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

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