How you see the world depends on where you are. From one side of a room, the shadow of a cylinder may appear as a square; from the other side, a circle. Each perspective is true to the observer, but the truth is that both are correct.

Similarly, the truth about global health is a tale of two worlds.

In one world, devastating diseases like HIV are becoming manageable, chronic conditions; roughly 30% of people living with HIV in the U.S. are virally suppressed. In the other, we are still trying to contain disease; Sub-Saharan Africa is home to 70% of the HIV+ population.

In one world, innovation is all about high-tech and personal devices such as 23andMe, the Apple Watch and motion-sensing gadgets. In the other, innovation means new ways of doing everyday tasks, like sack farming to grow food with minimal irrigation, or motorbike transport to deliver samples from patient to lab.

In one world, goals are business-driven. The focus is on growing profits, displacing the competition and advancing technology. In the other, goals are mission-driven, with the focus on incremental solutions that build capacity to make public health improvements.

This story of two worlds is an important context for clinical research to understand. Global health is not an “either/or” proposition. It is “both/and.” 

We are a global community—and we also are  a world of many communities. Africa alone has 53 countries with more than 1,250 official languages. Emerging markets are a world of extremes, a study in stark contrasts: the very rich and the very poor; the highly educated and highly undereducated; big cities and tiny villages.

The small-economy setting has important implications for clinical research practices that were developed and refined in the world’s largest economies. In those areas, the healthcare delivery environment is resource-rich, with centralized diagnostics and molecular testing, cheap electricity, specialized professions, broadband access, centralized communications and sterile facilities.

In emerging markets, the varying degrees of infrastructure, leadership competencies and governance present an entirely different set of expectations, both practical and aspirational, for clinical research.

Top healthcare leaders often are educated abroad and then brought back to their country to manage staffers who are under-resourced, undertrained and may have cultural beliefs and superstitions that influence their attitudes and behaviors. They may live in places where civil unrest or war is the norm.

Most care is delivered by general-practice primary care providers, including many who work in makeshift facilities with unpredictable conditions, where electricity can be sporadic at 10 times the cost. There may be valuable but unused equipment collecting dust because it is broken, or there aren’t the right people to run it.

Gathering informed consent using conventional paper-based systems, in nations with low literacy rates and a general lack of understanding of modern medicine, is ineffective. Think about volunteers who can’t read or write, have no access to basic healthcare and have very different ideas about health and disease. How are they supposed to comprehend pages they can’t read? How are they supposed to sign the forms? How tempted might they be to join the trial, thinking it is their only way of receiving medical treatment they desperately need?

It is not uncommon that emerging markets lack the rigid government oversight under which we operate in the U.S. to protect citizens from unethical treatment and coercion. Clinical trial sponsors must consider local market nuances in language and culture, and take steps to ensure individuals are protected in all trial sites.

Disease in emerging markets is a family- centered affair; it is about communities and public health. An HIV vaccine trial conducted in Kenya in 2000 taught us to look at informed consent from the patients’ point of view, through their cultural lens. The trial demonstrated success in ethically increasing volunteer recruitment and retention through a community effort that included:

• Training for community representatives;
• Informal community seminars;
• One-on-one counseling sessions before being considered for entry; and
• Mechanisms to evaluate how well interested candidates understood the nature of the research before they were invited to participate.

At a time when recruitment and retention goals for clinical trials are becoming more aggressive, it is more important than ever not to miscalculate the forecast for conducting clinical studies in emerging markets. Clinical research must be inclusive of all audiences. It must factor in the realities of resource constraints, and consider new paradigms for adapting conventional practices to local needs. 

Matthew Howes is senior vice president, marketing innovation for PALIO, an inVentiv Health company. Email matthew.howes@inventivhealth.com.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »