The Changing Product Landscape
With the rise of targeted therapies and the increasing number of oncology clinical trials, biologics are an ever increasing proportion of Investigational Medicinal Products (IMPs) in development.
This change pose challenges for clinical supply professionals who continually need to provide blinded supplies for clinical programs.
Common Trial Designs
Clinical trial designs generally fall into one of the following categories:
- Open: The patient and the investigator are aware which drug is being taken.
- Single blind: The patient isn’t aware of which drug is being taken.
- Double blind: Neither the patient nor the investigator is aware of which drug is being taken.
- Double Dummy – Patient and Investigators are blinded. Patients are given IMP and placebo drug together. Investigators give different combination of IMP and placebo medication to patients
- Third party blind – The medication itself is dispensed by a third party such as a doctor, nurse or a pharmacist. Neither the patient nor the investigator could recognise the medication. The medication itself isn’t blinded.