Plotting a course for ‘expanded access’ programs

With considerable White House hoopla, the National Right to Try law was passed in mid-2018, trailing in the wake of numerous state-level laws that had been passed with the same purpose in recent years: to streamline access to experimental medicines for sick patients, a last-chance hope for saving some lives. However, both before those laws were passed—and to this day—a broader effort has been underway under the general theme of “expanded access” (EA). And that effort, which has the potential to shake up current clinical trial practices, will be the theme of a January 27-29 meeting in Washington, the Expanded Access 3.0 Summit.

EA3 will bring an impressive set of speakers, including Janet Woodcock, director at CDER; Toni Fauci, director of the National Institute of Allergy and Infectious Disease at NIH; and numerous leading patient-advocacy groups, researchers and academics. “Expanded access is a larger concept than right-to-try laws,” says Jess Rabourn, executive director of EA3 and CEO of a company called Wide Trial, Inc.

Wide Trial, and organizations like it, are trying to facilitate the use of EA in conjunction with conventional clinical trials, first to give therapy access to groups of patients (not just individuals, as is the case with right-to-try) and secondarily to gather more—and potentially better—real-world data on therapies as they are being developed. Rabourn notes that the roots of EA go back to the late 1980s to accommodate people with AIDS when exploratory treatments were being developed. The practice remains widely mischaracterized, he says, and more can be done to improve inclusivity in the clinical development process and dissolve the barriers faced by manufacturers, health care providers, and patients.

EA3 will be held at the National Press Club, Washington, DC. More information is available at easummit.net.