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2021 年 6 月 7 日

Driving Site Engagement in Medical Imaging Trials

Many clinical trials depend on high-quality medical imaging — and high-quality imaging very much depends on engaged investigative site staff.

Sponsors and CROs can help to ensure trial success by remembering that while imaging is often key to demonstrating efficacy, investigative site personnel don’t always have time, amidst busy schedules and miles of paperwork, to implement confusing and manual processes. Therefore, study planning should incorporate as many tools as possible to ease site staff burden and keep them engaged throughout clinical trials.

Here we explore how central medical imaging can improve sites’ overall experience, how processes designed to support sites ultimately benefit all trial participants, and how by reducing burden with fewer manual processes, site staff can spend more time with patients, get patients on therapy sooner and deliver results to sponsors faster.

Introduction

Over the past three decades, medical imaging has become an integral part of the drug development process for biopharmaceutical companies. Clinical researchers and patients welcome medical imaging-based techniques because they facilitate non-invasive screening methods for study recruitment and can detect disease, monitor outcomes, and predict therapy response.1 As more medical imaging biomarkers are identified and validated, the number of clinical trials that use imaging is expected to grow..2

Sponsors often require specialized expertise from an imaging core lab to design and implement medical imaging in their trials. This is especially true in large, multi-site, global trials where data standardization, regulatory compliance, and assurance of consistent quality across all sites, subjects, and time points are essential for the successful evaluation of a therapeutic drug or medical device.

As imaging becomes more common in trials and is being requested earlier in development due to accelerated approvals, the demands on study coordinators and radiology staff will continue to increase. Thus, it is essential that the requirements for sites are simple and clear and that studies are designed with the sites’ needs clearly defined upfront.

“An imaging core lab’s investment in technological and operational upgrades removes labor-intensive processes, leaving site staff more time to focus on what matters most — patient care and data quality”

– Elizabeth Dalton, VP, Technical Solutions, Calyx

Improving the Site’s Imaging Experience

By working with a reliable central imaging provider with tech-enabled services, sponsors and CROs can improve the site experience by:

  • Accelerating the qualification of sites and study start-up
  • Fostering site engagement through customized scientific training for radiology facilities
  • Providing medical imaging-based eligibility status faster
  • Improving data collection and quickly supporting real-time safety and efficacy feedback to sites
  • Maximizing data security (e.g. HIPAA, HGRAC, and EU Data Protection Directive compliance)
  • Enabling proactive query management through:
    • Prompt, clear communication of deviations and corresponding resolution requirements
    • Quick action on site query responses
    • Query prioritization and responses for eligibility, rescan requests, progressive disease, etc.
    • Accurate and comprehensive query reports
  • Increasing transparency through improved reporting
  • Supporting multiple imaging centers within a given trial to enable decentralized trials

Conclusion

Improving the site experience helps achieve more rapid site onboarding and patient enrollment, improved data submission, better communication with sites, and quicker query resolutions. The benefits ultimately lead to faster decision-making and higher quality study completion which saves study sponsors valuable time, effort, and money.

A central medical imaging partner can help to keep site personnel engaged in clinical trials by leveraging expertise, processes, and technology that simplifies day-to-day tasks; allowing these critical stakeholders to return their focus to what matters – their patients and helping to support drug approval.

References

  1. http://media.jamanetwork.com/news-item/substantial-increase-in-rate-ofadvanced-diagnostic-imaging-associated-radiation-exposure/
  2. http://media.jamanetwork.com/news-item/substantial-increase-in-rate-ofadvanced-diagnostic-imaging-associated-radiation-exposure/

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