214575

• Research type

  Research Study

• Full title

  Time and Motion (T&M) study to quantify time and resources associated with the management and administration of injectable biologics to treat patients with Severe Asthma (SA) and/or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

• IRAS ID

  340292

• Contact name

  Rafael Alfonso

• Contact email

  rafael.x.alfonso@gsk.com

• Sponsor organisation

  GlaxoSmithKline

• Duration of Study in the UK

  0 years, 3 months, days

• Research summary

  In recent years, biologics have become a key component of Severe Asthma (SA) and/or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) treatment as add-on maintenance therapies.

  The purpose of this Time and Motion (T&M) study is to better understand the time taken by Healthcare Professionals (HCPs) and associated costs related to the routine use of injectable biologics to treat SA and/or CRSwNP patients in both clinic and home settings. This study will also aim to capture patient’s perspectives on the burden related to biologic administrations administered in-clinic or at their homes.
  The data that is being collected as part of this T&M study includes the time HCPs dedicate to tasks involved in the management and administration of injectable biologics, e.g., the time spent by the HCP in administering the injectable biologic in-clinic or training the patient for home administration.

  The study will focus on measuring the time taken by HCPs in performing pre-specified tasks related to the administration of injectable biologics. As this is an observational study design, the decision to treat a patient with an injectable biologic to manage their SA and/or CRSwNP will be taken as part of routine clinical practice and is independent of this study.

  As part of this study, participants will be asked to complete a one-time survey about their experience and burden on their caregiver (if applicable) about the management and administration of injectable biologics. The duration of the survey will be approximately 20 minutes.

  This study will be conducted in up to sixteen sites across up to eight countries (China, France, Germany, Italy, Japan, Spain, the UK, and the US) to capture potential geographic differences. The study will be overseen by Syneos Health, the SCC.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  24/PR/0607

• Date of REC Opinion

  25 Jun 2024

• REC opinion

  Further Information Favourable Opinion