposals to enhance data sharing and make greater use of real world evidence, streamline the review process for clinical trials, and make clinicaltrials.gov a more useable tool for patients, physicians and researchers.”
The guidance also includes draft provisions to incorporate patient perspectives into the regulatory process, modernize medical product regulation, build on the 21st Century Medicine foundation, and support continued innovation in R&D.
It was also commended by industry group the Biotechnology Industry Organization (BIO) which contributed to the discussions which formed the document.
“Working with member companies, patient advocacy groups, and other stakeholders, we developed numerous proposals to create a public policy environment that encourages the use of 21st century scientific tools, advancements in molecular biology, and novel bioinformatics to continuously develop and improve upon therapies that can prevent, diagnose and treat all stages of disease,” said CEO Jim Greenwood.
“We are pleased to see several of our priority suggestions in the discussion draft, including the need for a large-scale national research commitment to study precursors and signs of disease and disease risk factors for chronic conditions.”