Ebola, still without a cure, has recently claimed more than 450 West African lives and continues to spread, according to the World Health Organization. Infectious diseases like Ebola are not a thing of the past. In fact, today, they cause 1 in 4 deaths worldwide among children under age five, even with advancements in medicine and technology.

This staggering ratio exists because bacteria and microbes have the potential to evolve and become resistant to certain drugs and treatments that previously eradicated them. Clinical infections have three parts: the antimicrobial drug, the pathogen that is either susceptible or resistant to treatments, and the host’s immune response. This means that while new infectious diseases continue to emerge, old infectious diseases will also re-emerge, creating a never-ending cycle of diseases. Our series,Trends and Considerations in Global Infectious Disease Drug Development, discusses the evolution of antimicrobial drug development, the uniqueness of antimicrobial trials, current challenges to successful drug development, and opportunities in the evaluation of new agents impacting this unique therapeutic area.

In the past, infectious disease drug development occurred in response to a crisis or issue. As the threat of bioterrorism grows, the fear of pathogens such as smallpox, anthrax, and tularemia also rises due to their potential use as agents. It is imperative clinical studies are done now to prevent mass casualties, but it is also important to develop drugs for the less deadly infectious diseases that can spread across populations, like the influenza virus. This infection, during a typical year in the US, causes 30,000 to 50,000 deaths; other years, the numbers are even higher such as the influenza pandemic in 2009.

Unfortunately, clinical studies of drugs for infectious diseases face many difficulties. Diagnosis of a disease often takes several days to process in the laboratory, but patients must be enrolled in a study within 12-24 hours. Patients must also have no concomitant or prior use of antimicrobials—severely limiting the pool in the United States. Some diseases, like influenza and malaria, also necessitate certain seasons or environments, and can appear and disappear in populations quickly. This sporadic appearance requires fast and efficient planning as well as upkeep with the drugs because some diseases mutate at the end of their season rendering the drug useless. Thankfully, since their introduction in the 1930s, infectious disease drugs have had a large impact on patient morbidity and mortality.

Despite the obstacles, 2010 had 395 medicines and vaccines in the US in trial stages or in review by the FDA. The future will probably focus on improved antibacterial and antiviral combination therapies and more narrow-spectrum drugs against infectious agents, which will be less likely to lead to multidrug resistance.

While thankful for advances, there is still a need for therapeutic innovation, prompt and efficient diagnoses, and constant surveillance to compete with the growing threat.


Clinipace aims to provide a wealth of knowledge to clients and potential clients through the production of eBooks, webcasts, and infographics found under the various sections of the Resources tab. The tab has been redesigned for easier navigation to make our information more available to you. Read our Trends and Considerations eBook, listen to our Webcast, or check out our infographic to learn more about the difficulties faced during clinical trials of infectious disease drugs as well as advances in technology and other considerations.