Accelerating the Pace of Oncology Clinical Trials in the Wake of COVID-19

he COVID-19 pandemic has harmed thousands of cancer patients by delaying or postponing clinical trials for new anticancer agents in various indications. Norman Sharpless, director of the US National Cancer Institute, projects an increase of 10,000 breast and colorectal cancer deaths during the coming decade as a result.

The impact of 2020 trial delays could have a significant downstream effect on the treatment of cancer patients for years to come; even a 20% slowdown in enrollment across trials could lead to two or three new oncology drug approvals getting delayed. However, it is possible there is a silver lining as COVID-19 has also forced significant workflow and regulatory changes. These new technologies and data enable a “virtual” or decentralized clinical trial (DCT) model. This alternative model is the key for research continuity and could revolutionize clinical operations and (finally) put patients first.

Patient-Centric, DCT Model

• ePRO/eConsent/eCOA: There are many electronic tools available for enrolling patients in trials, confirming consent, and collecting patient-reported (PROs) and clinician-reported outcomes (COAs, Clinical Outcome Assessments). These tools minimize the need for patients to travel, physically interact with staff, and complete paperwork.
• Telemedicine: Telemedicine platforms allow clinicians to virtually monitor adverse events and advise patients, reducing in-person visits. The frequency of video visits helps to keep patients engaged, which means fewer patients dropping out of trials and earlier study completion so new therapies reach patients faster.
• Synthetic trial control arms: Data in electronic health records from routine care, medical insurance and pharmacy claims, lab results, and other sources (referred to as real world data, or RWD) may be evaluated to supplement or replace data collected through traditional trials. Comparing treatment decisions and outcomes with RWD can often replace a study control arm. It can also generate real world evidence (RWE) to support an additional indication for an approved drug.
• Self-administered formulations: To enable more virtual trials and reduce patient burden, a greater emphasis should be made on developing therapies that can be administered by patients at home, such as self-administered injections, patches, and oral products. Telemedicine coupled with shipping medications could enable this transformation.

In an interview for this article, cancer survivor and patient advocate Joan Venticinque noted, “In response to COVID-19, numerous government, academic, and industry groups have realized they need to work to limit disruptions to clinical trials by allowing more flexibility. With virtual visits, eConsents, wearable technology, direct shipping of drugs along with routine monitoring, patients can have access like never before. This DCT model is something patients have been asking for, and it is long overdue.”

Overcoming DCT Innovation Hurdles

Fortunately, there is now regulatory support and traction across technology players. Some are working to develop end-to-end virtual solutions, and many contract research organizations are working with advanced DCT platforms to speed the rate of innovation and improve the patient experience.

This digitization of clinical trial data and processes should make it easier to use RWD as part of drug development. RWD can inform trial design, eligibility, and synthetic trials, and provide new insights on the patient journey. But RWD can also be complex due to its fragmented nature, and ensuring patient consent and protecting patient privacy with data aggregation can be difficult and complicated.

The good news is that RWD has enormous potential. It exists in large quantities and the FDA has already implemented new supportive efforts designed to evaluate the use of RWD for RWE. In addition, researchers have already proven that RWD can be used to test new treatments. The 21st Century Cures Act also encourages the use of RWD to generate RWE for regulatory decision-making. As the FDA has repeatedly emphasized, the key is to ensure that researchers have access to data that is fit-for-purpose.

Collaborations Could Reverse the Impact on Cancer

The pandemic has already shown that swift industry collaboration can improve patient outcomes. The American COVID-19 Collaborative Enabling Seamless Science (ACCESS), for instance, formed to quickly deploy DCT technology for monitoring, testing, and developing diagnostics and treatments. The ACCESS vision aims to 1) provide data for mitigation efforts, 2) provide RWD to accelerate effectiveness of evidence generation on new treatments and vaccines, 3) enable immediate screening and enrollment of participants for treatment and vaccine clinical trials, and 4) create a dynamic system with modern technology to protect Americans’ health and national security.

Collaborative approaches, such as ACCESS and the COVID-19 Research Database (a pro-bono consortium to make RWD available for COVID-19 related public health research), provide the infrastructure for more accessible clinical trials and for accelerating the use of RWD for research and drug development. These types of novel approaches are critical to shortening timelines without adding clinical burdens to patients, researchers, or clinicians.

The technology to “go virtual” is available today. Industry and researchers can leverage DCT technology and RWD at scale. The pharmaceutical, healthcare technology, and advocacy communities are poised to make that happen. If all stakeholders across the industry commit to these efforts, it’s possible to rapidly change the future of clinical development and re-write the story for cancer patients.