pra revs up multiple myeloma study
Post on 16-Oct-2021
2 Views
Preview:
TRANSCRIPT
CASE STUDY
PRA Revs Up Multiple Myeloma StudyHow We Exceeded Timelines for Site Activation & First Patient In
PRA Revs Up Multiple Myeloma StudyHow We Exceeded Timelines for Site Activation & First Patient In
Primary Endpoint Safety and efficacy
PRA Services Full service
Indication Multiple Myeloma
Drug Class Thalidomide Analogues
Study Phase III
Business Segment Product Registration
Regions North America Western Europe Central Europe Eastern Europe Asia Pacific
STUDY DESCRIPTION
Study 1: A Phase III, multi-center, randomized, open-label study to compare the efficacy and safety of Study Drug A in combination with low-dose Study Drug B versus high-dose Study Drug B in patients with refractory or relapsed and refractory multiple myeloma.
Study 2: Open-label, single-arm study to evaluate the safety and efficacy of Study Drug A monotherapy for patients with refractory or relapsed and refractory multiple myeloma, a companion study for Study 1 above.
A large biotech company selected PRA to conduct 2 global Phase III open-label studies to measure
the safety and efficacy of a multiple myeloma drug. The studies presented a number of critical
challenges to the PRA project team, including the client’s requests that we activate sites earlier than
projected and increase the enrollment rate. The challenge of accelerating site activation was further
exacerbated by the following delays:
• Principal investigator changes at sites, vacation periods, and delays in Clinical Trial Application (CTA) submissions.
• The client put the Ministry of Health (MoH) resubmission on hold in Sweden.
Situation & Challenges
Study Duration Study 1: 35 months Study 2: 29 weeks
No. of Clinical Sites 91
Treatment PeriodStudy 1: 15 months Study 2: 15-60 months
Patient Population 426
PRA Health Sciences conducts comprehensive Phase I-IV biopharmaceutical drug development. To learn more about our solutions, please visit us at prahs.com or email us at prahealthsciences@prahs.com.© PRAHS 2019. All rights reserved.
The PRA team’s strategy and persistence resulted in successful site activations and first patient in (FPI), as illustrated in Figure 1. Study metrics included:
• First site activated only 3 months after “start” with core documents in place and contracting sites
• First patient randomized approximately 2 weeks earlier than projected, exceeding the client’s standard timelines by 4 months
• Site activation dates achieved about 4 months earlier than projected in 7 out of 15 countries: Spain, France, Belgium, Germany, Italy, Greece, and Australia
• Due to these metrics as well as PRA’s response to the study’s daunting study challenges, the client selected PRA as a preferred provider for a full-service, Phase I-IV contract
Results
Figure1: Site activation and FPI
MA
R2016
Through teamwork and strategic planning, PRA developed the following effective plans that helped us reach the client’s milestones for both CTA and MoH/Informed Consent Form (ICF) submissions:
• CTAs: The team conducted consistent follow-up with sites and coordinated with client affiliates to expedite signature process at sites.
• MoH/ICFs: PRA collaborated with the client‘s Regulatory Affairs team in Europe to develop a comprehensive strategy to achieve Central Ethics Committee (CEC)/MoH approvals ahead of projected timelines.
Solutions
100
200
300
400
500
600
0.62
Mar11
May11
Jul11
Sep11
Nov11
Jan12
Mar12
May12
Jul12
Sep12
actual
0.3
top related