The Drugs for Neglected Diseases initiative (DNDi) has a unique mission: to use an alternative model to develop drugs for neglected diseases and ensure equitable access to treatment, thereby saving lives and improving people’s health.
DNDi was founded in 2003 by Médecins Sans Frontières (MSF) in collaboration with seven other partner organizations from around the world. For the past 20 years, the organization has collaborated with over 200 partners globally to develop treatments for diseases that have been overlooked by the market-driven research community. DNDi provides help where it is most needed, focusing on diseases that primarily affect lower- and middle-income countries, including sleeping sickness, leishmaniasis, Chagas disease, pediatric HIV, hepatitis C, and dengue fever.
When DNDi was ready to share the results of a clinical study comparing treatments for people living with HIV who had leishmaniasis, they turned to Privacy Analytics to anonymize the data for use in research beyond the data’s original intended purpose.
"Privacy Analytics has proven to be an expert guide for us in safely sharing insight-rich data to help those afflicted by some of the world’s rarest diseases."
Dr. Vishal Goyal,
Senior Medical Manager, Translational Sciences at DNDi
A vulnerable, geographically concentrated patient population
Each year, up to one million people around the world acquire leishmaniasis, a parasitic disease of the tropics. For those with leishmaniasis who live with HIV, relapse and mortality rates are dramatically increased. The highest prevalence of people with both these diseases is found in Brazil, Ethiopia, and the state of Bihar in India.
DNDi had worked with a research partner to conduct a study comparing the effectiveness of a single-drug treatment with a combination treatment for Ethiopian patients living with HIV who had leishmaniasis. Previously, the World Health Organization (WHO) had used published results from the study to change its treatment guidelines. DNDi now planned to make individual patient data from the study available to researchers, universities, and other organizations with a valid research interest via an infectious disease data repository. First, though, the data needed to be safely anonymized so that it could be shared with data requestors—a critical step for both regulatory and ethical reasons, especially considering the vulnerability of the patient population.
Doing so, however, would be unusually difficult given that the affected global population was both small and highly concentrated geographically. Any analysis of the chance of identifying someone in the data therefore needed to be based on relevant local statistics.
If certain data elements were suppressed, the data would be rendered useless for research beyond its original intended purpose. Privacy Analytics was tasked with finding a way to preserve the data’s value while protecting the privacy of patients represented in the data.
A standard process, carefully explained and expertly executed
Privacy Analytics’ Clinical Trial Transparency team proposed an analysis to determine the risk of identifying patients in the data followed by a data anonymization service. The team met with representatives from DNDi to discuss Privacy Analytics’ standard approach, albeit with the statistical wrinkle posed by the concentrated geography of the disease, which can make it easier in general to identify patients. “We had a productive discussion about approaches to measure the likelihood of people being identified in the data,” explained Dr. Vishal Goyal, Senior Medical Manager, Translational Sciences at DNDi. “The team led us through their intended processes very well. We understood, in the end, exactly what Privacy Analytics would be doing, and ultimately, there were no surprises for us.”
Once the likelihood of identifying someone in the data was determined, Privacy Analytics developed an anonymization strategy and presented it to DNDi for review and approval prior to implementing it. “This gave us an opportunity to explain, in detail, exactly which elements would be transformed in the database and which would remain the same,” said Michael Shelton, Technical Manager at Privacy Analytics. “The team at DNDi was eager to understand our process and to delve into the details. We were then able to proceed with the data anonymization, certain that the privacy protection would suit DNDi’s needs.”
Maximized benefits of clinical research
In making the anonymized clinical data available to other researchers around the world, DNDi is maximizing the benefit of the data on behalf of trial participants and other patients. DNDi hopes that making the data more widely available will bring about other treatment advances and save lives. Combined with other data sets, the data can potentially be used to understand the disease better and to accelerate clinical trials and treatment development.
The DNDi database is especially precious since very few clinical trials have been conducted involving people living with HIV who have leishmaniasis, and few organizations are focused on pursuing treatments. With the availability of this data, other researchers can plan their own research initiatives and allocate their resources accordingly. They can therefore focus on complementary work that builds on this research.
DNDi is preparing for the future. “Thanks to the pilot that we ran with Privacy Analytics, we now understand the complexities involved in transforming data prior to sharing it,” added Dr. Goyal. “We’re currently working on different data sharing plans and standard operating procedures (SOPs), and we’re building into our grant proposals for future studies the need to anonymize data. Privacy Analytics has proven to be an expert guide for us in safely sharing insight-rich data to help those afflicted by some of the world’s rarest diseases.”