Trends and Considerations in Global Infectious Disease Drug Dev | Page 10

Enrollment Complexities
Enriching the trial patient population is an important recruitment trend, but

Figure 8. Additional

Challenges
to Successful Development

infectious disease diagnosis can be difficult. For each type of influenza (swine,
avian, seasonal, etc.), for example, investigators must identify not only the type
of influenza but also predominant strain, the affected population, and location
of the disease outbreak. For community-acquired diseases such as pneumonia,
rapid diagnosis is possible, but investigators must determine the strain, whether
the patient has a resistant infection, and the etiology -- whether the disease is
from a virus, bacterium or fungus—and provide rapid treatment. For conditions
such as seasonal influenza, they need to know when the disease will present,
peak and diminish in a community, allowing a finite time for patient enrollment. When influenza presents in a community, the virus may only circulate
for six to eight weeks. Since some infectious disease pathogens mutate, such
as those for dengue fever, which mutate at the end of their season, investigators must remain on alert for new outbreaks. Clinical trials in acute infectious
diseases need new efficiencies, which can be facilitated by rapid diagnostics
and clinical trial management systems that provide immediate access to blinded
data that allow ongoing assessment and adjustments to ensure the correct
patie