Download Patient Cognitive Debriefing Brochure

Patient Cognitive Debriefing

In this time of rising costs for clinical trials and increasing importance of patient compliance, it is essential anyone implementing a clinical trial ensures that all documentation used by patients during the trials is optimised to deliver consistent information across different countries and regions.

This is particularly true when there are a number of different languages across the trial sites and trial countries

Patient Cognitive Debriefing (PCD) is used to validate translations by questioning a sample of subjects/patients in the target country as to their understanding of translated documents used by them during clinical trials.

This is of particular interest to those clients undertaking studies using Patient Reported Outcomes and Quality of Life Instruments.

Optimising the patient-related documentation (e.g., diaries) with PCD gives the patient a better level of understanding and consistency of interpretation, leading to greater compliance by the patient and better quality of information recorded by the patient during the trial.

Our service involves:

• Translator and language co-ordinator selection
• Review of source document
• All translations
• Methodology infrastructure for testing the readability of patient documents
• Target country interviewer selection
• Target country subject/patient selection
• Questionnaire design
• Conducting of interviews
• Data collection and validation
• Interpretation of results
• Final reporting

The Patient Cognitive Debriefing (PCD) service offered by Fulcrum Pharma combines expertise in clinical trials with eight years experience in readability testing of patient information and Dora Wirth Languages expertise of translation services to the pharmaceutical industry.

Benefits include:

• Better understanding by patient, giving better compliance
• Consistency of understanding giving consistency of interpretation of results
• More accurate data on a local basis (through compliance)
• More cohesive data on an inter-regional basis

Leading to:

• Better data through accuracy and cohesiveness by patient
• Improved speed to completion of trial and market

>> Back to Top