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Blinding of Investigational Medicinal Products (IMPs)
The nature of clinical products under development is changing. With the rise of targeted therapies and the increasing number of oncology clinical trials, biologics are an ever increasing proportion of Investigational Medicinal Products (IMP).
Blinding or masking is intended to limit the occurrence of conscious and unconscious bias in the conduct and interpretation of a clinical trial, arising from the influence that the knowledge of treatment may have on the recruitment and allocation of subjects, their subsequent care, the attitudes of subjects to the treatments, the assessment of end-points, the handling of withdraws, the exclusion of data from analysis, and so on.
In this eBook we highlights the following:
- The changing product landscape
- The benefits of blinding for patients and investigators
- The four common clinical trial designs
- Drug encapsulation blinding methods
- Inhaler blinding methods
- Other dosage forms consideration checklists
- Almac’s approach to blinding clinical trials
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