Don’t Let A Crisis Go To Waste: Join Our Clinical Trials Recruitment Hackathon
Upcoming Hack Gives You A Crack At COVID-19
In 1976, the journal Medical Economics published an article by M. F. Weiner titled “Don’t Waste a Crisis — Your Patient’s or Your Own.” Although the thought, expressed in various ways, has surfaced elsewhere since, attributing its origin to the medical context seems appropriate. The crisis of the hour is COVID-19 — we here propose one way of using it as a positive call to action.
On March 28, there will be a hackathon at Columbia University’s Lab-to-Market Accelerator Network, sponsored by InvenTrust, focusing on clinical trials participant recruitment. This topic is now more topical, for at least three reasons:
- The urgent need for a vaccine for the COVID-19 coronavirus;
- The (slightly less urgent) need for better pandemic preparation generally, including more vaccine research; and
- The unique challenges of vaccine trials, which better participant recruitment could contribute to overcoming.
Go to the hackathon website to learn more and sign up. The hackathon is open to anyone over 18, and its hybrid online/on-site structure allows for entirely virtual participation. All are encouraged to participate, whether they have backgrounds in computer science, medical research, marketing, or other domains that they believe are applicable. The hackathon does NOT require expertise in medicine or clinical research, because it is focused on the challenge of participant recruitment, which is inter-disciplinary. For more background on the recruitment challenge in this hackathon, read here and here. For more on why the COVID-19 crisis should encourage you to participate, read on.
Climate Change Threat Has Nothing On Pandemics
So what’s the bigger problem: climate change or pandemics? In 2017, the World Health Organization (WHO), in the news lately regarding you-know-what, actually weighed in on climate change as follows: “Between 2030 and 2050, climate change is expected to cause approximately 250,000 additional deaths per year, from malnutrition, malaria, diarrhea and heat stress.” The Spanish flu of 1918, with which you are likely more familiar now than a month ago, caused an estimated 50–100 million deaths in a year. That compares to the roughly 5 million in deaths from climate change predicted by the WHO over 20 years.
The COVID-19 outbreak (not a pandemic, yet) is the current concern. COVID-19 has already resulted in over 3,000 reported deaths globally. Containment appears unlikely. The virus’ mortality rate — difficult to estimate at this early stage, when the number of cases is likely understated — is probably higher than that of the flu. COVID-19’s transmissibility (i.e., its basic reproduction rate, or R0) seems higher than the flu’s as well. The U.S. Centers for Disease Control and Prevention (CDC) estimates that the flu has already resulted in an estimated 18,000–46,000 deaths in the U.S. since October 1, 2019, and the CDC has estimated that the flu results in 291,000–646,000 annual deaths globally.
For a generation fixated on global warming as its existential threat, the outbreak of the coronavirus is a reminder that there are other global threats worthy of attention. In a 2015 TED talk, Bill Gates opined that the “greatest risk of global catastrophe is not nuclear war, but a highly infectious virus.”
Vaccine Trials Are Increasingly Vital
The race for a coronavirus vaccine (or vaccines) has begun. Candidate vaccines against the COVID-19 virus are slated to begin clinical trials this spring.
More broadly, vaccines are part of the prevention infrastructure. For almost 70 years, the Global Influenza Surveillance and Response System has monitored new flu strains, and helped identify the most threatening strains each flu season. This infrastructure has greatly contributed to anticipating flu outbreaks, facilitating the availability of appropriate vaccines each year.
Thus, whether now, for COVID-19, or in the future, as part of regular pandemic preparedness, vaccine trials will be increasingly necessary. As stated in 2018 in the International Journal of Environmental Research and Public Health: “Vaccine trials are imperative for the development of vaccines that can prevent an individual from acquiring a disease or condition and prevent the spread of the condition in the community.”
Clinical Trials Need To Improve
Vaccine trials are a form of clinical trial and, as we have noted previously, clinical trial methods have room for improvement, such as in the recruitment and retention of participants. Rising clinical trial costs and increased research into “patient-centric” therapies have led to surging demand for technology solutions for clinical trials, such as artificial intelligence for identifying potential recruits and virtual clinical trials to expand trial reach to participants and reduce the costs and time necessary to complete the trials.
Vaccine trials highlight a number of particular challenges to participant recruitment. These include:
- Obtaining the right demographic mix of participants. It can be difficult to recruit sufficient numbers of populations like the very young, the very elderly, and pregnant women. Under-recruitment of the elderly can cause a general problem in vaccine trials because the “elderly differ from younger populations in terms of pharmacodynamics, pharmacokinetics, and study product responses.” Shortfalls in elderly recruitment could be a particular problem for COVID-19 trials, as the elderly appear substantially more susceptible to severe health consequences.
- The additional screening criteria often involved in viral challenge tests. The scope of participant outreach may need to be substantially larger for a viral challenge trial than for other types of clinical trials because of the additional exclusion criteria imposed on viral challenge trial participants.
- Social factors that can skew participation. For example, certain populations are more distrustful of vaccines and vaccine researchers, reflecting past unethical research practices. Perceived stigma of certain conditions can discourage needed recruits from participating.
- Mismatches between recruited populations and testing infrastructure. For example, trials may target afflicted populations in developing countries, which often have more limited numbers of testing sites.
Lots of Spin-off Recruitment Applications
Those perhaps concerned that the hackathon may be too specialized or narrow in focus should recognize that the tools for recruitment at issue likely have applications well beyond clinical trials. Let’s consider just a few of the concentric circles of recruitment applications expanding outward from clinical trials. Near the center is recruitment of recovered patients to donate blood plasma. For example, the Chinese government is reportedly considering patient incentives to expedite this process. Recruiting donors of all kinds (such as of money or time) is critical to charities and other philanthropic organizations. Recruiting supporters is vital to political campaigns. The hackathon leaves it to your imagination to consider the other possibilities for improvements in recruitment.
After practicing corporate and securities law, I began my career on Wall Street as an equity research analyst in the technology media telecom sector at Deutsche Bank in 1999. Since 2017, I have advised clients on media investing and fundraising, blockchain applications, and the use of digital incentives in advertising. I have a BA in Economics and an MBA from the University of Chicago, a JD from the University of Virginia School of Law, and am a CFA Charterholder.
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