Development Times and Approval Success Rates for Drugs to Treat Infectious Diseases

Abstract

We gathered data from three pipeline databases and other public sources on development stage and clinical trial metrics for 1,914 investigational drugs, biologics, and vaccines and 2,769 clinical trials intended to treat a wide variety of infectious diseases. We included new molecular entities (NMEs), new formulations, and new combinations. Clinical trial times decreased from 2000–2008 to 2009–2017, varied by disease class, and were longer for trials with more subjects or more sites. Clinical approval success rates were higher for this set of diseases than those in the published literature for drugs across all therapeutic categories. NMEs to treat HIV had a success rate (16.0%) that was similar to those for drugs in general, whereas NME success rates for influenza and pneumonia were much higher (48.1% and 50.5%, respectively).

Eyes on New Product Development

“…The challenges in developing novel treatment for infectious diseases (including antibiotics and antivirals) from scientific, regulatory, and business perspectives continue to be debated (December and January 2020). 6 The practice of dispensing 90 days of medication, efficient for health care delivery, was questioned for patients with depressive disorders, as it may provide them an easily available method to commit suicide. 7 There is a growing realization that sponsors of clinical trials are not complying with the law regarding posting of results on clinicaltrials.gov.…”

Clinical Pharmacology and Therapeutics: 2020 in Review

“…Little did I know how the world would change when I wrote the editorial on finding new drugs for infectious diseases for the February 2020 issue, 15 inspired by the analyses from DiMasi et al at Tufts University. 16 My pre-coronavirus disease 2019 (COVID-19) conclusion was that "If anything, the analysis by DiMasi and colleagues underscores that from a scientific and clinical perspective drug development in infectious diseases should be relatively successful. Clinical pharmacologists should be at the forefront of converting this opportunity into reality through application of existing and emerging innovative drug development paradigms in the context of global health."…”

“…As a reminder, DiMasi et al found that current clinical trial times for infectious diseases range from 2-8 years. 15,16 The journal experienced an unprecedented number of submissions related to COVID-19 and we are grateful and indebted to the large number of members of our Editorial Board and peer reviewers who have been instrumental in helping us select the most impactful science and maintaining the highest standards in a rapidly moving environment. 18 We look forward to working with them, our authors, readers, and many others to continue to fulfil CPT's mission to be the leading journal for clinical pharmacology and therapeutic innovations, transforming the development and utilization of medicines across all diseases for all patients.…”

“…As a reminder, DiMasi et al . found that current clinical trial times for infectious diseases range from 2–8 years 15,16 …”

Rapidin silicodesign of antibodies targeting SARS-CoV-2 using machine learning and supercomputing

“…Traditional drug and biologic development are experiment-driven, typically executed via large-scale screening in vitro and in vivo. While traditional approaches have led to many effective and safe therapeutics, they require years to complete and therefore cannot alone be relied upon to support a rapid response to novel pathogens [5][6][7].…”