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P119: Design and Implementation of Blinding Procedures for Blood Products in the VA During the COVID-19 Pandemic

Poster Presenter

Elliott Miller

Clinical Research Pharmacist
Department of Veterans Affairs
United States

Objectives

To rapidly implement clinical trial blinding procedures on blood products in order to maintain data integrity.

Method

Using “VA CoronavirUs Research and Efficacy Studies-1” (VA CURES-1) as a prototypical study using blood product investigational agents, we implemented blinding strategies using a multi-disciplinary team, leveraging strengths of involved parties while adhering to strict regulatory requirements.

Results

Between April through November 2020, procedures to blind normal saline (NS), a control arm as the COVID-19 convalescent plasma (CCP) comparator, were developed, creating NS that was indistinguishable from active CCP in the electronic health record, and physically obscured the view of the product by the participant and/or the study team. In order to implement this blind, procedures were developed that addressed the following concerns: custody of investigational CCP needed to remain with the clinical pathology team until the time of transfusion, custody of NS and blinding materials needed to remain with unblinded research staff (i.e., investigational drug pharmacists), and the transfusion of investigational product needed to be performed by clinical staff where product identification at the time of transfusion was essential. Additionally, the procedures developed for VA CURES-1 required the incorporation of aspects of investigational drug pharmacy and clinical pathology workflow to allow for each entity to maintain autonomy while performing these tasks. One key barrier to operationalizing this blind was the electronic integration of blinded product for NS to resemble CCP. For NS to be handled, inventoried, ordered, and distributed or administered as a blood product, it was required to be labeled with an International Standard of Blood Transfusion-128 (ISBT-128) which additionally allowed for NS to incorporate with clinical pathology’s (i.e., blood bank services’) inventory management system. Another key barrier of operationalizing the blind was physical masking of the product to ensure the participant and blinded study team members (e.g., site coordinators) remained unaware of the study product being transfused. Physical blinding was achieved using IV bag and tubing covers, which obstructed view of the product during transfusion, however allowed for rapid identification of the product by the transfusing medical professional.

Conclusion

By identifying and addressing all barriers to operationalization of the blinding procedures, we successfully implemented a clinical trial using a placebo-controlled blinded design for an active blood product. Through describing the methods used for blinding investigational blood products for use in a multicenter clinical trial setting, the knowledge and experience of this research endeavor is intended to serve as means to foster improved implementation of similar procedures for blinding investigational biological therapeutics for future research projects. A clear and focused description of the methodology should be utilized for future, high-quality research studies, especially those executed in an expedited fashion. In identifying the barriers to implementation of such a blinded design, the outcomes of this endeavor could additionally serve to inform future advances for ease of integration of distinct teams on various research endeavors.