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Assessing unit-price adjustments in long-running trials

Providers may request fee adjustments during a long-running trial.

Representative research photograph: Assessing unit-price adjustments in long-running trials
Photo: The U.S. Food and Drug Administration · License: Public domain · Cropped and resized.
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Providers may request fee adjustments during a long-running trial. A single proposed percentage can obscure which services are affected. Sponsors should assess the existing scope, the contractual mechanism and continuity of necessary services together rather than treating a price request as an isolated financial exercise.

Decision framework

Ask which period and cost categories the proposal concerns. Contract owners should verify whether fees are fixed or linked to an adjustment mechanism. Separate higher unit prices from increased activity volume. Do not automatically assume that a future adjustment also changes charges for work already completed in an earlier period.

Worked example

For example, a supplier requests a general increase covering both external laboratory costs and its own project-management fees. The team separates the mechanisms and prevents the same item being adjusted twice. A revised forecast does not itself determine whether the underlying service remains scientifically necessary for the trial.

Implementation checks

  • Map the request to the relevant fee line, effective date and applicable provision in the agreement.
  • Explain the effects of future work volume and revised unit price separately before combining them in the forecast.
  • Make a visible, authorised continuity plan for critical services while commercial discussions remain unresolved between the parties.

Acceptance and boundaries

Accept the assessment when price effects can be distinguished from scope growth and both parties know the applicable fee version. This example recommends no particular increase. Refer tax, legal and purchasing matters to appropriate specialists, and do not reduce quality or participant-protection activities merely because financial pressure has increased.

Frequently asked questions

Does inflation automatically raise every fee?
No. The applicable agreement and authorised assessment determine the position.
Should a new rate be applied to the whole budget?
Explain affected periods and line items instead of making an unsupported generalisation.

Sources

  1. EMA — ICH E6 good clinical practice
  2. WHO — Guidance for best practices for clinical trials