The last several years have seen a number of high-profile disease outbreaks across the developing world. Ebola struck three West African nations in 2014, mobilizing the World Health Organization and bringing doctors from around the world to the affected areas. The following year, the Zika virus spread throughout major portions of Latin America, with significant impact reaching as far north as Miami, Florida.
Events like these have led to calls for expedited approvals of vaccines and drugs undergoing clinical trials in order to nip these and future outbreaks in the bud. Part of that discussion has involved the question of how to strengthen clinical research infrastructure in the developing world, where outbreaks tend to have the largest impact. A recent report from the National Academies of Sciences, Engineering, and Medicine argues that safety and efficacy trials on compounds to fight outbreaks should engage the populations most likely to be affected by those outbreaks, and that it’s therefore essential to ensure that those trials can take place in the regions where those populations live.1 How can eClinical technology equip clinical researchers to make this happen? And how can researchers optimize access to that technology in regions with limited resources?
A key eSource functionality
Web-based electronic data capture (EDC) has been revolutionary in streamlining clinical research operations, but depends on a strong enough infrastructure to ensure web access. As outbreaks like Ebola and Zika tend to take place in the developing world, internet access in the affected areas can be limited. Without a reliable enough internet infrastructure to utilize EDC and other eClinical tools, studies will have to rely on the much slower process of paper-based data management – an alternative which, given the speed with which outbreaks spread and the urgency of finding vaccinations and treatments, is simply unfeasible.
As more clinical trial sites begin to adopt eSource tools, however, researchers may find a way around this problem. While not universal, some eSource applications come equipped with offline data entry functionality, allowing users to collect data from subjects and store it in the system even without an internet connection. The data later syncs with the study’s EDC system, which can be established remotely, in an area with stronger infrastructure, when a connection is restored. Offline data entry is a key lifeline for sites in rural or remote areas, or anywhere that lacks reliable internet access. For vaccine trials aiming to preempt the next outbreak in the developing world, it can signify the ability to access the technology that offers the efficiency they need, even with limited research infrastructure.
Of course, there’s also the question of whether the cost of such technology is practical in the low-income regions where these outbreaks tend to occur. The report cited above notes that the total combined cost of development and research of a drug can number in the billions of dollars – at first, eClinical technology can appear to be simply another expense. This expense, however, is mitigated by the time savings eSource and other eClinical tools make possible. In addition, it may not be as expensive as researchers may fear. Medrio’s eSource applications, for example, are equipped with offline-data entry, and are among the most affordable in their field.
The individuals conducting and participating in clinical trials at the sites of infectious disease outbreaks are noble and courageous, and deserve to be equipped with the tools and resources necessary to find treatments and vaccinations as quickly as possible. An affordable eClinical solution equipped with the right kind of functionality can help achieve this.
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1 New report on how to improve speed, effectiveness of clinical trials during an epidemic; National Academies of Sciences, Engineering, and Medicine; 12 April 2017