What Do Physicians Need to Understand and Use the Expanded Access Process for Their Patients?
First large-scale study underway to learn from physicians what they need to apply to use experimental medicines for their patients
Seeking Physician Input on Using Expanded Access
To Experimental Drugs for Their Patients
Clinical Research Pathways Needs Assessment Survey
Aims to Assist Physicians
Newswise — ATLANTA, June 26, 2018—Clinical Research Pathways has launched an effort to learn what information and other resources physicians need to seek access to experimental drugs for desperately ill or terminal patients, using the expanded access program.
Under the U.S. Food and Drug Administration's expanded access process, physicians can work with pharmaceutical companies, FDA and institutional review boards to apply for experimental drugs or devices when all treatment options for patients have been exhausted.
"This is one of the first large-scale efforts to explore what physicians need to take advantage of this program for their patients," said Marjorie A. Speers, Ph.D., executive director of Clinical Research Pathways. "Confusion or a simple lack of knowledge can lead to delays in obtaining an investigational drug just when a patient needs it most. This needs assessment survey can help us learn what knowledge gaps exist and enable us to design and promote programs to fill those gaps.
"Although some laws related to the process have changed recently, the core elements of this process remain: There is a pathway to obtaining these drugs, and our goal is to make it easier for physicians who choose to treat their patients this way navigate the process."
The needs assessment survey, conducted by Virginia-based McKing Consulting Corporation for Clinical Research Pathways, is now underway. Physicians who wish to participate can visit this site. Information will be gathered over the next four weeks. It is supported, in part, by GSK, (GlaxoSmithKline), Johnson & Johnson and Pfizer Inc.
Although all physicians can participate if they choose, the effort intends to gather the majority of responses from oncology, neurology and infectious disease specialists. McKing and Clinical Research Pathways have begun reaching out to physicians to invite participation.
About Clinical Research Pathways: Clinical Research Pathways works to improve health and well-being for all by creating pathways to new medicines. The 501(c)(3) organization develops programs that increase diversity in research and expand access to experimental drugs. By opening access and advancing treatments, Clinical Research Pathways helps make new, effective medicines available to the public. For more information, go to www.clinicalresearchpathways.org. To sign up to receive news, click here.