Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial

Abstract THR1VE! is an ongoing multisite randomized clinical trial of a positive psychology intervention designed to treat diabetes distress and improve glycemic outcomes in teens with type 1 diabetes. Due to the COVID-19 pandemic restrictions on clinical research and changes in diabetes clinical care, THR1VE! was adapted from an in-person enrollment protocol to a remote protocol through a series of development and testing strategies. We discuss the process of transitioning the protocol and the demonstrated feasibility of ongoing recruitment, enrollment, and retention outcomes. These findings offer support for a remotely transitioned protocol that has larger applications for ongoing and future clinical research.

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The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute

JNCI Journal of the National Cancer Institute ◽

10.1093/jnci/djaa144 ◽

2020 ◽

Cited By ~ 1

Author(s):

Sara M Tolaney ◽

Christine A Lydon ◽

Tianyu Li ◽

Jiale Dai ◽

Andrea Standring ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Research ◽

Statistical Significance ◽

Median Number ◽

Lessons Learned ◽

Interventional Treatment ◽

Serious Adverse Events ◽

Drug Dosing ◽

Dana Farber Cancer Institute ◽

The Impact

Abstract Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19–related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients.

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Lessons learned from a clinical-research partnership in outpatient palliative care.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.26_suppl.238 ◽

2016 ◽

Vol 34 (26_suppl) ◽

pp. 238-238 ◽

Cited By ~ 1

Author(s):

Mary Cunningham ◽

Karla T Washington ◽

Diane L Huenke

Keyword(s):

Clinical Trial ◽

Palliative Care ◽

Clinical Research ◽

Lessons Learned ◽

Care Providers ◽

Research Partnership ◽

Care Clinic ◽

Broadband Internet ◽

Rural Caregivers ◽

Weekly Meeting

238 Background: Palliative care providers and investigators at the University of Missouri developed a clinical-research partnership to conduct a randomized clinical trial (R21CA191165; NCT02427490; PI: Washington) of a technologically-mediated intervention for family caregivers of cancer patients aimed at decreasing caregivers’ distress and improving their quality of life. As the first year of the project drew to a close, the clinician-research team sought to systematically examine the challenges they had encountered conducting research in the outpatient palliative care clinic, which serves a 91-county catchment area that is highly rural and underserved, and to document the strategies they had employed to address them. Methods: Researchers conducted a content analysis of all weekly meeting notes and communication (i.e., emails, memos) related to Year 1 of the project, identifying major categories of identified challenges and related solutions. Results were presented to other members of the team for verification and/or clarification of key points. Results: Researchers identified five categories of challenges and related strategies: adapting processes and materials for use earlier in the cancer trajectory, accommodating a broad range of literacy levels, reaching rural caregivers, responding to technological constraints, and integrating research into the clinic workflow. Selected strategies included consultation with a Patient Advisory Board to revise recruitment materials, broadening inclusion criteria to accommodate rural caregivers without broadband internet availability in their communities, and establishing processes to allow researchers to meet with potential participants between scheduled appointments during busy clinic days. Conclusions: There are many unique considerations clinicians and researchers should take into account when developing partnerships in outpatient palliative oncology settings, particularly within predominantly rural, publicly-funded health care systems. While challenging to develop, such partnerships are instrumental in establishing an evidence base for care for individuals who are otherwise often underrepresented in large research projects. Clinical trial information: NCT02427490.

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The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

10.2196/preprints.17630 ◽

2019 ◽

Author(s):

Allison Hirsch ◽

Mahip Grewal ◽

Anthony James Martorell ◽

Brian Michael Iacoviello

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Scoping Review ◽

Digital Technologies ◽

Good Clinical Practice ◽

The United States ◽

Clinical Trial Research ◽

Digital Methods ◽

Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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Cellular Therapy During COVID-19: Lessons Learned and Preparing for Subsequent Waves

Transplantation and Cellular Therapy ◽

10.1016/j.jtct.2021.02.011 ◽

2021 ◽

Cited By ~ 1

Author(s):

Mariam T. Nawas ◽

Gunjan L. Shah ◽

Darren R. Feldman ◽

Josel D. Ruiz ◽

Elizabeth V. Robilotti ◽

...

Keyword(s):

Cellular Therapy ◽

Lessons Learned

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In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽

10.1186/s13063-020-05002-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Aldo Badano

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Medical Devices ◽

In Silico ◽

Lessons Learned ◽

Patient Access ◽

High Quality ◽

Virtual Imaging ◽

Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

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Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

Applied Clinical Informatics ◽

10.1055/s-0041-1727153 ◽

2021 ◽

Vol 12 (02) ◽

pp. 293-300

Author(s):

Kevin S. Naceanceno ◽

Stacey L. House ◽

Phillip V. Asaro

Keyword(s):

Clinical Trial ◽

Emergency Department ◽

Clinical Trials ◽

Clinical Research ◽

Substantial Reduction ◽

Text Message ◽

High Volume ◽

Text Messages ◽

Shared Task ◽

Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

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