• Industry: Business Research
  • Study Type: Clinical trial protocol analysis and standards

Background & Key Objectives

  • The study aims to standardize the different elements (such as indications, procedures, endpoints etc.) listed in clinical trial protocols and benchmarking the same indication and therapy areas
  • The engagement for data extraction, standardization and mapping for 500 protocols across multiple therapy areas to be used as an input for Data Sciences team
  • Additionally, study also aimed on assistance in procedure mapping- ‘Tufts procedure to CPT procedure mapping'

Methodology & Approach

  • The data was extracted from different data elements such as Protocol ID, NCT Number, Therapeutic Area, Procedure Name etc.
  • Identifying the number of protocols by indication and therapy area – focus on oncology, respiratory, immunology
  • We standardised the key data elements such as indication, procedures, endpoints, phase of trial etc.
  • Mapping the various endpoints to different procedures of the protocol and assign patient burden for procedures and endpoints
  • We deployed a specialist experienced team with masters in clinical trial research and well versed in analyzing, interpreting and converting medical and clinical research data into high quality output in specified templates

Our Solution

  • We dedicated 3 researchers for 3 months to cover the 500 protocols and deliver as per client satisfaction
  • The study helped the end client understand and analyze different data elements in clinical trial protocol and helped them in mapping various endpoints to different procedures in assessing the burden on the patients while they participate in a clinical trial