To treat or not to treat, that is the question.
COVID-19 has impacted all aspects of clinical care globally – no doubt. Amid monumental efforts put in place by national health systems to repurpose existing resources, infrastructure and wards as well as building new, dedicated hospitals to manage these patients, a perhaps less visible, yet significant, highly vulnerable population has been severely impacted: those living with cancer.While this piece will focus on the latter, the clear negative effects that have been observed on cancer screening programs as well as the delay in basic cancer research and early-stage drug discovery activities should also be noted.
On the one hand, most cancer patients cannot wait until the pandemic resolves to receive treatment or undergo surgery; on the other, they are at a higher risk of contracting and experiencing adverse effects from this strain of the Coronavirus. Over the past few months, oncologists have been trying to strike a balance between mitigating their patients’ risk of potential exposure and continuing to ensure access to cancer treatments and clinical trials. An additional consideration that has taken centre stage is how to ensure the safety of healthcare workers while optimising services.
Major oncology associations like ASCO and ESMO have developed guidelines for cancer care at this extraordinarily challenging time, and multiple articles providing practical advice and recommendations by groups of oncologists and single institutions are also being published. General considerations for healthcare providers include: Can treatment be given in alternative regimens (e.g. less frequent dosing or shorter in duration)? In a less medicalized environment (e.g. local clinics)? Via other modes of administration to minimise patient exposure and maximise resources (e.g. changing intravenous administration to subcutaneous or oral, if available)?
Considering this, it goes without saying that cancer therapies with less intensive treatment regimens and, as a consequence, fewer visits to healthcare facilities could gain a competitive edge over competitors, such as the recently approved Merck’s Keytruda at 400 mg six-weekly instead of 200 mg three-weekly. Pharmaceutical companies offering oral drug, shipped directly to a patient’s home, are also better positioned than their counterparts providing IV-infused treatment.
In addition, the immediate work-around of switching face to face patient consultations to telemedicine, online and smartphone platforms is gaining traction and high levels of adoption, likely to have an impact on future standards of care.
In cases where treatment cannot be postponed or administered in the outpatient setting, oncologists are required to define and apply prioritization criteria for their patients based on treatment intent and risk-benefit ratios. The type of tumor, the level of immunosuppression associated with an individual therapy as well as potential comorbidities and the impact of COVID-19 transmission in the local community also need to be taken into account. The question of future impact on clinical decision-making also applies.
But what about cancer patients who are suspected of, or confirmed with, a COVID-19 infection? Among many other initiatives, ESMO has launched an international collaborative project, the ESMO-CoCARE Registry, to quickly gather data and information from healthcare professionals about treatment approaches specifically focusing on this subset. Pooling real-world data will allow oncologists to gather and share knowledge in near real-time, which will, in turn, inform patient and caregiver decision making.
Reinventing clinical trials
One area of cancer care that has been especially disrupted by COVID-19 is how clinical trials are being conducted. Sponsors and investigators now need to comply with regulations and public health guidance to prevent patient and staff exposure to COVID-19 and may be unable to fulfil all the pre-specified requirements within the original time frame. Testing/dosing procedures may also be delayed. This may lead to protocol modifications (intentional or unintentional) with potential consequences on the level of data that can be gathered as well as patient accrual.
In general, study coordinators are changing the way that they work tracking changes in enrolled patients’ health, leveraging digital tools such as e-signature for informed consent and other paperwork, moving consultations to a virtual format where face to face is not critical, monitoring adverse events and side effects through online portals as well as many other tools. Just as importantly, communication with patients should be pro-active, keeping patients abreast of any changes to study procedures and timelines to reduce stress and anxiety in this turbulent time.
Every cloud has a silver lining
While the end date of this pandemic in unclear, what is certain is that many aspects of cancer care will not be the same in the COVID-19 aftermath.
Increasing utilization of telehealth will represent a major paradigm shift from conventional diagnostic and treating practices: new professional clinical roles will start to appear, to ensure clear and transparent communication in every aspect of the patient-physician virtual interaction; psychological support will also become increasingly important alongside pharmacological therapy in the cancer patient journey.
For clinical trials, the hope remains that operational efficiencies achieved during the pandemic will result in more patient-centred approaches after it, improving time and financial expenditure for all stakeholders. The research community is currently evaluating how best to streamline recruitment and treatment procedures while retaining the same scientific integrity and rigour of the pre-pandemic protocols. More flexible study designs and timelines coupled with reduced data collection requirements and fewer in-person visits to the trial sites could highly benefit cancer patients and caregivers without negative consequences on science quality.
Learn more about how CHR analyse and evaluate changing markets and commercial landscapes through competitive intelligence in healthcare and pharma.