Adapting oncology clinical research practices and therapeutic development strategies in the covid-19 era

The COVID-19 outbreak that began in Wuhan, China, in December 2019 was declared a pandemic on March 11, 2020 by the World Health Organization, and has since affected almost every country around the world. Cancer patients have been significantly impacted, through both clinical practice as well as engagement and participation in clinical research. This has had a significant impact on cancer care for patients and drug development timelines for sponsors; and as a result contract research organizations (CROs) had to quickly pivot and adapt their strategies to ensure patients stayed safe from COVID 19, while continuing to participate in trials. Since this pandemic is anticipated to continue for an unknown period of time, we need to carefully evaluate the lessons learned so far in the COVID-19 era, and determine how to leverage these experiences to positively impact oncology drug development in the future.

Understanding the impact of COVID-19 on clinical oncology and research

As of early September of this year over 26 million people have been diagnosed with the SARS-CoV-2 virus infection, and more than 900,000 have died. In addition to this direct morbidity and mortality, the pandemic has also negatively affected the ability to care for patients with other diseases due to the overloading of medical systems. In oncology, the pandemic has impacted both standard-of-care (SOC) treatment and clinical trials.

A primary goal in oncology is early diagnosis and treatment of a patient’s cancer. However, the COVID-19 pandemic has dramatically reduced patient willingness and ability to access medical care. In turn, this has reduced visits to general practitioners, subsequently reducing referrals for cancer screening and thus timely diagnoses. For patients who are able to get to an oncologist – those with existing cancer, or those who have been diagnosed during the pandemic – there is an inability of medical systems to offer them the same quality of care due to the massive repositioning of clinical resources for COVID-19.

Shortages of staffing and space due to COVID-19 also exacerbated the effect of reduced capacity for oncology related diagnostics and procedures, translating to delays in treatment. For example, radiation therapy, chemotherapy and immunotherapy can be difficult if not impossible to administer outside of the clinic, and surgical procedures are restricted due to the lack of capacity in the intensive care setting due to COVID 19 cases requiring this bed space. In the case of patients with existing disease, monitoring quality of life issues, disease progression or response to treatment can be challenging due to institutional limitations that impact the ability to provide remote care.

The difficulties that affect quality of care in the SOC context inevitably affect clinical trials, in ways both immediate and delayed. Protocol-mandated assessments become difficult or impossible to perform at a time when fewer patients are willing to come to hospitals for in-person visits. Broadly, delays in study-related data collection can impact the integrity of data response assessment criteria for efficacy and evaluation of safety of these clinical trials. COVID-related delays can even impact routine labs, increasing the likelihood of protocol deviations and decreasing the chance of identifying or preventing certain adverse events. Outside of difficulties in trial execution, many new trials are delaying their launches, preventing progress on the evaluation and delivery of promising treatments.

Exploring lessons learned for clinical oncology and research from COVID’s first wave

As some countries experience a lull and/or reduction in new cases following the first wave of COVID-19, many medical systems now have a moment to reflect on lessons learned and be better prepared for subsequent crises, such as a widely expected second wave of SARS-CoV-2 infections. At a high level, we have garnered a few insights that are applicable for oncology trials:

Embrace patient-centric solutions: Telemedicine has been widely promoted and adopted during the pandemic, but many medical systems need to continue to remove barriers to remote care. This includes improving patient and clinician access to resources like video visits, app-based patient reporting of outcomes or safety concerns, or remote labs/mobile phlebotomy. Implementation of these strategies would minimize future disruptions to SOC for current patients and prevent interruptions of data capture in clinical trials while reducing the burden on the patient of frequent visits to the hospital.
Create methods to prioritize trials and care: Strained resources can be addressed in a patient-centric manner, for example with clinical algorithms to clearly define the prioritization of different cancer treatments. These algorithms should be optimized for patient benefit and center around established probabilities of benefit or harm when considering delaying any SOC diagnostic or treatment strategy.
At an institutional level, trial priority should also be determined in a patient-centric fashion, so that a pause or shutdown and re-initiation of clinical trials isn’t difficult to predict, and can be effectively messaged.
Maximize flexibility in clinical trial design: To minimize future disruption of cancer clinical research, the design of clinical trials needs to be reevaluated to maximize flexibility of remote data capture. For example, the need for on-site visits can be minimized by making assessments compatible with remote monitoring, and decentralized care including home visits by nursing staff, use of community oncology centers for patient infusions, imaging, and minor surgical procedures. In addition, by streamlining and minimizing the required datasets, trials can become more approachable for patient participation, and more flexible when resources are strained.
Ensure ongoing collaboration: The urgency of the pandemic has been a catalyst to accelerating engagement from all contributors to oncology trials design and execution. Through collaboration with specialists across relevant disciplines from infectious disease through autoimmune disorders to immuno-oncology, the trial design expertise of the oncology community has also been leveraged to a greater effect. The resulting trials, such as the RECOVERY trial, have progressed at remarkable speed from concept to enrollment. The lessons learned here in terms of inter-specialty collaboration, platform-design, and regulatory expediency, should be considered when designing the next generation of clinical trials in oncology, continuing to focus on extending life expectancy and supporting quality of life for cancer patients in the many areas of unmet need.

The impact of COVID-19 on clinical oncology and research cannot be overstated. However, the drug development community can take away lessons that will help us focus more on the patient centric approaches to alleviate the burden of trial design and study execution as well as minimize the impact of any future disruptions. Ultimately, we hope to help improve the overall approach of clinical oncology and research by addressing some of the shortcomings exposed by the pandemic and cultivating a more robust and patient-centric system for cancer care.

Watch our on-demand webinar to delve further into this topic: Adapting Oncology Clinical Research Practices and Therapeutic Development Strategies in the COVID-19 Era.

Adapting oncology clinical research practices and therapeutic development strategies in the covid-19 era

Understanding the impact of COVID-19 on clinical oncology and research

Exploring lessons learned for clinical oncology and research from COVID’s first wave

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