Payment Practices, FMV, and Study Performance - Harold Glass

January 11, 2011, Philadelphia, PA

Payment Practices, Fair Market Value, and Study Performance: EbyDA

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Harold E. Glass, Ph.D. USciences & TTC, LLC

• In such a complex, costly, activity as drug development, we must move beyond explanation by dominant anecdote and look at evidence. • Paying more doesn’t improve study performance,

but may raise questions for regulators.• Certain CROs and sites get paid more: why,

because they can.• Other elements than payment levels appear to

explain study performance.

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Major Themes

A Different Business

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• What do Tide, Coke, Harley Davidson, Ivory Soap, etc. have in common?

• What did they have in common in 1938?

• The pharmaceutical business model is very different

• Name four current market leading drugs from 1938, 1958, 1988?

CRO Pricing

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• CRO pricing is much more directly market based than investigator grant pricing, especially if you can compare apples to apples.

• However, investigator grants amounts are also largely market based.

CRO Performance

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• It makes little difference in study completion times whether a CRO or sponsor company does the work.

• Any analysis like this must control for ZANZIBAR, e.g., countries involved, indications, priority, number of visits, number of patients and sites, phases and the like.

• We are conducting this research now on 2,355 phase 2 and 3,121 phase 3 studies, using data from sources such as the Center for Medicines Research (CMR), examining six steps in the clinical trial process:

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CRO Performance

FMV and Study Drug Prescribing

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• Investigators subsequently prescribe more study drug, Investigators subsequently prescribe more study drug, although the amount of the grant has no effect.although the amount of the grant has no effect.

Phase III Average Product Market Share of Drug ClassPhase III Average Product Market Share of Drug Class

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5

10

15

20

25

30

3 months 6 months 18 months

Control

Investigator%

Survey Methodology

• We have recently completed a global 4,000 site survey of investigator attitudes including:

• Why they participate in clinical research,

• What they like and dislike about clinical research,

• Which companies and CROs are good at running clinical trials.

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Reasons for Participating in a Clinical Trial

FACTOR ITEMS

Medical Innovation

Financial Considerations

Study Sponsor and Conduct

Watch This Space

• Using a number of proprietary and public databases we are looking at what factors are associated with faster completion times:

• We know payment levels are not. • Other areas might, including,

• the nature of the organization running the study

• Study design• Site selection

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Organizational

• No difference between sponsor company and CRO run studies for field work.

• Larger companies are distinctly slower. Larger companies pay more, except in Latin America.

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Number of Countries & Study Completion

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• More countries means more time

y = 18.597x + 489.84

R² = 0.359

Site Performance

• Site staffing and workload are clearly related to performance, across all types of sites and geographies.

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