Download Capabilities in Infectious Disease Studies

Capabilities in Infectious Disease Studies
Expertise in
Infectious Disease
Clinical Trials
Experience of Health
Decisions and our clinical
leadership, PMs and
CRAs includes trials in all
phases and the following
indications in infectious
disease:
• Bacteremia
• Chlamydia and
gonorrhea
• Clostridium difficile
• Hepatitis C
• HIV
• Influenza
• MRSA
• Respiratory viruses
• Sepsis
• Skin and soft tissue
Infection
Health Decisions has extensive experience with infectious disease clinical trials, including
studies of therapeutic agents, prophylactics and diagnostics. Our successful studies involve
a variety of indications, including MRSA, hepatitis C, Clostridium difficile and HIV. Health
Decisions’ global capabilities include rapidly adapting enrollment strategy based on
prevalence and seasonality of infectious diseases in different regions.
Health Decisions’ Award-Winning Technology,
Insight and Expertise
Health Decisions’ operational excellence based on “agile” datadriven techniques has been recognized by a variety of awards
from independent publications and organizations. Agile Risk-Based
Monitoring+ won the prestigious 2013 CIO 100 award for technology
delivering true business value. Agile RBM+ is consistent with FDA and
EMA guidance on risk-based monitoring but goes far beyond, delivering
exceptional value as well as ensuring data quality and patient safety.
Health Decisions received the 2014 Award for Innovation in Clinical
Research from the Association of Clinical Research Professionals,
affirming our record of innovation. Health Decisions’ senior professionals
draw on extensive experience and data-driven analytics to provide
insights that improve planning and execution of every Health Decisions
study. Health Decisions’ experts also advise and consult on overall
development strategy, program planning and study design.
2014 ACRP Award
Innovation in
Clinical Research
Case Study: Acute Bacterial Skin and Skin Structure Infections
Predictive Probability of Efficacy of Therapeutic Agent X Administered for 10–14 days for the Treatment of ABSSSI, including
S. aureus (MSSA),MRSA, and Streptococci.
Phase: 2
Active Sites: 17
Patients Enrolled: 194
Treatment Duration: 10-14 days
Patient Population: Adults age 18 to 65 years
with gram-positive ABSSSI, including MSSA, MRSA
and streptococci
Study Design: Randomized, double-blind,
dose selection study for novel antibacterial utilizing
Bayesian predictive probability
Challenges Faced:
• The need to obtain a clear signal from a cost-effective
sample-size in phase 2 before advancing to phase 3
• Difficulties in defining such a signal because of uncertainty
about noninferiority margin and confounding factors
such as comorbidities and concomitant medications to
treat pathogens in addition to those targeted by the
investigational drug
• Evolving endpoints in such studies, with a shift from a
fixed time point such as 28-day mortality to cessation of
spread and absence of fever at 48-72 hours, sustained at
10-14 days
• Inconsistency in assessment based on variability of
investigator observations of patient status
Risk Management and Mitigation: Health Decisions worked
with the sponsor to design an adaptive trial and define a
clear signal for proceeding to phase 3. The phase 2 design
utilized Bayesian techniques to test three dosing levels of
the investigational drug against an active control, to analyze
accumulating data to project success for each arm and to
determine whether to proceed to phase 3 based on projected
likelihood of success. Because the test drug was expensive
to manufacture, the decision to proceed to phase 3 required
a high probability of success. The design assumed that the
primary endpoint for the phase 3 trial would be 28-day
mortality and assumed a phase 3 sample size of 2200 divided
between the test drug and the comparator. Projections of the
likelihood of phase 3 success were based on having a power
of 95% to detect a reduction in 28-day mortality from 40% to
30%. The design also specified stopping early for futility if the
posterior probability of such a reduction in 28-day mortality
was less than 50%. A recommendation to proceed to phase
3 depended on observing a 70% predictive probability of
demonstrating such a reduction. Based on determination of
such a predictive probability, the sponsor proceeded to phase
3 development.
The CRO of Choice for Forward-Looking Biopharma and Medical-Device Companies
Health Decisions is the CRO of choice for forward-looking biopharma and medical-device companies
and a driving force in the modernization of clinical development. Health Decisions uses data-driven
insight and agility to deliver clinical development success, reduce timelines and risk and increase
quality and returns for biopharma and device companies worldwide. For 25 years and in more than
300 clinical trials involving tens of thousands of patients in many therapeutic areas, Health Decisions
has improved the efficiency of clinical development through innovative methodology, processes
and technology. Health Decisions’ clinical-development services have enabled biopharma and
device companies to bring new products to market faster and at lower cost, thus providing the public with earlier access to improved treatments
and diagnostics at more affordable prices. Health Decisions received the 2014 ACRP Award for Innovation in Clinical Research and was a 2013
CIO 100 Award Honoree for delivering true business value through its innovative Agile Risk-Based Monitoring+ technology. Health Decisions is
headquartered in Durham, NC and operates on five continents.
Health Decisions 2510 Meridian Pkwy. Durham, NC 27713
Tel: +1.919.967.1111 Toll Free: +1.888.779.3771 Email: [email protected]
©2014 Health Decisions. All rights reserved. All brand names are trademarks or registered
trademarks of their respective company.