The Next Pandemic vs. Biopharmaceutical Industry
by Max Yaghchi — June 07, 2020
In December 2019, a spike in pneumonia cases marked the emergence of the novel Coronavirus (COVID-19), and the start of a global race for the development of treatments, vaccines, and diagnostic tools to combat the pandemic [1].
While COVID-19 has placed unprecedented burdens on global health systems and economies, lower respiratory tract infections (LRTI) like pneumonia have been a leading cause of early death since 1990 [2]. Moreover, the Global Burden of Disease Study projected that LRTI infections will continue to be the third highest global cause of early death in 2040.
In 2016, out of the top 10 leading causes of early death, 5 were due to infectious diseases (IDs): LRTI, Diarrheal Diseases, Malaria, HIV/AIDs, and Neonatal Encephalopathy [2]. The global burden of IDs has been historically composed of cases from the developing world, yet COVID-19 has demonstrated the susceptibility of all nations to IDs [3].
Registration of interventional therapies for IDs on ClinicalTrials.gov became mandatory in 2007, due to a legal requirement imposed by the FDA [3]. ID clinical trials have investigated vaccines, biologics, and drug therapies against pathogenic microorganisms, having comprised 8.5% of all clinical trials between 2007 and 2017. These trials were unique from others in that they tended to involve more participants and had greater international cooperation. However, within ID clinical trials, there is an underrepresentation of LRTIs. Despite accounting for 35.8% of global infection-related deaths, LRTIs comprise of only 6.6% of registered studies. Furthermore, ID trials were found to be more likely than non-ID trials to exclude patients over 65 years of age.
Trends identified in ID clinical trials between 2007 and 2017 (in Figure 2) demonstrate the role of market forces in driving pharmaceutical development [3]. Whenever a pandemic occurred, interventional therapies aimed towards that pathogen spiked in clinical trials. For example, during the 2007 H1N1 pandemic, there was a 64% increase in influenza vaccine studies, which persisted for 2 years. More recently, during the 2014–2016 Ebola epidemic in Western Africa, there was a 4.7-fold increase in clinical trials on hemorrhagic disease [3].
The COVID-19 pandemic has seen a sharp increase in interventional therapies entering clinical trials. As shown in Figure 3, a total of 924 studies were identified in May 2020, and most were in Phase II. While ID Phase II/III clinical trials typically average 3 years in duration, all COVID-19 trials, across all phases, targeted completion in 1.2 to 1.6 years. Across all phases, 46% of trials had started recruiting participants, while 41% had not. Any stall in recruitment may pose a barrier to the established timelines and tends to be the most reported issue for terminated ID studies.
Given the global impact of IDs and the small proportion of interventional therapies, improving ID clinical trial processes is crucial for advancing global health. Figure 4 illustrates data on the successes and failures of 10,000 ID clinical trials. The global completion rate for ID clinical trials was estimated at 68%, with Japan, UK, Germany, U.S., India, Spain, and Australia having the highest completion rates.
The leading reason for ID study termination was found to be recruitment challenges (30%), which occurred most frequently in Phase III of development. As ID innovations progressed through the clinical development phases, safety concerns became a less common reason for termination, but poor efficacy endpoints increased (14%). Biotech Square’s AI software is programmed to process clinical trial information, and to provide recommendations for study barriers including poor recruitment rates and inappropriate study design. By guiding sponsors through study design and implementation, the team hopes to increase the completion rates of ID clinical trials, and to bring new medical innovations to market without delay.
References
1. World Health Organization. Coronavirus. Retrieved May 22, 2020 from https://www.who.int/health-topics/coronavirus
2. Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017. Seattle, WA: IHME, 2018
3. Jaffe, I. S., Chiswell, K., Tsalik, E. L. (2019). A Decade On: Systematic Review of ClinicalTrials.gov Infectious Disease Trials, 2007–2017. Open Forum Infectious Diseases, 6(6).
4. New York Times. Coronavirus Map: Tracking the Global Outbreak. Retrieved, May 22, 2020 from https://www.nytimes.com/interactive/2020/world/coronavirus-maps.html
