7 Trends In Early Phase Clinical Trials
THE RISKY BUSINESS OF EARLY PHASE TRIALS
Without a doubt, early phase trials are a risky business. An MIT study published in 2018 indicates the probability of success for a compound from Phase I through approval to be about 7-14%. The high variability in cost drivers – staff, clinical site and equipment, patient recruitment, digital data management – necessitate a high level of trial design and management expertise to ensure a cost-effective use of time and budgetary resources so that targets are met without compromising data integrity and regulatory compliance.
EARLY PHASE SUCCESS IS NO GUARANTEE OF FINAL APPROVAL
The most frequently identified reasons for trial failure are study design, site selection, inadequate recruitment, patient burden or safety issues, and poor trial execution. Success in an early phase trial is just the first step along the path to market approval. Therefore, strategic design, proactive business decisions, and meticulous execution are crucial to laying a firm groundwork for subsequent phases. Protocol execution starts with recruitment. Enrolling the right amount of patients or healthy volunteers to make your dataset viable enables advancement in later phase trials.
THE SHIFTING LANDSCAPE OF EARLY PHASE TRIALS
The field of pharmaceutical research is in a perpetual state of flux, with the continuous emergence of new scientific knowledge and the constant refinement of regulatory policy. Sponsors need to be alert to new regulatory developments, while at the same time remaining poised for new opportunities as they arise.
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