Optimizing Global Clinical Trial Enrollment: A Case Study That Can Save You Millions

Held March 19, 2009

On average, 60 percent of R&D budgets are spent on trials, double what it was 20 years ago. Yet, for all the additional expenses, sponsors are getting diminishing returns as at least one-third of trials fail to meet their enrollment goals.

Why? Drug and biologic makers are using simplistic predictions that don’t take into account such real-life variables as disease prevalence in a particular country or the possibility that patients will not enroll in a trial.

But there is an answer.

VOI Consulting’s Todd Clark recently forecasted patient enrollment for a trial of a cancer treatment in 23 countries for a top-10 pharmaceutical firm. The results demonstrated that the company could meet its recruitment goals and save $4 million at the same time by eliminating seven countries and 24 sites from its original plan.

How did he do this? By using what is called Monte Carlo Analysis — a mainstay of predicting results in such highly variable situations. Todd ran 10,000 computer simulations of patient enrollment for each country that took into account all the known variables and produced reliable estimates of where the sponsor would and wouldn’t meet its enrollment goals.

And, now, he’ll show you how …

VOI Consulting President Todd Clark will show attendees the difference between standard models and the Monte Carlo Analysis and where the dangerous spots in the data are. In addition, you’ll watch as he runs a real-time demonstration of 10,000 enrollment simulations and shows how the results influenced the sponsor’s initial assumptions regarding the trial’s scope, depth and cost.

Order now for your entire team to listen in and discover:

  • The four key steps in constructing the enrollment model
  • The few variables sponsors can control and the many more they cannot
  • The inherent flaws in standard analyses and how they negatively affect a trial
  • The benefits of using Monte Carlo Analysis in predicting enrollment
  • An online, real-time demonstration of running 10,000 enrollment simulations
  • How the resulting predictions were used to advise the sponsor which countries to target and which ones to avoid, cutting eight percent of the trial’s budget.
This audio CD/Transcript will show you how using this analytical technique can help you meet enrollment goals on time, reducing the time to bring a product to market.
This audio CD/Transcript is a must for drug and biologic firm employees charged with putting together a strategy for a successful clinical trial, including:
  • Drug development officers
  • Clinical project specialists
  • Clinical managers
  • CRO specialists
  • General/corporate counsel
  • Consultants/service providers
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Todd Clark is the president of Value of Insight Consulting, Inc. (VOI), a life sciences advisory firm, and the author of many pharmaceutical industry publications, including PharmaHandbook and Generic Handbook. During nearly 20 years' experience in the life sciences field, he has consulted with 11 of the top 15 drug companies, as well as leading biotech firms, investment banks and cutting-edge health technology services — advising them on market entry, clinical trial design, regulatory compliance, marketing strategy, forecasting, competitive intelligence, pricing, allocation of sales-force resources, promotional programs and more.

Todd is a graduate of Tulane University and has an MBA from the Kellogg School of Management at Northwestern University, where he majored in strategy, finance and marketing. In addition to his duties with VOI, he has taught courses in marketing, business strategy and managerial decisionmaking at Loyola University and Tulane University. For the latter institution, he developed a healthcare management curriculum and taught healthcare policy, payment and regulation within that program. In addition, he serves on the Business Studies Advisory Group for Tulane.

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