Today, despite remarkable advances in medical research and treatments, infectious diseases remain a very serious threat, causing about one in four deaths worldwide, including approximately two-thirds of all deaths among children younger than age five. Over the past several decades, it has become apparent that new infectious diseases will emerge, older threats will re-emerge, and microbes are increasingly prone to outsmart efforts to contain or eradicate them.
The development of treatments for infectious disease poses unique challenges, including resistant bacteria and viruses, enrollment complexities and waning investigator interest. We can help you navigate those challenges, and create opportunities in the evaluation of new agents impacting this unique therapeutic area.
Let our Regulatory and Strategic Development (RSD) experts provide their expertise on the numerous new guidelines issued by the FDA for antimicrobial drug clinical trials, such as requirements for better defined patient populations and microbiologic identification of pathogens, superiority studies required for approvals, redefining of clinical endpoints and others.
With increased Government and private support, the outlook for this unique, often devastating disease class is brighter than ever. With the advent of rapid diagnostic tests, advanced technologies such as integrated eClinical platforms and other future development opportunities creating a more robust research pipeline, we can all work together to help meet the continuing, ever-changing global threat from infectious disease.