Trends and Considerations in Global Infectious Disease Drug Dev | Page 9
Over a one-year period ending September 30, 2010, 78 companies
initiated 239 global Phase II and III infectious disease clinical trials.
During the same period, the largest number of new infectious disease
trial starts (52 percent) was for influenza vaccines for both seasonal
and pandemic influenza. Vaccine development in other diseases
was primarily for meningitis, HIV and HBV. 13
Over a one-year period ending
September 2010, 78 companies
initiated 239 global Phase II & III
infectious disease clinical trials.
Examples of potential medicines that would impact serious infectious
Investigative site selection for infectious diseases can present environmen-
diseases include two combined monoclonal antibodies that bind to, neu-
tal, logistical and timing challenges. Typically, sponsors must coordinate
tralize, and destroy toxins caused by Escherichia coli (E. coli) infections.
trials in many countries and work with many global regulatory authori-
Also in development are several drugs for the most common and difficult-
ties, increasing the timelines for complete data collection and review as
to-treat form of hepatitis C that inhibit the enzyme essential for viral
well as study expenditures. Logistics for the collection and timely analysis
replication, and an anti-malarial drug that has shown activity against
of laboratory specimens in different countries add to the costs. Coordina-
Plasmodium falciparum that is resistant to current treatments. Of 177
tion of couriers and labs is essential for maintaining viable laboratory
publicly reported infectious disease trials, 94 were testing vaccines, fol-
specimens crucial to supporting study endpoints.
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lowed by HIV at 24 and hepatitis C virus (HCV) at 23. Most vaccines were
for various respiratory infections (51 of 94), with the majority evaluating
Certain diseases, such as seasonal influenza and malaria, require testing
influenza vaccines (38), equally split between seasonal and swine influ-
during a specific season or environment. A seasonal influenza trial might
enza.14 Current therapeutic areas of development focus include hepatitis
take place in the US from late fall through March, and then continue in
C, which has a patient population of nearly four million in the US15; lower
Australia during their fall-winter season. Patient lifestyle may also dictate
respiratory tract and skin infections; and suppressive, palliative and cura-
site location. For acute bacterial exacerbation of chronic bronchitis,
tive therapy for certain viral or other infections in immunocompromised
trials may require countries where smoking is prevalent, such as Russia.
patients. For both seasonal and pandemic influenza, there is an urgent
For others, sites are selected wherever the disease emerges. Infectious
need for new antibiotics.
diseases can appear and diminish in a population quickly, so preparation
and planning is critical. Sponsors seeking favorable trial venues must
Challenges in Infectious Disease Clinical Trials
also consider access to treatment-naïve patient populations; regulatory
Escalating development costs, regulations, and trial complexity along
environments regarding ICH-GCP standards; the availability of experi-
with the many issues involved in infectious disease development have led
enced investigators; and clinical trial operations, including the availability
to the decline in innovation. Regulatory trends driven by increasing safe-
of technology platforms and resources such as centralized laboratory ser-
ty requirements and more rigorous definitions of study endpoints have
vices capable of performing study-specific tests using validated technology.
led to larger, longer, and more complex and costly global trials with increased pressure to efficiently recruit the targeted subjects.
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