Operational complexity versus design efficiency: challenges of implementing a phase IIa multiple parallel cohort targeted treatment platform trial in advanced breast cancer.

BACKGROUND: Platform trial designs are used increasingly in cancer clinical research and are considered an efficient model for evaluating multiple compounds within a single disease or disease subtype. However, these trial designs can be challenging to operationalise. The use of platform trials in oncology clinical research has increased considerably in recent years as advances in molecular biology enable molecularly defined stratification of patient populations and targeted therapy evaluation. Whereas multiple separate trials may be deemed infeasible, platform designs allow efficient, parallel evaluation of multiple targeted therapies in relatively small biologically defined patient sub-populations with the promise of increased molecular screening efficiency and reduced time for drug evaluation. Whilst the theoretical efficiencies are widely reported, the operational challenges associated with these designs (complexity, cost, regulatory, resource) are not always well understood. MAIN: In this commentary, we describe our practical experience of the implementation and delivery of the UK plasmaMATCH trial, a platform trial in advanced breast cancer, comprising an integrated screening component and multiple parallel downstream mutation-directed therapeutic cohorts. plasmaMATCH reported its primary results within 3 years of opening to recruitment. We reflect on the operational challenges encountered and share lessons learnt to inform the successful conduct of future trials. Key to the success of the plasmaMATCH trial was well co-ordinated stakeholder engagement by an experienced clinical trials unit with expert methodology and trial management expertise, a federated model of clinical leadership, a well-written protocol integrating screening and treatment components and including justification for the chosen structure and intentions for future adaptions, and an integrated funding model with streamlined contractual arrangements across multiple partners. Findings based on our practical experience include the importance of early engagement with the regulators and consideration of a flexible resource infrastructure to allow adequate resource allocation to support concurrent trial activities as adaptions are implemented in parallel to the continued management of patient safety and data quality of the ongoing trial cohorts. CONCLUSION: Platform trial designs allow the efficient reporting of multiple treatment cohorts. Operational challenges can be overcome through multidisciplinary engagement, streamlined contracting processes, rationalised protocol and database design and appropriate resourcing.

Operational challenges during a pandemic: an investigation in the electronics industry

PurposeThe recent coronavirus disease 2019 (COVID-19) pandemic poses numerous challenges to supply chains. This pandemic is quite unique when compared to previous epidemic disruptions and has had a severe impact on supply chains. As a result, the operational challenges (OCs) caused by COVID-19 are still unknown among practitioners and academics. It is critical to comprehensively document current OCs so that firms can plan and implement strategies to overcome them. Consequently, this study systematically identifies and ranks COVID-19-related OCs.Design/methodology/approachThis study uses an integrated methodology combining expert interviews and the best-worst method (BWM) to analyze the results. The data have been collected from the electronics industry of Bangladesh, an emerging economy. This study also conducts a sensitivity analysis to check the robustness of the results.FindingsThe results reveal 23 COVID-19-related OCs under five categories: sourcing, production and inventory management, demand management and distribution, return management and after-sales service, and supply chain-wide challenges. The quantitative investigation reveals that overstock in finished goods inventory, low end-customer demands, order cancellations from dealers and retailers, high inventory holding costs and lack of transportation are the top five OCs.Practical implicationsThe findings will help practitioners to understand the OCs and allow them to prepare for future major disruptions and formulate long-term strategies for operations during and after the COVID-19 pandemic.Originality/valueThis study contributes to the literature on supply chain complexity and challenges by considering a major pandemic outbreak. Moreover, the study also contributes to the knowledge on emerging economies, which have been largely neglected in the current literature.

Operational challenges in a US nonprofit network amid COVID-19: Lessons from a food network in Virginia.

The coronavirus pandemic (COVID-19) had detrimental health and economic impacts on communities across the globe. Consequently, public, profit and nonprofit organizations had to quickly adjust to the new situation and adopt new operating strategies and service delivery mechanisms. This study examines a nonprofit food network in Virginia and the impact of COVID-19 on food bank services and distribution operations. Guided by the adaptive systems approach, this case study utilizes the Federation of Virginia Food Bank (FVFB) and focuses on operational challenges within the network and the impact of the CARES Act. The data obtained from stakeholder interviews and a survey of local and regional providers suggest communication and adaptive management were crucial in the continuation of network operations. Furthermore, understanding the multifaceted needs of vulnerable individuals, beyond nutrition and food insecurity, is important for nonprofit service partners in a network. The study proposes a conceptual framework for effective operations in a nonprofit network during crisis and highlights the need to create collaborative capacity.

Operational challenges in the pre-intervention phase of a mental health trial in rural India: reflections from SMART Mental Health.

BACKGROUND: Availability of mental health services in low- and middle-income countries is largely concentrated in tertiary care with limited resources and scarcity of trained professionals at the primary care level. SMART Mental Health is a strategy that combines a community anti-stigma campaign with a primary health care workforce strengthening initiative, using electronic decision support with the goal of better identifying and supporting people with common mental disorders in India. METHODS: We describe the challenges faced and lessons learnt during the pre-intervention phase of SMART Mental Health cluster Randomised Controlled Trial. Pre-intervention phase includes preliminary activities for setting-up the trial and research activities prior to delivery of the intervention. Field notes from project site visit, project team meetings and detailed follow-up discussions with members of the project team were used to document operational challenges and strategies adopted to overcome them. The socio-ecological model was used as the analytical framework to organise the findings. RESULTS: Key challenges included delays in government approvals, addressing community health worker needs, and building trust in the community. These were addressed through continuous communication, leveraging support of relevant stakeholders, and addressing concerns of community health workers and community. Issues related to use of digital platform for data collection were addressed by a dedicated technical support team. The COVID-19 pandemic and political unrest led to significant and unexpected challenges requiring important adaptations to successfully implement the project. CONCLUSION: Setting up of this trial has posed challenges at a combination of community, health system and broader socio-political levels. Successful mitigating strategies to overcome these challenges must be innovative, timely and flexibly delivered according to local context. Systematic ongoing documentation of field-level challenges and subsequent adaptations can help optimise implementation processes and support high quality trials. TRIAL REGISTRATION: The trial is registered with Clinical Trials Registry India (CTRI/2018/08/015355). Registered on 16th August 2018. http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=23254&EncHid=&userName=CTRI/2018/08/015355.