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 for consumers typically results in increased sales and profitability for pharma and biotech companies. As...
Patient enrollment 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 examined, the capacity of the trial sites to recruit participants, and the degree...
Introduction With the support of patients, regulators, and payers, pharma and biotech companies’ interest in converting prescription drugs (Rx) to over-the-counter (OTC) is growing. In 2021, the sales value of Rx-to-OTC switches was around $35 billion USD. According to Future Market Insights, it is expected to rise at 5.3 percent compound annual growth rate (CAGR),...
The challenge of enrollment for 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 participating? Observational studies, by design, demand a continuation...