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Page 1 of 16

  • Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned

  • Daniel F. Hanley, Jr, Gordon R. Bernard, Consuelo H. Wilkins, Harry P. Selker, Jamie P. Dwyer, J. Michael Dean, Daniel Kelly Benjamin, Jr, Sarah E. Dunsmore, Salina P. Waddy, Kenneth L. Wiley, Jr, Marisha E. Palm, W. Andrew Mould, Daniel F. Ford, Jeri S. Burr, Jacqueline Huvane, Karen Lane, Lori Poole, Terri L. Edwards, Nan Kennedy, Leslie R. Boone, Jasmine Bell, Emily Serdoz, Loretta M. Byrne, Paul A. Harris
  • Journal: Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
  • Published online by Cambridge University Press: 25 July 2023, e170
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  • New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

  • Psychosocial and Physical Rehabilitation of Burn Survivors: A large multicentre cluster randomised controlled trial from Pakistan

  • N. Chaudhry, M. panagioti, A. B. Khoso, T. Kiran, A. Blakemore, K. Lovell, M. M. Bashir, Z. U. Haq, M. Hashmi, Z. H. Suhag, H. Brooks, E. McIntosh, N. Soomro, S. Falder, L. Kynge, J. Miah, O. Eylem, S. Edwards, R. Memon, S. J. Pocock, Z. Zadeh, I. B. Chaudhry, N. Husain
  • Journal: European Psychiatry / Volume 66 / Issue S1 / March 2023
  • Published online by Cambridge University Press: 19 July 2023, p. S906
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  • Introduction

    Globally, burns are responsible for around 11 million injuries and 180 000 burn-related deaths yearly. Unfortunately, 9 of 10 burn injuries and deaths happen in low-and-middle-income countries (LMICs) such as Pakistan. One in three people admitted to hospitals with burn injuries die within three weeks, and survivors face serious lifelong physical, emotional and psychosocial problems. This may result in anxiety, depression, post-traumatic stress disorder, increased mortality and social disintegration. This study aims to evaluate if implementation of a culturally adapted multidisciplinary rehabilitation programme for burn survivors is clinically and cost-effective, sustainable and scalable across Pakistan.

    Objectives

    • - To understand lived experiences of burn survivors, families, and other stakeholders including the experience of care and impact of burns To work together with key stakeholders (such as burn survivors, family members) to adapt a culturally appropriate affordable burn rehabilitation programme

    • - To undertake social media campaigns to promote burn prevention and risk assessment at communities, workplaces/industries/households; improve first aid; and address burn related stigma

    • - To work with policy makers/parliamentarians to develop national guidelines for burns care and prevention in Pakistan

    Methods

    There are 6 work-packages (WPs). WP1 is to co-adapt a culturally appropriate burn care and rehabilitation programme. WP2 will develop and implement national burn registry on WHO’s initiative. WP3 is a cluster randomised controlled trial to determine clinical and cost-effectiveness in Pakistan. WP4 will evaluate social media campaigns for burn prevention and reduce stigma. WP5 involves working with key-stakeholders for burns-related care and policy and WP6 offers sustainable capacity and capability for burns treatment and rehabilitation.

    Results

    A clinical and cost-effective burn care quality and rehabilitation programme may have a huge potential to save lives and contribute health and socio-economic benefits for patients, families, and the healthcare system in Pakistan. The nation-wide implementation and involvement of burn centres across all provinces offer an excellent opportunity to overcome the problem of burn care access experienced in LMICs.

    Conclusions

    To date, burns prevention, care and rehabilitation have not received sufficient attention in policy initiatives in Pakistan and other LMICs. This study is an excellent opportunity to evaluate culturally adapted burn care and rehabilitation programmes that can be implemented across LMICs. We will disseminate our findings widely, using a variety of approaches, supported by our stakeholder and patient advisory groups.

    Disclosure of Interest

    None Declared

  • Micronutrients and socio-demographic factors were major predictors of anaemia among the Ethiopian population

  • Adamu Belay, Edward J. M. Joy, R. Murray Lark, E. Louise Ander, Scott D. Young, Elizabeth H. Bailey, Martin R. Broadley, Dawd Gashu
  • Journal: British Journal of Nutrition , First View
  • Published online by Cambridge University Press: 10 July 2023, pp. 1-13
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  • Anaemia is characterised by low hemoglobin (Hb) concentration. Despite being a public health concern in Ethiopia, the role of micronutrients and non-nutritional factors as a determinant of Hb concentrations has been inadequately explored. This study focused on the assessment of serum micronutrient and Hb concentrations and a range of non-nutritional factors, to evaluate their associations with the risk of anaemia among the Ethiopian population (n 2046). It also explored the mediation effect of Zn on the relation between se and Hb. Bivariate and multivariate regression analyses were performed to identify the relationship between serum micronutrients concentration, inflammation biomarkers, nutritional status, presence of parasitic infection and socio-demographic factors with Hb concentration (n 2046). Sobel–Goodman test was applied to investigate the mediation of Zn on relations between serum se and Hb. In total, 18·6 % of participants were anaemic, 5·8 % had iron deficiency (ID), 2·6 % had ID anaemia and 0·6 % had tissue ID. Younger age, household head illiteracy and low serum concentrations of ferritin, Co, Cu and folate were associated with anaemia. Serum se had an indirect effect that was mediated by Zn, with a significant effect of se on Zn (P < 0·001) and Zn on Hb (P < 0·001). The findings of this study suggest the need for designing a multi-sectorial intervention to address anaemia based on demographic group.

