The Gift of RCTs Keeps on Giving

rctgift

 

Just before the holidays, a monumental RCT delivered an early gift. In what is being hailed as a “scientific triumph,” a vaccination trial documented 100% protection against the Ebola virus. You read that correctly: 100%. In several prior posts, I’ve discussed how RCTs have transformed the medical profession. In this case, one can’t help but be overwhelmed by the tremendous success of randomized evaluation.

Although the drug has not yet been formally approved for widespread use, the results of the 2015 trial suggest that it could be soon. The study, which covered 11,841 people in the West African nation of Guinea, already has prompted increased production and storage of the vaccine. Why? Of the 5,837 people treated with the vaccine, none came down with Ebola after the standard 10-day waiting period for positive tests. Among the control group that did not receive the vaccination, only 23 people contracted Ebola.

The Ebola outbreak and the development of a vaccine amidst crisis makes for an intriguing case study. The 23 positive diagnoses among the control group, compared to the 11,000 lost lives in 2014, probably are a function of other drastic efforts at containing the virus. Although the disease had been around for some time, most attempts to combat Ebola’s spread followed a “contain and stifle” approach. But when thousands of people in Guinea and surrounding countries started contracting the disease, that resource-intensive strategy did not prove scalable.

Ebola dominated the news, and cases outside of Africa stoked additional fear. With the outbreak came a “[u]nique opportunity: Never before had the disease affected enough people to allow researchers to test Ebola drugs and vaccines in a real-world setting. As the number of cases exploded in mid-2014, they set in motion a vast research program that operated at breakneck speed.” The clinical trials encountered their own problems. Money dried up, and patient numbers fell as the outbreak waned. In other words the trials suffered from so-called “thin harvest,” making it difficult to conduct studies with adequate sample sizes.

The researchers who developed the new vaccine responded to this challenge with an innovative research method focused on randomizing “ring clusters,” by which entire circles of people closely connected to an Ebola patient are sorted into treatment and control groups. This study design not only increased the sample size, it also made sense in the light of how Ebola affects populations. The virus is communicated mainly through family and social networks, even among mourners who attend a deceased patient’s funeral. This approach “ensured that the study was undertaken in pockets of high incidence . . . despite the declining epidemic and an overall low attack rate.”

Funding and pooling service providers to conduct RCTs in the legal field of course encounter similar obstacles. Variation in the numbers of cases and types of services offered is analogous to the fluctuating numbers of Ebola patients for a drug trial. As mentioned in our series on triage, legal resources and services will always be scarce. More people than the system can accommodate need legal services. This fact will remain a constant. The silver lining is that, as resources are spread thin or do not reach everyone in need, such scarcity lays some of the ethical foundation for experimentation. And randomized methodologies, as we know, are the optimal strategies for discovering how best to help the underserved.

In addition, when considering the phenomenal Ebola vaccine account, legal RCTs might present opportunities beyond just learning about a specific intervention. We might also gain insight into new legal rules and how to construct preventative (or ex ante), rather than just prescriptive services. That said, we don’t kid ourselves by hoping for 100% effectiveness in any A2J Lab study, but we are heartened by the continued success of medical RCTs and the promise of similar discovery in our randomized legal studies. 

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