Skip to content

Pink Sheet – US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data

Pink Sheet – US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data

Executive Summary

Oncology Center of Excellence program will use the Evidence Accelerator to examine COVID’s impact on treatment initiation, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.

The US Food & Drug Administration’s COVID-19 Evidence Accelerator is evaluating the effects of COVID-19 infection on cancer patients via a new Oncology Center of Excellence initiative dubbed “Project Post COVIDity.”

The initial focus will be on understanding how COVID infection impacts cancer patients “on active treatment and associated immunotherapy,” the Oncology Center of Excellence describes in its 2020 annual report issued earlier this month.

OCE hopes the project will enable “longitudinal understanding of the impact of COVID on patients with cancer post infection, including the impact of infection on treatment initiation or delays, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.”

Project COVIDity was launched in direct response to the pandemic, but the initiative will also accelerate an ongoing effort to develop and expand the use of real-world evidence in regulatory activities. 

FDA describes Project Post COVIDity as “a regulatory research opportunity” to conduct real-world data studies and “develop RWD parallel analyses” by using the Evidence Accelerator “to answer specific scientific questions that can provide beneficial knowledge for clinicians and patients” in areas such as trial eligibility criteria, real-world practice patterns, and drug safety.

The Evidence Accelerator, led by the Reagan-Udall Foundation and Friends of Cancer Research, was designed to gather high-quality real-world evidence during the pandemic, focused on three primary “work streams”: therapeutics, diagnostics, and vaccines. It has expanded in scope since its inception in April 2020 as it saw broad interest from stakeholders.  (Also see “US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines” – Pink Sheet, 11 Jun, 2020.)

While continuing prior efforts like Real Time Oncology Review and Project Orbis, OCE launched eight new initiatives during the year.

OCE’s annual report updates its expanding list of initiatives – most of which are named “Projects” by OCE Director Richard Pazdur – even as the center oversaw an extraordinary number of approvals amid the COVID outbreak.

The headline of Pazdur’s cover letter to the annual report succinctly captures OCE’s rallying cry during 2020: “We have not forgotten patients with cancer during the COVID-19 pandemic.” That was a clear message from Pazdur during a podcast interview with Pink Sheet early in the pandemic.  (Also see “US FDA’s Oncology Center In The Lockdown: ‘Business As Usual’” – Pink Sheet, 18 Jun, 2020.)

The output in oncology approvals in 2020 was truly extraordinary, with 19 novel drugs and biologics (18 counted among the 53 total NME approvals by CDER, plus a new CAR-T therapy approved by CBER). Most of those approvals came well ahead of the priority review deadline set by the user fee agreement. (Also see “Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune” – Pink Sheet, 18 Jan, 2021.)

In addition to maintaining an incredibly efficient review pace, OCE highlights the work by the division to contribute to guidances issued in response to the pandemic to support rapid adaptation in clinical trials and requests for Expanded Access.

“Several approvals were aimed at reducing the interaction of patients with the health care provider to limit potential COVID-19 exposure,” OCE notes. “These included subcutaneous dosing formulations, longer dosing intervals, and oral formulations of already approved drugs.”

OCE also continued its efforts to innovate its own processes with diverse “Projects” to tackle new goals. While continuing prior efforts like Real Time Oncology Review and Project Orbis, the group launched eight new initiatives during the year.

One recent initiative, “Project Livin’ Label,” provides CME credit for clinicians who agree to read a newly approved product label and watch a webinar discussing the development history of the product.  (Also see “Pazdur Unplugged: US FDA’s “Project Livin’ Label” Shows Back Story On Cancer Drug Approvals” – Pink Sheet, 15 Feb, 2021.)

Another is “Project Tracking,” which will help OCE track the ever-expanding project list. (See table at end of story for a list of projects.)

‘Projects’ To Expand Trial Enrollment

Among the other OCE initiatives launched in 2020 are two projects focused on increasing the enrollment of traditionally underrepresented populations in clinical trials: Project Equity, focusing on ethnic and gender minorities, and Project Silver, focusing on the “older adult” (over 75) population.

The Project Equity program has three primary objectives:

  1. Publish guidance on facilitating diversity in clinical trials,

  2. “Foster collaboration” between stakeholders “to promote more equitable and inclusive research and policy practice,” and

  3. Promote research that better characterizes “outcomes across historically underserved populations in medical research.”

In highlighting achievements for the program during its first year, the OCE annual report points to a workshop on examining the underrepresentation of African Americans in multiple myeloma trials and a symposium on understanding the barriers to trial participation for sexual and gender minorities.

Project Silver is a global regulatory effort to discuss key applications and development programs with indications heavily affecting over adults. OCE notes the first draft guidance on inclusion of older adults in cancer trials was published in 2020.

Both initiatives are meant to complement existing diversity and inclusion efforts at OCE, including Project Community, which works to increase minority participation in clinical trials and knowledge of genetic databases.…