  • Chapter 12 - Standards and Guidelines for Adaptive Trial Designs and Master Protocols

  • from Part IV - Case Studies of Adaptive Trial Designs and Master Protocols
  • Jay J. H. Park, McMaster University, Ontario, Edward J. Mills, McMaster University, Ontario, J. Kyle Wathen, Cytel, Cambridge, Massachusetts
  • Book: Introduction to Adaptive Trial Designs and Master Protocols
  • Published online: 20 March 2023
  • Print publication: 06 April 2023, pp 140-148

  • Summary

    In this chpater, we review the standards and guidelines for adaptive trial designs and master protocols. Methodological rigour and transparent reporting are required in all clinical trials. Adaptive trial designs and master protocols are no exception. The standard reporting guidelines and risk-of-bias assessments for conventional trials can be applied to adaptive trial designs and master protocols. Adaptive trial designs have pre-planned adaptations and analysis plans that are specified in a formal way that outline how the data will be used to guide the design. Planning of adaptive clinical trials, basket trials, umbrella trials, and platform trials will require early engagement with the stakeholders and methodologists to think through potential hurdles and challenges of the statistical design and its implementation.

  • Chapter 14 - Practical Considerations for Adaptive Trial Designs and Master Protocols

  • from Part V - A Practical Guide to Adaptive Trial Designs and Master Protocols
  • Jay J. H. Park, McMaster University, Ontario, Edward J. Mills, McMaster University, Ontario, J. Kyle Wathen, Cytel, Cambridge, Massachusetts
  • Book: Introduction to Adaptive Trial Designs and Master Protocols
  • Published online: 20 March 2023
  • Print publication: 06 April 2023, pp 160-170

  • Summary

    In this chapter, we review practical considerations for adaptive trial designs and master protocols. Planning adaptive trial designs and master protocols require resources and time. It is best to plan ahead with key stakeholders with statistical, content, and operational expertise to make the trial possible. Customised education and training plans will likely be required for the vendors, investigators, and other personnel involved in the trial. Critical thinking is needed from the personnel involved to create flexible technology systems and procedures required to execute these clinical trials. During the conduct, it is important to document what happened, maintain a proper firewall, and manage external communications effectively. For long-term platform trials, study adjustments may be unavoidable, but it is important that these adjustments are made before the patients are enrolled into the new study arm.

  • Chapter 3 - Characteristics and Principles of Adaptive Trial Designs

  • from Part II - Basic Ingredients for Adaptive Trial Designs and Common Types
  • Jay J. H. Park, McMaster University, Ontario, Edward J. Mills, McMaster University, Ontario, J. Kyle Wathen, Cytel, Cambridge, Massachusetts
  • Book: Introduction to Adaptive Trial Designs and Master Protocols
  • Published online: 20 March 2023
  • Print publication: 06 April 2023, pp 21-27

  • Summary

    This chapter discusses the property and principles of adaptive trial designs. Adaptive trial designs refer to trial designs that offer pre-planned opportunities to modify the design of an ongoing trial based on accumulating trial data. Decisions for potential adaptations are made during the trial based on interim data, but flexibilities in adaptive trial designs are established and outlined in the study documents before any patient is recruited. For statistical planning, a simulation-guided approach is often used to evaluate the statistical properties of the design. It is generally required to demonstrate control of false positive rates for the regulatory, ethics, and funding bodies. Measures to mitigate and plan for operational bias and complexity in adaptive trial designs are needed.

  • Chapter 5 - Clinical Trial Simulations

  • from Part II - Basic Ingredients for Adaptive Trial Designs and Common Types
  • Jay J. H. Park, McMaster University, Ontario, Edward J. Mills, McMaster University, Ontario, J. Kyle Wathen, Cytel, Cambridge, Massachusetts
  • Book: Introduction to Adaptive Trial Designs and Master Protocols
  • Published online: 20 March 2023
  • Print publication: 06 April 2023, pp 47-62

  • Summary

    In this chapter, we discuss the use of simulations for clinical trials. Simulation in statistics generally refers to repeated analyses of randomly generated datasets with known properties. Clinical trial simulation is required to explore, compare, and characterise operating characteristics and statistical properties of adaptive and other innovative trials with complex designs. Clinical trial simulation is an important tool that allows for comparison of different design choices during the planning stage to enhance the quality and feasibility of the trial. While simulations are most frequently used in adaptive and other complex trial designs, they can be applied to fixed trial designs.

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