Are your recruitment and retention goals for clinical trials in developing markets realistic?
Unless you’re addressing the challenge of informed consent in a multi-cultural context, the answer is probably “no.”
Gathering informed consent using conventional, paper-based systems is not optimally effective in developed countries with high literacy rates and a general understanding of modern medicine. In underdeveloped regions, it is almost entirely of no use.
Imagine volunteers who can’t read or write, with no access to basic healthcare, and who 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? Would they join the trial thinking it was their only way to receive the medical treatment they desperately need?
With the growth in global clinical trials outside the U.S. and U.K., our approach to informed consent should be reconsidered. Dr. Falguni Sen, director of the Global Healthcare Innovation Management Center at Fordham University, has studied the challenges of conducting clinical trials in India. In Conducting Clinical Trials: Is There An India Advantage?, he wrote, “A poor, maybe illiterate, population, with blind faith in doctors, having no other recourse to treatment, cannot really assess risk and benefits and rationally volunteer for a trial. In addition, if informed consent now is inadequately administered, it creates potential for exploitation.”
Indeed, 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. Sponsors must consider the local market nuances in language and culture and ensure individuals are protected in all sites. But our process of obtaining informed consent has evolved little over the years. Are we really are doing all we can?
An HIV vaccine trial conducted in Kenya in 2000 taught us to look at informed consent through the patients’ cultural lens. According to a presentation at the XV International AIDS Conference in 2004, the trial demonstrated success in ethically increasing recruitment and retention through a community effort that included:
Fast forward 14 years, and technology has made substantial advances that have revolutionized our ability to educate and communicate with underserved populations around the world. Mobile devices, interactive touch screens and electronic data capture are being leveraged broadly in other areas of healthcare. How can we combine lessons from 2000 with technology from 2014 to reinvent the process of explaining and obtaining informed consent?
A study published in March 2013 by PLOS One, Interactive Informed Consent: Randomized Comparison with Paper Consents, demonstrates significant improvement in both participant comprehension and participant engagement when using an iPad app. The premise of the study was that “many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject’s own pace with testing and immediate feedback.”
Mytrus, which developed the iPad application to collect informed consent digitally, originally was founded to “build a data system that could be used to explore a new model of research” leveraging remote access and virtual participation, CEO Anthony Costello told me. But the company discovered “while there is interest in doing virtual trials, there’s an urgent, unmet need for e-consent,” he said.
Electronic data capture is used in almost all other areas of clinical trial execution. Mytrus is attempting to shore up the last link in the data chain. More than just an electronic version of the consent document, it includes multimedia tools that allow patients to flag concepts they don’t understand, audio-recorded versions of the content and a review at the end. The app tests comprehension, and if patients don’t do well, it takes them back to the concepts with which they had trouble.
“Our mission is to make the trial participation experience better for patients,” said Costello. Mytrus currently is being deployed in a large-scale trial in India involving multiple language translations.
Before embarking on your next global trial, consider simple changes that can generate substantial impact. With digital innovations that focus on the patients’ needs, you can not only improve the user experience, but also improve your recruitment and retention rates.
Matthew Howes is head of strategic services at inVentiv Digital + Innovation, the digital center of excellence for inVentiv Health.
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