Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective

ObjectivesIn 2013, the WHO stated that unless low-income and middle-income countries (LMICs) become producers of research, health goals would be hard to achieve. Among the capacities required to build a local evidence base, ability to conduct clinical trials is important. There is no evidence-based guidance for the best ways to develop locally led trial capacity. This research aims to identify the barriers and enablers to locally led clinical trial conduct in LMICs and determine strategies for their sustainable development.DesignProspective, multiple case study design consisting of interviews (n=34), focus group discussions (n=13) and process mapping exercises (n=10).SettingCase studies took place in Ethiopia (2011), Cameroon (2012) and Sri Lanka (2013).ParticipantsLocal health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were purposively selected through registration searches and snowball sampling (n=100).Primary and secondary outcome measuresDiscussion notes and transcripts were analysed using thematic coding analysis. Key themes and mechanisms were identified.ResultsInstitutions and individuals were variably successful at conducting trials, but there were strong commonalities in the barriers and enablers across all levels and functions of the research systems. Transferable mechanisms were summarised into the necessary conditions for trial undertaking, which included: awareness of research, motivation, knowledge and technical skills, leadership capabilities, forming collaborations, inclusive trial operations, policy relevance and uptake and macro and institutional strengthening.ConclusionsBarriers and enablers to locally led trial undertaking exist at all levels and functions of LMIC research systems. Establishing the necessary conditions to facilitate this research will require multiple, coordinated interventions that seek to resolve them in a systemic manner. The strategies presented in the discussion provide an evidence-based framework for a self-sustaining capacity development approach. This represents an important contribution to the literature that will be relevant for research funders, users and producers.

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Clinical trial conduct in special populations and developing regions: An overview of the DOVE study in pediatric patients with sickle cell disease

Contemporary Clinical Trials ◽

10.1016/j.cct.2017.11.003 ◽

2018 ◽

Vol 64 ◽

pp. 88-94

Author(s):

Stephen G. Reams ◽

Linda Messana ◽

Patricia B. Brown ◽

Kevin Nanry ◽

Alexandria E. Gunnell

Keyword(s):

Clinical Trial ◽

Sickle Cell Disease ◽

Sickle Cell ◽

Pediatric Patients ◽

Special Populations ◽

Cell Disease ◽

Developing Regions ◽

Trial Conduct ◽

Clinical Trial Conduct

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Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

Neuro-Oncology ◽

10.1093/neuonc/noaa015 ◽

2020 ◽

Author(s):

Eudocia Q Lee ◽

Michael Weller ◽

Joohee Sul ◽

Stephen J Bagley ◽

Solmaz Sahebjam ◽

...

Keyword(s):

Clinical Trial ◽

Response Assessment ◽

Primary Brain Tumor ◽

Trial Participation ◽

Cooperative Groups ◽

Clinical Trial Participation ◽

Eligibility Criteria ◽

Trial Conduct ◽

The Impact ◽

Clinical Trial Conduct

Abstract Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

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