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Blinding01:11

Blinding

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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Evaluating blinatumomab implementation in low- and middle-income countries: a study protocol.

Caitlyn Duffy1, Victor Santana2,3, Hiroto Inaba2

  • 1Department of Oncology, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA. Caitlyn.duffy@stjude.org.

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|June 11, 2022
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Summary

This study develops a roadmap to implement novel pediatric cancer therapies, like blinatumomab, in low-resource settings. The goal is to improve access and care for children with B-cell acute lymphoblastic leukemia (B-ALL) globally.

Keywords:
Acute lymphoblastic leukemiaConsolidated Framework for Implementation ResearchImplementation scienceLow- and middle-income countriesNovel therapiesOncologyResource-poor settings

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Area of Science:

  • Pediatric Oncology
  • Implementation Science
  • Global Health

Background:

  • Novel therapies are advancing pediatric cancer care but face significant resource barriers in low- and middle-income countries (LMICs).
  • Limited access to treatments like blinatumomab (bispecific antibody therapy for B-cell acute lymphoblastic leukemia [B-ALL]) hinders survival rates in LMICs.
  • This study addresses the need for a model to support novel therapy implementation in resource-limited settings.

Purpose of the Study:

  • To develop a model supporting the implementation of novel therapies in LMIC centers.
  • To create an implementation framework for novel therapies, starting with blinatumomab for B-ALL.
  • To enhance global access to advanced pediatric cancer treatments.

Main Methods:

  • Mixed methods approach integrating qualitative and quantitative data collection.
  • Utilizing the Consolidated Framework for Implementation Research (CFIR) to guide evaluation.
  • Conducting semi-structured interviews, organizational assessments, and feasibility/acceptability/appropriateness/cost analyses.
  • Assembling a multidisciplinary team of global healthcare professionals, industry experts, and implementation scientists.

Main Results:

  • The study will identify key contextual factors influencing novel therapy implementation.
  • It will assess the feasibility, acceptability, appropriateness, and cost of blinatumomab administration.
  • Stakeholder perceptions of various implementation strategies will be quantitatively evaluated.

Conclusions:

  • A rigorous implementation roadmap for novel therapies in low-resource settings will be developed.
  • Formative assessment findings will pinpoint priority areas and effective implementation strategies.
  • The roadmap will facilitate scale-out strategies, increasing access and capacity for pediatric cancer care in LMICs.