Richard L. Schilsky, MD, FACP, FASCT, FASCO, CMO & Executive VP, American Society of Clinical Oncology:
“Clinical trials of new cancer treatments were upended during the early months of the pandemic, causing widespread interruptions in trial enrollment, preventing some patients from receiving promising new treatments. People with cancer are especially vulnerable to coronavirus infection, so cancer research had to change virtually overnight to reduce the chances of patient exposure. Yet trials shutting down entirely or patients being forced off studies was averted in many cases because research sponsors and regulators acted quickly to create more flexible research practices.”

To hear more about the widespread effects of COVID-19 on Precision Medicine, Jan 25-27, 2021, sign up for the Free PMWC virtual conference (Powered by Zoom).

As COVID-19 spread across the US at the beginning of 2020, clinical care was disrupted at many levels including cancer clinics temporarily shutting their door. This forced patients to forgo treatment and large numbers of clinical trials were on the verge of coming to a halt. In fact, over 1,000 medical organizations reported clinical trial disruptions with an 80% decrease in new patients enrolling in trials. Many cancer centers reported that they couldn’t follow trial protocol. An ASCO survey launched in March 2020 identified some key findings including:

• How COVID-19 had an immediate impact on conducting clinical trials, such as halting screening and/or enrollment for non-therapeutic trials and curtailing the launch of any new clinical trials
• How COVID-19 created the greatest challenges for conducting clinical trials by decreasing patient ability/willingness to come to a site or enroll in a trial, limiting availability of ancillary services (e.g., radiology, surgery, cardiology) and by a reduction of staff, supplies, and laboratories
• COVID-19 resulted in various institutional policy changes including halting, limiting, and/or prioritizing screening and enrollment of ongoing and new clinical trials.

 As a result, ASCO carefully evaluated adaptations in care delivery and research operations. Their goal was to improve patient access to high-quality cancer care and opportunities for participation in research, as well as to ensure the ongoing well-being of patients with cancer, caregivers, and the oncology workforce. The newly modified pre-pandemic policies and practices recommendations were recently presented and with that, the goals for Cancer Clinical Research and Cancer Care Delivery.

The goals for Cancer Clinical Research include:
– Ensure that clinical research is accessible, affordable, and equitable for patients and therefore become more patient-centric.
– The cancer community should evaluate the impact of changes made to studiesduring COVID-19 that includes dimensions such as diversity of patients participating in trials; financial impact on patients and stakeholders; and patient safety, integrity, and interpretability of data.
– Design more pragmatic and efficient clinical trials that are better integrated into routine clinical care.
– Simplify, streamline, and standardize protocol requirements and research operations to minimize administrative and regulatory burdens on research sites.
– The cancer research community should develop consensus on documentation requirements for site selection, study implementation, data collection, protocol amendments and deviations, and adverse events.
– Recruit, retain, and support a well-trained clinical research workforce that is committed to providing patients with access to high-quality research.
– Promote appropriate oversight and review of clinical research conduct and results.

While the goals for Cancer Care Delivery include:
– Promote and protect equitable access to high-quality cancer care.
– Support safe delivery of high-quality cancer care.
– Advance policies to ensure oncology providers have sufficient resources to provide high-quality patient care.
– Recognize and address threats to clinician, provider, and patient well-being.
– Improve patient access to high-quality cancer care via telemedicine.

Now that restrictions have been modified or even eased in some places, some clinical studies are resuming, albeit in a different form. Many clinical changes we are observing and that have been implemented as a response to the COVID-19 pandemic may in fact be here to stay. These include:
– Modernizing clinical trial approaches by incorporating telemedicine/digital technologies, remote monitoring, and analyzing data using artificial intelligence.
– Delivering study drugs directly to patients.
– Decentralizing clinical trials by identifying where technology and other novel solutions can enable sponsors and CROs to take a hybrid approach to clinical trial design.
– Sponsors working to optimize/innovate study protocols.
– Study design that incorporates adaptive and agile master protocol infrastructures.

It is important to note that all the future changes impacting clinical trials must also improve healthcare and make access to quality care more equitable than it currently is. It is therefore important for the community to come together to debate future approaches that will change trial design and trial execution leading to reduced costs and better outcomes for all stakeholders, including drug developers, CROs, clinicians, and of course, the patients.

Richard L. Schilsky:
“The emergency policies put in place during the pandemic exemplify changes that could make cancer clinical trials more efficient, flexible, and accessible to patients in the future. I look forward to examining this issue in greater detail with colleagues during the 2021 PMWC conference.”

The PMWC 2021 COVID Program – January 25-27, 2021 – is designed to focus on the past and future clinical impacts of COVID-19 with the following sessions:
Fireside Chat with Dr. Fauci

• Speakers: Anthony S Fauci (US National Institute of Allergy and Infectious Disease NIAID) and Lee Hood (Providence Health)

The Million Person Genome/Phenome Project and Disruptive Insights from a COVID 19 Clinical Trial – Keynote by Lee Hood (Providence Health)

How COVID-19 Changed Clinical Trial Dynamics and Environment – Session chair: Patrice Hugo (Q² Solutions)

• Speakers: Jia Xin Annie Yu (CRI) and Kristina McGuire (Regeneron Pharmaceuticals)

The Impact of COVID-19 on Cancer Care and Future Implications – Session chair: Helmy Eltoukhy (Guardant Health)

• Speakers: Laura Esserman (UCSF), Laurie H. Glimcher (Dana Farber), Mark Fleury (ACS CAN) and Pelin Cinar (UCSF)

Clinical Trials in the Era of COVID-19 (ASCO’s TASK FORCE RECOMMENDATIONS) – Session chair: Richard Schilsky (ASCO)

• Panelist: Jane Perlmutter (Gemini Group), Fareed Melhem (Medidata Solutions), Nathan Pennell (Cleveland Clinic), and Marty Tenenbaum (Cancer Commons)

The Regulatory/FDA Perspective – Session chair: Sheila Walcoff (Goldburg Strategies LLC)

• Panelist: Janet Woodcock (FDA) and Ruth March (AstraZeneca)

 Building a Health Data Platform that Supports COVID-19 Health Care – Session chair: Joel Dudley (Tempus)

• Panelist: Anne Wyllie (Yale), Carlos Bustamante (Stanford), James Heath (Institute for Systems Biology), and Christopher Mason (Weill Cornell Medicine)

Health Disparities in the COVID-19 Pandemic – Session chair: Kirsten Bibbins-Domingo (UCSF)

• Panelist: Diane Havlir (UCSF), Susana Rojas (Calle 24 Latino Cultural District), and Kristen Azar (Sutter Health SHIQHES)

Forging New Connections for a Sustainable Testing Ecosystem – Session chair: Steve Kulisch (Fluidigm)

• Panelist: Charles Chiu (UCSF), Sree Chaguturu (CVS), Mara Aspinall (ASU) and Eric Van Gioson (DARPA)

 Tackling the Mental Health Crisis in the Wake of COVID-19 Session chair: Amir Dan Rubin (One Medical)

• Panelist: Elissa Epel (UCSF)

Be part of this important discussion and join us for this free, virtual PMWC 2021 COVID conference (Program), taking place virtually January 25-27, 2021. The event is Powered by Zoom.

Register now!
Sincerely,

Tal Behar
President, PMWC – The Precision Medicine World Conference