key strategies to survive in today\’s changing world of oncology clinical trials
DESCRIPTION
This overview highlights the most critical issues affecting oncology clinical development in the U.S. biopharmaceutical industry To view the full webcast with audio please visit http:/www.scimega.com/resources-oncology-webcasts.phpTRANSCRIPT
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Key Strategies You Must Know to SurviveIn today’s rapidly changing world of oncology clinical research
Denise DeakinPresident, Scimega Research
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What’s Going On In Your Business?
Difficulty raising capital?
Problems staying within budget?
Operational Challenges?
What are others doing to succeed?
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New Cancer Cases Each Year
Over 50% survive > 5 years *
*American Cancer Society*American Cancer Society
0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000
2009 2020
New Cases
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Cost of Ineffective Medicine
Cancer Drugs that have no effect on the patient
1 Jane Theaker, Jennifer Lewis and Marc Egelhofer (November 2010) “Personalized Healthcare: From Vision To Reality”
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The Promise of Personalized Medicine
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Clinical Challenges in Oncology
More screening procedures
More specialized tests i.e. biomarkers
More regions & sites needed to access patients
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Clinical Challenges in Oncology
Greater administrative burden
Increased competition for sites
Rising start-up costs
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Clinical Challenges in Oncology
Protracted contract & CTA review
Longer studies = more patient visits
Shortage of CRAs with oncology expertise
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Early Phase Clinical Challenges
30% of sites are inactive ($16-20K per site)
Need to identify specific patient populations
Examine opportunities outside the U.S.
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Traditional Site Feasibility Process
• Incomplete study & budget info• Not getting specific enrollment projections• Not allowing time for proper assessment• Requesting Free feasibility assessments
• Not leveraging investigator database• Not explaining site selection criteria
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The Patient Recruitment Challenge
Less than 50% of trials meet enrollment targets
$40,000 for each day a site is open
*Applied Clinical Trials, July 1, 2008 “Is Investigative Site Feasibility Feasible?”
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Reverse Feasibility™ Program
No Sponsor or Investigator FeesNo Sponsor or Investigator Fees
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Investigative Site Information
• Pertinent experience • Capacity• Equipment• Catchment area
• Genotyping capabilities• IRB requirements/schedule• Start-up fees• SOC – availability and reimbursement• Recruitment openings over next 6 months
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How can you be one of the success stories?
2.2. Partner with niche service Partner with niche service providers & sitesproviders & sites
3.3. Rethink the traditional site Rethink the traditional site feasibility processfeasibility process
4.4. Embrace change & turn Embrace change & turn obstacles into opportunitiesobstacles into opportunities
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Success Story
Challenge: • Concern about recruiting enough U.S. pts.• Rare solid tumor dose-ranging Phase I/II study
Situation: • Trial ongoing for 14 months in U.S.
• Need to mitigate potential recruitment risk
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Success Story
Site 1:Site 1: Major teaching institutionMajor teaching institution
Study start-up:Study start-up: 2.5 months 2.5 months ((protocol receipt to 1st patient inprotocol receipt to 1st patient in))
IRB:IRB: 2 months2 months
FPI:FPI: 9 days post initiation visit9 days post initiation visit
Pt. enrollment:Pt. enrollment: target = 3pts/12 monthstarget = 3pts/12 months
actual = 3 pts/5 monthsactual = 3 pts/5 months
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Success Story
Site 2:Site 2: Major teaching institutionMajor teaching institution
Study start-up:Study start-up: 3.5 months 3.5 months (protocol receipt to 1st patient in)
IRB:IRB: 3 months3 months
FPI:FPI: 27 days post initiation visit27 days post initiation visit
Pt. enrollment:Pt. enrollment: target = 3 pts/12 monthstarget = 3 pts/12 monthsactual = 3 pts/4 monthsactual = 3 pts/4 months
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Value of The Reverse Feasibility™ Program
“It worked great for us. We’re happy to have found a couple fantastic sites that have been very helpful in meeting our aggressive enrollment timelines.”
- Director of Clinical Operations
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Make Better Strategic Decisions Faster
To view the full webcast with audio To view the full webcast with audio please visitplease visit
Oncology WebcastOncology Webcast
www.scimega.comwww.scimega.com