Key Strategies You Must Know to SurviveIn today’s rapidly changing world of oncology clinical research

Denise DeakinPresident, Scimega Research

What’s Going On In Your Business?

Difficulty raising capital?

Problems staying within budget?

Operational Challenges?

What are others doing to succeed?

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

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”

The Promise of Personalized Medicine

Clinical Challenges in Oncology

More screening procedures

More specialized tests i.e. biomarkers

More regions & sites needed to access patients

Clinical Challenges in Oncology

Greater administrative burden

Increased competition for sites

Rising start-up costs

Clinical Challenges in Oncology

Protracted contract & CTA review

Longer studies = more patient visits

Shortage of CRAs with oncology expertise

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.

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

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?”

Reverse Feasibility™ Program

No Sponsor or Investigator FeesNo Sponsor or Investigator Fees

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

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

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

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

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

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

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

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