The Impact of the COVID-19 Pandemic on Oncology Care and Clinical Trials

Oncology Care ◽

The coronavirus disease 2019 (COVID-19) pandemic has caused considerable global disruption to clinical practice. This article will review the impact that the pandemic has had on oncology clinical trials. It will assess the effect of the COVID-19 situation on the initial presentation and investigation of patients with suspected cancer. It will also discuss the impact of the pandemic on the subsequent management of cancer patients and how clinical trial approval, recruitment and conduct were affected during the pandemic. An intriguing aspect of the pandemic is that clinical trials investigating treatments for COVID-19 and vaccinations against the causative virus, SARS-CoV-2, have been approved and conducted at unprecedented speed. In light of this, this re-view will also discuss the potential that this enhanced regulatory environment could have on the running of oncology clinical trials in the future.

The Impact of the COVID-19 Pandemic on Oncology Care and Clinical Trials

Cancers ◽

10.3390/cancers13235924 ◽

2021 ◽

Vol 13 (23) ◽

pp. 5924

Author(s):

Jennyfa K. Ali ◽

John C. Riches

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Practice ◽

Cancer Patients ◽

Initial Presentation ◽

Regulatory Environment ◽

The Future ◽

Oncology Care ◽

The coronavirus disease 2019 (COVID-19) pandemic has caused considerable global disruption to clinical practice. This article will review the impact that the pandemic has had on oncology clinical trials. It will assess the effect of the COVID-19 situation on the initial presentation and investigation of patients with suspected cancer. It will also review the impact of the pandemic on the subsequent management of cancer patients, and how clinical trial approval, recruitment, and conduct were affected during the pandemic. An intriguing aspect of the pandemic is that clinical trials investigating treatments for COVID-19 and vaccinations against the causative virus, SARS-CoV-2, have been approved and conducted at an unprecedented speed. In light of this, this review will also discuss the potential that this enhanced regulatory environment could have on the running of oncology clinical trials in the future.

Minimizing the Impact of the COVID-19 Epidemic on Oncology Clinical Trials: Retrospective Study of Beijing Cancer Hospital (Preprint)

10.2196/preprints.26799 ◽

2020 ◽

Author(s):

Zhiying Fu ◽

Min Jiang ◽

Kun Wang ◽

Jian Li

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Disease Progression ◽

Remote Monitoring ◽

Management Model ◽

Remote Management ◽

Protocol Compliance ◽

BACKGROUND In view of repeated COVID-19 outbreaks in most countries, clinical trials will continue to be conducted under outbreak prevention and control measures for the next few years. It is very significant to explore an optimal clinical trial management model during the outbreak period to provide reference and insight for other clinical trial centers worldwide. OBJECTIVE The aim of this study was to explore the management strategies used to minimize the impact of the COVID-19 epidemic on oncology clinical trials. METHODS We implemented a remote management model to maintain clinical trials conducted at Beijing Cancer Hospital, which realized remote project approval, remote initiation, remote visits, remote administration and remote monitoring to get through two COVID-19 outbreaks in the capital city from February to April and June to July 2020. The effectiveness of measures was evaluated as differences in rates of protocol compliance, participants lost to follow-up, participant withdrawal, disease progression, participant mortality, and detection of monitoring problems. RESULTS During the late of the first outbreak, modifications were made in trial processing, participant management and quality control, which allowed the hospital to ensure the smooth conduct of 572 trials, with a protocol compliance rate of 85.24% for 3718 participants across both outbreaks. No COVID-19 infections were recorded among participants or trial staff, and no major procedural errors occurred between February and July 2020. These measures led to significantly higher rates of protocol compliance and significantly lower rates of loss to follow-up or withdrawal after the second outbreak than after the first, without affecting rates of disease progression or mortality. The hospital provided trial sponsors with a remote monitoring system in a timely manner, and 3820 trial issues were identified. CONCLUSIONS When public health emergencies occur, an optimal clinical trial model combining on-site and remote management could guarantee the health care and treatment needs of clinical trial participants, in which remote management plays a key role.

Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials—Application of the Estimand Framework

Statistics in Biopharmaceutical Research ◽

10.1080/19466315.2020.1785543 ◽

2020 ◽

Vol 12 (4) ◽

pp. 427-437 ◽

Cited By ~ 2

Author(s):

Evgeny Degtyarev ◽

Kaspar Rufibach ◽

Yue Shentu ◽

Godwin Yung ◽

Michelle Casey ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Exploring cancer clinical trial participation in the new normal of COVID-19: The patient perspective.

10.1200/jco.2021.39.3_suppl.461 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 461-461

Author(s):

Martha Ann Raymond ◽

Margaret-Ann Simonetta

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cancer Patients ◽

Patient Perspective ◽

Ethnically Diverse ◽

Cancer Clinical Trial ◽

Trial Participation ◽

Clinical Trial Participation ◽

Diverse Communities ◽

461 Background: The impact of coronavirus (COVID-19) has significantly affected cancer patients seeking to enroll in a clinical trial. The pandemic has led to an unprecedented disruption across the cancer research community pausing trial operations. Data from the National Institute of Health and the National Library of Medicine indicates 988 cancer clinical trials were suspended from March September 1, 2020, with 60% of institutions enrolling patients at a lower rate. Our research underscores the patient perspective of clinical trial participation amid COVID-19. Methods: July September 2020 Nationwide eight-week online survey and interviews. Research goals: gain a better understanding of barriers and cultural attitudes of ethnically diverse communities regarding trial participation; learn the enhanced safety measures needed for patients to feel comfortable returning to the clinic; better understand the importance of effective patient-clinician communication. Results: 511 patient participants reported the following insights: 86% reported their healthcare team had not discussed trial participation; 99% reported being comfortable with telehealth visits for pre-screening and monitoring; 82% receive care at community-based hospitals. Barriers to enrollment and additional safety considerations include gaps in outreach and education services for ethnically diverse communities; absence of cultural sensitivity and disregard of historical perspective; financial insecurity and travel; and the need for increased COVID-19 testing, enhanced safety protocols and a proven vaccine. Participants identified their ethnicity as 38% Caucasian; 24% Black/African American; 19% Hispanic/Latino; 16% Asian; 2% Native American/Pacific Islander. Conclusions: Clinical trials provide patients access to the newest treatments, and yet only 2%-3% of adult cancer patients enroll in a trial. Common barriers to trial participation have been widely researched, but now amongst the coronavirus pandemic, additional barriers are evident. Based on our research, our call to action is clear: work with key opinion leaders in ethnically diverse populations to help build trust and mutual respect when discussing research studies; and engage patients and clinicians to openly discuss clinical trial enrollment working toward patient-centered communication. The coronavirus pandemic is a devastating public health threat, and it will take a collective effort from the entire cancer community to minimize the effect of COVID-19 on cancer clinical trial participation.

Qualifying sites for oncology clinical trials.

10.1200/jco.2019.37.15_suppl.6619 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 6619-6619

Author(s):

Dax Kurbegov ◽

Edward S. Kim ◽

Patricia A. Hurley ◽

David Michael Waterhouse

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

No Value ◽

Trial Participation ◽

Clinical Trial Participation ◽

Research Organizations ◽

Multi Stakeholder ◽

First Contact ◽

6619 Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and “no-value” steps that impact clinical trial participation. This project assessed the impact of current sponsor and contract research organizations (CRO) methods to evaluate sites for trials. Methods: A survey was conducted with community- and academic-based trial sites. Samples of feasibility questionnaires (FQs) used by sponsors and CROs were also compiled. An ASCO sponsored multi-stakeholder meeting was held to identify strategies to more effectively assess trial sites. Results: 113 oncology practices (63 community, 50 academic) reported completing 11 FQs and 4 pre-study site visits (PSV) on average per month. On average, each FQ took 4 hours (528 hours/site and 59,664 hours for all respondents, annually) and each PSV took 10 hours (480 hours/site and 54,240 hours for all respondents, annually) to complete. Thus, the total staff hours required to complete site feasibility assessments was 113,904 annually. Respondents reported that content in both FQs (82%) and PSVs (91%) was redundant to information previously provided and FQs were redundant between different sponsors (86%). The 42 sample FQs had a median 45 questions (range 13 to 96). Respondents noted that sponsors/CROs provided insufficient study documentation to accurately complete FQs. It took 7 months on average from first contact to first patient enrolled. Respondents also provided feedback about standardizing and streamlining site qualification processes. Conclusions: The current methods of assessing site feasibility for clinical trials poses tremendous burden on site resources and is not sustainable. New methods are needed that standardize, harmonize, and streamline criteria and site assessments. Such changes will reduce burden and costs for all stakeholders, and will expedite and increase patient enrollment onto clinical trials.

