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Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines

Audio conference highlights


One of the greatest risks to successful drug development today is delayed clinical development timelines. Detailed planning and appropriate site and country selection is the most critical factor in meeting target patient accrual goals within the planned timeline. Historically, site and country selections have been made primarily utilizing survey-based prospective feasibility. Unfortunately, survey-based feasibility alone is no longer sufficient to provide the detail necessary to select countries and sites to maximize patient accrual and minimize development timelines. An evidence-based methodology approach coupled with survey-based feasibility provides the most accurate forecast for patient accrual and the selection of sites and countries with the highest likelihood of being productive.


This audio conference discusses the key items of an evidence-based approach to feasibility and ultimately, site and country selection.


This audio conference covers:


  • Data mining of available databases, both public and private
  • Cross referencing of epidemiologic data with customary care and standard of care data
  • Evaluation of recently published papers and abstracts, and the potential effect on standards of care
  • Mining and analysis of the competitive landscape by region
  • Insurance coverage and reimbursement issues
  • Detailed evaluation of cross referencing of available patients and investigators
  • Comparator drugs and local availability


About the speaker:


Kent Thoelke is Senior Vice President of Scientific & Medical Affairs, Therapeutic Expertise for PRA International, a global CRO with 3,200 employees, covering 65 countries on 6 continents. He has over 19 years of experience in the global drug development and device industry, having held positions in both clinical and corporate development in multinational R&D companies as well as small and emerging biotechnology companies. Most recently Mr. Thoelke has spent the last 8 years in the global CRO environment.


Mr. Thoelke has participated in the development of drugs and therapies in the oncology area from discovery to pivotal trials. This has given him a broad depth of experience in both global clinical development as well as in working with regulators on approval strategies. Having visited over 40 countries, he is very familiar with the global drug development environment, and has established relationships with therapeutic experts in numerous oncology indications around the world. Mr. Thoelke has spoken widely regarding the current landscape of clinical trial recruitment and its effect on drug development timelines. He is active in pursuing novel technologies and strategies to move the current clinical drug development paradigm away from anecdotal strategy to a more focused evidence based strategy.


Who should attend?


  • Chief Medical Officers
  • Heads of Feasibility and/or Patient Recruitment
  • Program Directors
  • Therapeutic Area Leaders
  • Directors of Clinical Operations


*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.

Product Details

Kent Thoelke, PRA International
Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines
Title: Sr. Vice President of Therapeutic Expertise, Scientific & Medical Affairs
Duration: 60 minutes
Discount: Buy 2 items, get 25% off your order using coupon code FX25%OFF
Event Type: Previously recorded on 2009-03-25
Item #: ac20090325
25 Mar 2009 
Registration Price:
$249.00

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Reviews

Average Rating: (based on 4 reviews)

Showing 4 Reviews:

by S.F.
Clinical Project Manager
The information presented was clearly communicated and very informative.
by A.L.
Clinical Trials Associate
The slides we received were not numbered and it was hard at times to tell what slide the speaker was on.
by B.P.
Regulatory Affairs Project Manager
This conference was very much appreciated - very thoughtful ideas and representations of information. We will be speaking with PRA in the future and hope you will keep us on your webinar mailing list.
by L.L.
Clinical Trial Manager
This audio conference was very useful to understand the importance of a good feasibility.
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