Study Start-Up

Expert Meeting on Site Metrics for Study Start-Up

MAY 04, 2010

CTTI Project: Study Start-Up

Meeting Background:

The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify core data elements that should be collected by all clinical trial sites to allow measurement and improvement of important timeframes for study start-up.

Meeting Objectives:

  • Review the results from retrospective analysis to describe the current state of study start-up at sites participating in multicenter clinical trials
  • Review, discuss and agree on a proposed list of standard metrics for site start-up activities including a standard, specific, and measurable definition for each metric that will be utilized in a prospective data collection pilot coordinated by CTTI
  • Discuss strategies for success and potential barriers for engaging sites to participate in the prospective data collection pilot that will be designed to facilitate and encourage sites to measure themselves against “sites like me” to identify opportunities for improving their internal processes and cycle times

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentations:

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

CTTI Report Finds Contracting and Budgeting are Significant Pain Points for Study Start-Up

Posted on by Hannah Faulkner

It’s no secret that the entire clinical trials ecosystem is affected by painfully slow study start-up timelines. CTTI recently sought to investigate the factors that influence this crucial problem. After conducting a literature scan, in-depth conversations with sites and sponsor groups, and a working group meeting, CTTI released a report showing that budgets and contracts are significant contributors to delays.

During exploratory conversations, CTTI repeatedly heard from stakeholders that several process, infrastructure, and motivational factors influence timely budget and contract negotiations:

  • The language in clinical trial contracts or clinical trial agreements (CTAs) varies considerably among sponsors and may be subject to interpretation. Indemnification, intellectual property, publication rights, subject injury, and confidentiality continue to be contentious topics, often delaying timelines in order to reach an agreement.
  • Further complicating the issue is the variability of infrastructure and resources among organizations. Limited or inexperienced staff, personnel turnover and/or the lack of investment in streamlining technology can influence the efficiency of the process.
  • Motivational factors may also influence budget and contract negotiation timelines. For example, having a key opinion leader in a trial or participating in a blockbuster trial are potential motivators.
  • Sites often reported feeling underpaid for their time and resources, while sponsors noted unintended administrative costs, site overhead fees and/or additional expenses outside the intended protocol budget.

Based on the findings, the working group determined that streamlining clinical trial budgets would be more feasible and have a greater potential impact than streamlining contracts. Three potential areas for improvement include infrastructure and resource needs, communication and transparency, and budget review and negotiation methods.

CTTI hopes the findings from this initial research will spur further conversation on improving budget and contract processes in study start-up and motivate others to continue the search for sustainable solutions. Read the full report.