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Multiple Myeloma

PHASE 3

Case Studies

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Key Takeaways

To randomize 900 patients for two global research studies investigating potential new therapies for multiple myeloma, BBK Worldwide established a strategy for sites in an enrollment plateau after first-patient-in to determine site feasibility and ensure the research study would enroll on time.

 

This helped the contract research organization and sponsor identify which sites to keep open and to close, ultimately leading to increased enrollment rates.

Multiple Myeloma

 

Challenges 

 

  • A narrow patient pool among diverse patient cultures
  • Restrictive inclusion criteria
  • Numerous competing research studies that made for a crowded clinical trial landscape
  • Uncomfortable study drug side effects and the potential for placebo
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Solutions 

BBK Worldwide stepped in again during the study when patients began experiencing nausea and other side effects from the study drug. Setting up a web forum, BBK enabled clinicians to post messages that a sponsor representative reviewed and published.

Specifically, the forum was set up to help nurses outside the United States who were less comfortable with the active comparator to ask questions to nurses in the United States, in a controlled manner.

 

Impact

BBK Worldwide facilitated intensive strategic support using a culturally adapted patient recruitment kit, a clinician forum and other resources implemented globally to help enroll the study on time.

The clinician forum helped ensure compliance with study procedures and preserved data integrity.

 

  • Participants_ICON 900 ENROLLED PATIENTS

  • Sites_ICON 350 SITES

  • Countries-ICON-1 32 COUNTRIES

  • Calendar_ICON 18 MONTHS OF SUPPORT

 

 

 

 

 

 

 

 

 

 

 

 

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