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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