The London CTAP network standard operating procedure for averting medications prohibited during clinical trials in cystic fibrosis

Abstract

Objectives Study protocols, particularly for trials with CFTR modulators, specify medications whose use is prohibited due to possible interactions with the IMP. The list can be extensive and participants with cystic fibrosis (CF) and healthcare professionals involved with concomitant medication use may not have ready access to the research protocol. Following an adverse incident in which a patient received a prohibited medication during a clinical trial, the London Clinical Trials Accelerator Platform (CTAP) network developed a comprehensive Standard Operating Procedure (SOP). Methods The SOP was designed by the London CTAP Network, a collaboration of 4 CTAP and 2 affiliate CTAP centres, through joint working between teams of CF clinicians and research coordinators. It describes a simple and systematic approach to educate patients and healthcare professionals, and strategies to minimise the risk of prohibited medication use during clinical trials. Key elements include the creation of educational materials for patients and healthcare providers, enhanced communication and regular communication and updates of shared prohibited medication records. Results The implementation of the SOP involves a step-by-step process, beginning with staff education on the nature of prohibited medications to guarantee adherence to the new protocol, and the collaboration and communication within the different hospitals within the London CTAP Network. Clear and accessible template letters for patients and healthcare professional were developed and distributed, emphasising the importance of strict adherence to prescribed medications. Conclusion Our work presents a robust SOP developed to prevent the unauthorised use of prohibited medications in people with CF participating in clinical trials. To implement and audit this moving forward, the combination of regular communication, adequate education, and network reviews should result in a reduction of this risk and enhanced patient safety.