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In our two-part interview, Cytel consulting statistician Ursula Garczarek reveals how rare disease development is benefitting from adaptive trial approaches.  In this episode, Ursula shares her insights on current international regulatory perspectives.  Ursula draws from he own considerable experiences, including defending adaptive trial statistical methodologies and their performance before EMA and FDA regulators.

Since it was first introduced over twenty years ago, the predictive simulation technology in today’s East has come a long way.  Biotatistician Lukas Makris has come a long way, too, now an established Independent Consulting Statistician.  In this role, Lukas now helps primarily emerging biotechs and specialty developers determine their optimal early stage clinical strategy. Biotech and specialty portfolio developers typically know their molecule or drug well, but are always seeking greater certainty on how the experimental agent will perform in the clinic.  They initially turn to Lukas to best answer the question: “What research strategy will provide the best opportunity to justify continued development?  And once underway: “Are we progressing accordingly or deviating from plan?”  Today’s East provides Lukas and his client sponsors with answers to these key questions. Fast Answers to "What if…?” Lukas reports that sponsors often want answers to an array of “what if” scenarios: “What if the trial’s subject recruitment lags in the first 3 months, what would be the impact?  What could we expect if we increase the sample size to compensate?”  Their Investors want to better understand the risk and reward trade-offs to formulate the funding strategy.  In fact, Lukas has observed that the biotech investment community is often quite savvy about adaptive approaches.  They appreciate how simulating different scenarios enables quantitative decision-making supporting formulation of the optimal strategy.

Cytel Announces Availability of EnForeSys 2.0 More than half of today’s clinical studies take longer than expected to achieve their enrollment targets, often leading to discontinued trials and expensive failures. EnForeSys [http://www.cytel.com/software/enforesys?utm_campaign=2018_EnForeSys2.0_Launch&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-9dgTqKsqyKzOUXs3-ibQZz6l7iFJ4XiykwpRrqx75NtdoAtWl2FKlQbP1_kqywM8-JPsTd] is the decision tool using modern simulation methods to accurately predict recruitment milestones. Armed with a reliable probability of success, rest assured your trial will achieve target enrollment on time and on budget. New features “Interactive Planner" mode for iterative forecasting: * Closed-form computations allow instant predictions * Set goals on target study duration and site activation Expanded simulation options for more realistic & accurate forecasts: * Study start-up time * Minimum number of patients * Pre-screening * Holidays and seasonal effects * Mid-trial change in enrollment rates What today’s EnForeSys does for you * Produce Data Driven Forecasts: Use historical site-level data and other key factors to accurately predict milestones * Reduce Unpredictability & Improve Trial Success Rates: Advanced simulations calculate a numerical Probability of Success for your strategies * Provide Strategic Insights: Choose the best strategy given resources, flag the potential challenges and pave the way for success * Decrease Planning & Reporting Time: Explain the strategy to clinical teams with easy to communicate analytics * Guarantee Feasibility: Assess whether your projections are realistic using simulations