Before the 2012 Food and Drug Administration (FDA) Nonprescription Safe Use Regulatory Expansion (NSURE) initiative, sponsors were transitioning prescription drugs (Rx) to over-the-counter (OTC). Streamlined access to effective treatments clearly benefits patients and payers. At the same time, easier access...
Tag: late phase 4 results
Managing clinical trials requires extensive planning of patient enrollment. Clinical trials may be more cost-effective with better forecasts of recruitment. A variety of circumstances influence the enrollment of subjects. Several factors to consider, including the rarity of the condition being...
Real-World & Late Phase
Patient Enrollment and Retention: Overcoming Challenges in Observational Research
Patient enrollment and retention for investigational trials are notoriously difficult. How is enrollment affected when there is no direct benefit to the patient: no breakthrough study drug with the potential to cure, no added caregiver time, no meaningful compensation for...