Impact on actual clinical practice of the latest evidence for percutaneous closure of patent foramen ovale associated with stroke. A single center experience

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jeaa356.089 ◽

2021 ◽

Vol 22 (Supplement_1) ◽

Author(s):

L Carnero Montoro ◽

M Ruiz Ortiz ◽

N Paredes Hurtado ◽

M Delgado Ortega ◽

A Rodriguez Almodovar ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Patent Foramen Ovale ◽

Cryptogenic Stroke ◽

Percutaneous Closure ◽

Publication Date ◽

Foramen Ovale ◽

Complex Anatomy ◽

The Mean ◽

Abstract Funding Acknowledgements Type of funding sources: None. Background and aims Since september 14th, 2017. Three large clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) was associated with lower recurrence in patients with cryptogenic stroke (CS). Our aim was to determine the impact of these findings on routine clinical practice in a tertiary hospital. Methods Patients with percutaneous closure of PFO due to CS (January 2001-January 2020) were included. The clinical characteristics were analyzed individually and grouped in the RoPE score, before and after the publication date. Complex anatomy (CA) defined as interatrial septum aneurysm or basal wide bubble passage was evaluated in both periods. Results 293 patients were included. The mean age was 49 ± 11 years, 15% were older than 60 years, 60% men, 26% hypertensive, 28% smokers and 7%diabetics. The median RoPEscore was 6 [p25-75, 5-7] and 75% met CA criteria. Since september 14th, 2017, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p <0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and RoPEscore, significantly lower (5 [5-7] vs. 6 [5-7], p = 0.02). Conclusion The publication of clinical trials wich demonstrated the benefit of percutaneous closure of PFO in CS had a significant impact on the daily clinical practice of our institution, with an increase in indications for CA, despite a clinical profile suggestive of lower causal probability of PFO.

Is the future for clinical trials internet-based? A cluster randomized clinical trial

Clinical Trials ◽

10.1191/1740774505cn069oa ◽

2005 ◽

Vol 2 (1) ◽

pp. 72-79 ◽

Cited By ~ 29

Author(s):

Jennifer Litchfield ◽

Jenny Freeman ◽

Henrik Schou ◽

Mark Elsley ◽

Robert Fuller ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Randomized Clinical Trial ◽

The Future ◽

Cluster Randomized

Dedicated clinical trial tissue tracking database to improve turn-around time at high-volume center.

10.1200/jco.2021.39.15_suppl.1543 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 1543-1543

Author(s):

Peter Blankenship ◽

David DeLaRosa ◽

Marc Burris ◽

Steven Cusson ◽

Kayla Hendricks ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Tissue Sample ◽

High Volume ◽

Trial Participation ◽

Fresh Tissue ◽

The Status ◽

Unique Source

1543 Background: Tissue requirements in oncology clinical trials are increasingly complex due to prescreening protocols for patient selection and serial biopsies to understand molecular-level treatment effects. Novel solutions for tissue processing are necessary for timely tissue procurement. Based on these needs, we developed a Tissue Tracker (TT), a comprehensive database for study-related tissue tasks at our high-volume clinical trial center. Methods: In this Microsoft Access database, patients are assigned an ID within the TT that is associated with their name, medical record number, and study that follows their request to external users: pathology departments, clinical trial coordinators and data team members. To complete tasks in the TT, relevant information is required to update the status. Due to the high number of archival tissue requests from unique pathology labs, the TT has a “Follow-Up Dashboard” that organizes information needed to conduct follow-up on all archival samples with the status “Requested”. This results in an autogenerated email and pdf report sent to necessary teams. The TT also includes a kit inventory system and a real-time read only version formatted for interdepartmental communication, metric reporting, and other data-driven efforts. The primary outcome in this study was to evaluate our average turnaround time (ATAT: average time from request to shipment) for archival and fresh tissue samples before and after TT development. Results: Before implementing the TT, between March 2016 and March 2018, we processed 2676 archival requests from 235 unique source labs resulting in 2040 shipments with an ATAT of 19.29 days. We also processed 1099 fresh biopsies resulting in 944 shipments with an ATAT of 7.72 days. After TT implementation, between April 2018 and April 2020, we processed 2664 archival requests from 204 unique source labs resulting in 2506 shipments (+28.0%) with an ATAT of 14.78 days (-23.4%). During that same period, we processed 1795 fresh biopsies (+63.3%) resulting in 2006 shipments (+112.5%) with an ATAT of 6.85 days (-11.3%). Conclusions: Oncology clinical trials continue to evolve toward more extensive tissue requirements for prescreening and scientific exploration of on-treatment molecular profiling. Timely results are required to optimize patient trial participation. During the intervention period, our tissue sample volume and shipments increased, but the development and implementation of an automated tracking system allowed improvement in ATAT of both archival and fresh tissue. This automation not only improves end-user expectations and experiences for patients and trial sponsors but this allows our team to adapt to the increasing interest in tissue exploration.

Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽

10.1136/bmj.k4738 ◽

2018 ◽

pp. k4738 ◽

Cited By ~ 67

Author(s):

Joanna C Crocker ◽

Ignacio Ricci-Cabello ◽

Adwoa Parker ◽

Jennifer A Hirst ◽

Alan Chant ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Clinical Trials ◽

Lived Experience ◽

Odds Ratio ◽

Public Involvement ◽

Meta Analysis ◽

Patient And Public Involvement ◽

Retention Rates ◽

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

Building capacity and ensuring equity in clinical trials during the COVID-19 pandemic.

10.1200/jco.2021.39.15_suppl.e13598 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e13598-e13598

Author(s):

Helen Winter ◽

Joanna Willis ◽

Stephen Lang ◽

Kay Drury ◽

Jonathan Heywood ◽

...

Keyword(s):

Clinical Trials ◽

Informed Consent ◽

Best Practice ◽

Treatment Interruptions ◽

Clinical Ward ◽

The Everyday ◽

The Future ◽

Ward Rounds ◽

Equity Of Access ◽

e13598 Background: The impact on cancer outcomes from the Covid-19 pandemic has yet to be determined. Concerns persist on screening, delays in diagnosis, treatment interruptions and outcomes of infection in the immunosuppressed. The need for agile working has been exemplified by establishment of Nightingale Hospitals, staff redeployment and sudden integration of virtual consultations into clinical working. With most cancer clinical trials halted, recruitment into COVID-19 research became essential and embedded into the everyday. Here we present how rapid implementation of COVID-19 randomised clinical trials within an NHS organisation during the pandemic was achieved. Methods: A COVID-19 senior facilitation committee was set up to provide oversight, maximise staff capacity and resource and prioritise studies. Specific strategies to maximise access and clinical trials recruitment for patients including children and those with solid tumours were designed. These included presence of a research nurse at clinical ward rounds and team meetings, the promotion of protocol and informed consent training to all including doctors in the acute settings and weekly research meetings to share-best practice. Reflecting on learnings from this time provide an opportunity to consider how we adjust working for our patients in the future. Results: The integration of research into the everyday working of clinical teams looking after patients with COVID-19 has become the norm. The provision of protocol and informed consent training for all levels of staff and the consideration of all patients for trials during clinical ward rounds and multi-disciplinary meetings, have ensured access to trials has become embedded. The integration of research nurses working, upskilling and prompting clinical colleagues has ensured equity of access and provided a research presence and focus during the busy clinical day. The adoption of cross-disciplinary working, sharing best practice and a culture of commitment and support to the trials ensures no patient is denied the opportunity to participate. Three RTCs opened over 7 weeks. At one site 1904 patients were screened for one of the randomised-controlled trials and over 18% of these patients (351) were recruited and 175 patients declined. Conclusions: The pandemic has had a devastating impact across the UK. However, a coordinated and collaborative multi-disciplinary approach has supported high recruitment and equity of access for patients into COVID-19 trials. Learnings from this work may lead to embedding clinical trials and access to translational research for cancer patients in the future as we recover from the full impact of the pandemic. COVID-19 research has demonstrated how increased recruitment accelerates access and implementation of new innovations and novel drug combinations.The full impact of improved access to cancer research in the future during COVID recovery is worthy of more research.