1. No category

CASE STUDY
P R A H E A LT H S C I E N C E S
P RA DE L I V E RS STUDY START-U P SUCCE SS
Contingency Plan Leads to Timely FPI
P R A H E A LT H S C I E N C E S C A S E S T U D Y
P R A D E L I V E RS ST U DY START-UP SUCCE SS
Contingency Plan Leads to Timely FPI
S T UD Y D E S C RIPTIO N
A Phase IIa randomized double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of
of Study Drug when given Methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) who have had an
inadequate response to conventional disease-modifying anti-rheumatic drug therapy (DMARD).
S T U D Y D UR ATI O N
N o . O F C LI N I C A L S I T E S
24
28
MONTHS
P RIM ARY E NDPO INT
To evaluate the clinical
efficacy of the Study Drug
with MTX in subjects with
active RA who have had an
inadequate response to
DMARD therapy
P AT I E N T POPULATION
R EG IO NS
150
T RE AT M E N T P E RI O D
3
MONTHS
adults with active
rheumatoid arthritis
150
North America
Central & Eastern Europe
adults with active
Asia Pacific (Incl.
India) arthritis
rheumatoid
P RA S E RVICES
Full Service
IN D ICAT ION
Rheumatoid Arthritis
D RUG CL AS S
Small Molecule
S T UD Y P H ASE
Phase IIa
BUS IN E S S SEG MENT
Product Registration
SI T UAT I O N
After an impressive bid defense, a major PRA client awarded a rheumatoid arthritis study contract based on
our strategy for achieving first-patient-in (FPI) by the end of the calendar year. PRA’s plan depended on a closely
managed project with clear timelines and responsibilities, as well as selecting key sites that could support our goal.
CH A L L E NG E S
During the ethics committee (EC) submission process, last-minute revisions to the subject questionnaire and a
protocol amendment caused PRA to miss the established EC milestone. In addition, PRA would have to screen
patients during the December holiday season, and there were delays with the investigational product/supply shipments.
THE FUTURE OF CLINICAL DEVELOPMENT.
P R A H E A LT H S C I E N C E S C A S E S T U D Y
SO LU TI O N S
PRA and the client recognized the need to address study start-up delays. The PRA team collaborated to develop an
innovative and efficient contingency plan, which involved activating 4 new central institutional review board (IRB)
sites in Canada and targeting Ministry of Health (MoH) approval in November. Although the FPI goal was escalated
to “at risk” status in November, we continued to proactively identify and manage all risks while maintaining continual communication with the client through weekly project start-up summary reports.
R E S U LTS
Despite numerous study start-up delays and challenges, PRA reduced the project’s cost by approximately 15%
through our ability to enroll the targeted number of patients with fewer sites and in a shorter time period. In addition, we met the client’s corporate FPI goal, randomizing the first subject on the fifth month. PRA and this client are
now in a successful strategic partnership with a relationship focused on absolute transparency, frequent communication, and clear responsibilities and expectations.
M ON TH 1
M ONTH 2
• Letter of Intent
Signed
• Final Feasability
Report
• Initial Protocol/Final
Investigators
• Client/PRA Kick-off
Meeting
• Brochure
• Selection of 2 FPI
Countries
(AUS & CAN)
MONTH 3
MONTH 4
MONTH 5
• Protocol Version 3
• First Site Activated
• SIVs (AUS & CAN)
• EC/MoH Review
(AUS & CAN)
• MoH Approval
(AUS)
• First Patient Screened
• MoH Approval
(CAN)
• First Patient Randomized
• EC Approvals
(AUS & CAN)
• Submission of
Protocol Version 2
in Australia
Despite unexpected study delays and challenges, PRA met the client’s FPI goal by:
• Developing an effective contingency plan.
• Proactively identifying and managing risks to the client’s goal.
• Maintaining excellent communication with the client’s project team.
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 [email protected].
THE FUTURE OF CLINICAL DEVELOPMENT.
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