The Product Lifecycle: - ICON plc

Clinical Research
Clinical Development Support
Patient-reported data is an important source of information in
registration studies. We provide multiple services supporting
Phase I–III global clinical trials:
• Development and Validation of Patient Reported
Outcomes (PROs)
• Translation and Cultural Adaptation of PROs to be
included in clinical trials
• PRO dossier and document submissions for the FDA
• Selection of Endpoints for Patient or Economic Outcomes
• PRO Data Collection (electronic and paper)
• Data Analysis of PRO and Economic Endpoints
• Site Support for PRO data collection
• ROC analysis for PMAs
Post-Approval Research
We can provide advice and operational support for clinical and
commercial activities after drug registration in the following areas:
• Product Registries
• Community Surveys
• Epidemiologic Studies and Prospective Disease Registries
• Safety Surveillance
• Retrospective Chart Reviews
• Administrative Claims Analyses
• Reimbursement Support
• Decision-Analytic Models
• Comparative Effectiveness Studies
• Non-interventional Phase IV Clinical Trials
• Educational Interventions for Providers or Patients
• Post-Hoc Analysis of Registrational Studies
Challenge:
Our client wished to submit a PRO claim (to be submitted
to the FDA) related to patient reported symptoms associated
with an investigational therapy. The PRO instrument was
selected for the Phase III trial prior to Lifecycle Sciences
group involvement.
Challenge:
Our client asked Lifecycle Sciences group to evaluate
an educational intervention to improve compliance
with treatment guidelines for patients receiving care at
community-based oncology practices.
Solution:
• Provided strategic consulting for obtaining a PRO label
• Developed the conceptual model, endpoint model, and
conceptual framework to support the instrument selection
• Conducted targeted literature searches
• Convened several Scientific Advisory Panel meetings to review
study materials
• Adapted, validated, and pilot tested the instrument to be used in
the clinical trials
• Conducted the statistical analysis of the PRO data
• Developed a comprehensive PRO dossier for submission to
the FDA
Solution:
• Provided strategic consulting on study design and
implementation, including design of the chart review study
pre- and post-intervention
• Assisted with development of protocol and case report forms
(CRFs) for both pre- and post-intervention data collection
• Trained and provided oversight to chart abstractors who
abstracted data pre- and post-educational intervention
• Managed data collection
• Developed the statistical analysis plan and analyzed the data
• Developed multiple abstracts and a published manuscript
3