Evaluation of the effectiveness of additional risk minimisation measures (aRMMs) that aim to reduce the risks of phototoxicity, squamous cell carcinoma (SCC) of the skin and hepatic toxicity in patients receiving voriconazole in Saudi Arabia

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  VFEND
• Study drug International non-proprietary name (INN) or common name:
  VORICONAZOLE
• Anatomical Therapeutic Chemical (ATC) code:
  (J02AC03) voriconazole

  voriconazole

Population studied

• Short description of the study population:
  The target population will include all HCPs who were targeted to receive Vfend® aRMM materials within 12 months preceding the survey in Saudi Arabia (Central, East and North regions). It is important to note that the final survey sample size will depend on HCPs’ willingness to participate in the survey.; ;
• Estimated number of subjects:
  10

Study design details

• Study design:
  The data from the HCPs will be collected using a structured self‑administered questionnaire to gather evaluation metrics related to the utilization and understanding of RM tool content and messages. In addition, the survey will assess behaviors, including a set of hypothetical scenarios for HCPs.
• Main study objective:
  The overall objective of the study is to evaluate the effectiveness of the aRMMs being implemented across Saudi Arabia to mitigate the risks of phototoxicity, SCC of the skin, and hepatic toxicity with the use of voriconazole.
• Setting:
  Given this relatively small pool of HCPs, an empirical sample size of 10 HCPs is proposed. ; ; Participants/ HCPs must meet all of the following criteria to be eligible for inclusion in the survey:; 1. Willing/consent to participate in this self-administered survey.; 2. Involved in the treatment of at least one patient with voriconazole within the last 12 months.; ; Participants/ HCPs meeting any of the following criteria will not be included in the survey:; 1. Employed in full-time research or hospital administration (i.e., non practicing physicians).; 2. Employment by Pfizer Inc or any research organization/vendor contracted by Pfizer to administer the survey.
• Outcomes:
  1. Estimate the proportion of targeted HCPs who acknowledge receiving the tools.; 2. Estimate the proportion of targeted HCPs who acknowledge reading and utilizing the tools.; 3. Estimate the proportion of targeted HCPs who responds correctly to questions about the risks of phototoxicity, SCC of the skin, and hepatic toxicity.; 4. Estimate the proportion of targeted HCPs who provided desirable responses to the practice-related questions and self-declared behavior with regard to strategies to mitigate the risks.
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for HCPs’ responses to all questions that address the survey objectives.