Clinical trial planning and reporting
Introduction
Our experts supported two separate phases II, randomized, double-blind, placebo-controlled trials to evaluate two candidate vaccines (Rotarix and Pneumovax) in multiple settings.
About the Client
Both companies are among the leading multinational pharmaceutical companies in the world
Business Issues
- Appropriate plans and designs of the trial (e.g., Randomized? Equivalence?)
- Background reviews and data quantification (e.g., incidence/ prevalence rates) needed to inform the design
- Development of international-standard scientific and operational protocols
- Selection of appropriate trial patients and hospitals
- Train site staff to conduct trial according to Good Clinical Practice guidelines
- Monitor progress, analyze and interpretation of the trial data
Business Consulting Solution
In phase one, following a thorough systematic review, we developed the rationales for the trials. We calculated the initial burden of the diseases in question and estimated the expected efficacy. We defined the primary objective as conducting phase II, randomized, double-blind, placebo-controlled trials to evaluate the vaccines’ immunogenicity, reactogenicity, and safety in question. We developed the scientific and operational protocols based on the available best practices globally. In phase two, we selected the trial sites, conducted a series of staff training, then coordinated and monitored the trial activities. Once the trials were completed, we helped analyze the data.
Results
These trials have shown that immunization with these candidate vaccines has substantial benefits to reduce respiratory and gastrointestinal illness for both mothers and infants.
