The Post-COVID Shift to Patient-Centric Cancer Clinical Trials
Updated: Apr 6
Summary in Thirty Seconds
The COVID-19 pandemic notably affected cancer clinical trials, resulting in numerous adaptations in trial protocols and paradigms.
One such adaptation was a shift from a clinical site-centric approach to a patient-centric approach, where the clinical trial “came to the patient” as much as possible.
Examples of such changes include the remote signing of forms, use of alternate labs and clinical sites closer to patients, home delivery of compounds and/or at-home administration of infusion products, decentralized clinical trial conduct, and use of wearable technology.
These changes have resulted in improved patient satisfaction with trials, increased awareness of trials, and better enrollment rates.
Patient-centric cancer clinical trials can lessen restrictive eligibility criteria, foster partnerships with the broader medical oncology community, incorporate telemedicine, and reach underserved populations, thus improving patients’ access to potentially life-saving trials.
COVID-19 Impact on Cancer Clinical Trials
The COVID-19 pandemic produced notable changes in cancer clinical trials. By the end of 2020, numerous clinical trials were running behind in trial launches, site initiations, and patient enrollment goals because systems had not adapted to the restrictions brought on by the pandemic.,, Since then, clinical trial protocols and paradigms have been adapting based on lessons learned from the pandemic. One such change has been the shifting of clinical trials away from a trial site-centric approach to a more patient-centered approach, which is defined as trials that “…prioritize the needs of the patient at all stages, including design, activation, enrollment, data collection, completion and outcome reporting.”
The trial site-centered model was developed over decades to provide strong ethical control of trial conduct and to produce valid and reliable results. However, some of these rules and regulations evolved into place without much challenge or question (the standard answer often being “that’s just how things are done”). The COVID-19 pandemic forced a re-evaluation of the necessity (or not) of key requirements and aspects of trials.
Trial site-centric approach pre-COVID-19
Patient-centric shift post-COVID-19
Mandatory in-person signatures for consent using complex, comprehensive forms
Signed informed consent obtained remotely using more simplified and understandable forms
Use of trial–specified laboratories and imaging
Use of alternate laboratories and imaging centers that meet clinical trial specifications
Recording of safety and clinical assessments by investigators during in-person trial site visits
Use of virtual or over-phone visits for safety and clinical outcome assessments
Require in-person site visits to receive investigational compounds
Home delivery of investigational compounds taken orally and medication reporting through digital tools
Require in-person site visits to receive investigational infusion products
At-home or local HCP provision of infusion products
Limited clinical trial access for underserved populations, resulting in poor diversity in clinical trials
Decentralized clinical trial conduct, giving greater accessibility to rural areas and underserved populations and broadening trials available for patients with a wide range of comorbidities
In-clinic monitoring of vital signs and ancillary measures for adverse events
Use of wearable technology and mobile devices to monitor for signs of adverse events in real-time
Greater Patient Satisfaction and Access
These changes have made clinical trials more “patient-friendly” and have resulted not only in higher participant satisfaction but also greater trial access to traditionally underserved populations while reducing financial burdens to participants. One study found that the use of telehealth consultations for patients with cancer during the pandemic was associated with greater satisfaction ratings than in-person meetings, mainly due to reduced travel time and expense, along with greater convenience. Such convenience most notably affects people in rural areas where it is unlikely there will be easy and close access to major academic cancer centers. Listening to the patient voice makes cancer clinical trials work better for patients in many ways.
Improved Enrollment and Awareness
A more “patient-centric” approach to clinical trials should make recruitment of patients with rare cancers easier. A “site-centric” approach relies on an approach that works best for the investigator and site. But if patients aren’t enrolling and they as well as their HCPs are unaware of the study or eligibility requirements, then ultimately this approach benefits neither sponsors nor patients. Thus, a shift is necessary. One survey of 755 physicians and 1,255 nurses revealed that approximately 70% are interested in referring patients to clinical trials; however, they lack sufficient information and time to identify, evaluate, and discuss clinical trial options with their patients. A patient-centric approach helps build awareness in patients of clinical trials and sites through their activity after diagnosis, most notably in digital media. Awareness can also be built for HCPs through various approaches such as educational efforts. Additionally, using a patient-centric approach has been associated with a notably shorter time to recruit patients in oncology and rare diseases.
Of note, recent trials have incorporated some of these changes to monitor patient conditions outside of the clinical trial site. One study has utilized pulse oximeters at home to identify potential toxicities (e.g., pneumonitis). Another provided at-home testing to monitor biomarker mutations using liquid biopsy techniques during a clinical trial. Additionally, an industry study analyzed more than 90 trial protocols and concluded that approximately 70% of patient data could be collected remotely through virtual visits and noninvasive data collection.
The COVID-19 pandemic taught us that flexibility and adaptability are vital to making cancer clinical trials run better. The safety of patients is still the main priority, but the pandemic has provided insight into bringing the trial to the patient. This gives an opportunity to “improve clinical research by removing restrictive eligibility criteria, fostering partnerships with the broader medical oncology community, incorporating telemedicine and telehealth, [and] reaching underserved populations...” Li et al. assert “We must do better at improving patients’ access to potentially life-saving trials.” A global pandemic appears to have lit a pathway for such improvement.
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