Client: A Leading Pharmaceutical Company
Challenge:
The client aimed to assess the efficacy and safety of a novel treatment (Drug A) in adult patients with advanced stage cancer harboring specific genetic alterations. The objective was to evaluate its effectiveness alongside standard chemotherapy and immunotherapy options in patients who had previously undergone systemic therapy.
Solution Provided by Clevidence:
Clevidence conducted a systematic literature review (SLR) to gather clinical evidence focused on the target population.
- Systematic Literature Review for Genetic Alterations:
The SLR aimed to identify clinical evidence regarding the treatment of cancer patients with genetic alterations. It primarily included a non-comparative phase II clinical trial and four real-world studies examining outcomes for patients treated with standard therapies. The review consolidated findings related to the efficacy and safety of Drug A, as well as standard therapies used in clinical practice. - Comparative Effectiveness Analysis:
Data was utilized to perform indirect treatment comparisons using individual patient data from the clinical trial and real-world studies to determine the comparative therapeutic value of Drug A against existing treatments.
Results:
The comprehensive analysis provided critical insights into the clinical value of Drug A for patients with advanced stage cancer and the genetic alterations under study. These findings support the Health Technology Assessment (HTA) process, including the comparative effectiveness analysis to determine the added therapeutic value of Drug A.
Conclusion:
Through rigorous research and a focused systematic review, Clevidence enabled the pharmaceutical company to evaluate the role of Drug A in advanced stage cancer, contributing to informed decision-making regarding therapeutic options for this patient population.
