Integrated Biometrics & Mali-UCRC

Incorrect or incomplete data results in far-reaching consequences. As public health institutions worldwide race to develop and perform clinical tests on vaccines for infectious diseases, poor data management leads to delays, which in turn leads to greater global risk. 

Our solution utilizes fingerprint biometrics to link clinical test subjects to their individual test data at each stage of clinical studies, resulting in more accurate, complete data. This proposed solution is in partnership with the Mali-University Clinical Research Center (UCRC), an initiative between the Malian Ministry of Health, the Ministry of Higher Education, the University of Science, Technology and Technology of Bamako, and the United States National Institute of Allergy and Infectious Diseases. 

It is crucial that clinical trials investigating infectious diseases and vaccines are efficient and accurate. If scaled globally, this solution will greatly contribute to the detecting, slowing, and halting of future disease outbreaks.

Poor data management is both common and costly for everyone. According to a 2018 article by the Association of Clinical Research Professionals, nearly 60% of clinical researchers said that data management hurdles had delayed their trials; more than 40% said it was causing them to miss critical trial issues that put patients or the trial at risk. Examples of problems encountered by researchers include missing patient data (cited by 77% of respondents), patients missing visits (44%), out of range data (39%), and that the patient should not have been enrolled at the outset (28%).

Incomplete and inaccurate data can lead to delays, retrials, or unreliable conclusions; this is a universal issue. In the context of vaccine development for infectious diseases and global pandemics, the stakes of data management are incredibly high. Clinical trials for vaccines usually span multiple stages, multiple locations, multiple organizations and teams, multiple countries and languages, and thousands of test subjects. With all these different variables at play, there is plenty of room for errors to occur. 

Our solution improves data management by ensuring accuracy and completeness for every step of a subject's participation in a clinical trial. Our solution consists of a fingerprint scanner that is connected to either a computer or a tablet; subjects scan their fingers to enroll at the beginning of a study, and then again at every subsequent visit to verify their identities. 

Each subject is given a unique identifier number, and fingerprint biometrics ensure that each unique identifier number is linked to the individual health and testing data associated with each number.

This proposed solution utilizes Integrated Biometrics' fingerprint scanners, which are FBI-certified, mobile, suitable for large-volume use, and work in all weather conditions.

This solution benefits both clinical researchers and their institutions, many of which face budget constraints. A popular present-day approach by organizations with limited resources involves providing subjects with identification cards that are presented throughout clinical trials. However, as clinical trials for vaccines often entail multiple visits and sites, cards are forgotten, lost, or exchanged, which in turn lead to inaccurate or incomplete data. A solution that utilizes fingerprint biometrics to link patient identities to individual data ultimately saves time for researchers, decreases the potential for human error, and enhances the reliability of the work produced by research institutions.

This proposal was developed in conjunction with Mr. Ayouba Diarra of the Mali-University Clinical Research Center (UCRC) in Bamako, Mali. Mr. Diarra leads the Data Management Unit at UCRC and plays an ongoing key role in helping us better understand the solution's target population, as well as their needs. UCRC leads clinical studies on vaccines for ebola, malaria, lassa fever, and HIV/AIDS (to name a few) - all involving thousands or tens of thousands of participants. UCRC currently uses the aforementioned identification cards for their subjects.

Changing the way tens of thousands of test subjects move through clinical trials increases the accuracy and completeness of data. By improving data quality from a systemic level, public health institutions will be able to carry out research on detecting, slowing, and halting disease outbreaks more effectively.

Integrated Biometrics has been in business for over a decade and our technology is presently being used by millions of people worldwide. For example, just within the African continent, examples of case studies include:

• Securing patient identities in rural Kenya
• Anonymizing the HIV-testing process in South Africa
• Voter registration in Guinea
• Nationwide financial inclusion in Nigeria

We know from past projects that our fingerprint scanners can be used to link individual identity to digital records. We have not used our technology for the exact use case in this proposal (to improve data management within the context of clinical trials) before, but our history suggests that, with the right resources and support, the execution of this specific project is well within our capabilities. We are excited to further expand our project scope into Mali-UCRC and beyond.

A popular present-day approach by organizations with limited resources involves providing subjects with identification cards that are presented throughout clinical trials. (Mali-UCRC also currently uses these identification cards for their clinical trial participants.) However, as clinical trials for vaccines often entail multiple visits and sites, cards are forgotten, lost, or exchanged, which in turn lead to inaccurate or incomplete data. Our solution, which utilizes fingerprint biometrics to link patient identities to individual data, saves time for researchers and decreases the potential for data errors.

We believe that this proposal is a game-changer in the clinical research space. Changing the way tens of thousands of test subjects identify themselves throughout various stages of clinical trials increases the accuracy and completeness of data. By improving data quality from a systemic level, public health institutions will be able to carry out research on detecting, slowing, and halting disease outbreaks more effectively. 

Fingerprint biometric technology is not confined to a single territory or spoken language, and is therefore easily implementable on a larger scale if our proposed project at Mali-UCRC is successful. The success of this project leads to capacity building: an increased awareness of the potential of fingerprint biometric technology and greater efforts to apply this technology elsewhere for additional social impacts.

Our proposed solution is not currently in existence, but it utilizes a technology that is presently widely used and will be adapted for this specific purpose.

Currently: 0

In one year: 65,000 people - the estimated number of people participating in ongoing studies on malaria, lassa fever, and ebola vaccinations at Mali-UCRC.

In five years: >650,000 people if a similar solution can be rolled out at 10 similar institutions, with additional direct (but hard to define) positive impacts as a result the improved detecting, slowing, and halting of future disease outbreaks.

Doing before/after studies on the user experiences of clinical trial participants, measuring the number of data errors that occur, internal surveys with research investigators, and audits.

As we work towards greater inclusion, it’s crucial to develop user-centric solutions. In other words: how do we center the very same people whose lives we want to improve? Firstly, it is important to develop a comprehensive understanding of situational context and customs. We must put in great effort to understand the challenges that our target audience face on a case-by-case basis by talking to them and listening to them, by stepping outside of our own bubble, seeing things through their lenses, and not making assumptions. Secondly, for best results, we must include our target audience in all levels of the development and deployment of solutions, understanding that situational context and customs regularly shape the way ideas are perceived and received.

Continuous improvement is a big part of our ethos; we want to learn more and grow in our approaches to social impact. We learned a lot from completing the MITx Business and Impact Planning for Social Enterprises course, and want to take the next step in challenging ourselves. In particular: we are especially interested in receiving guidance and training in strategy and development, pitching to investors and grant-awarding organizations, public relations, and measuring impact. We are very interested in participating in a community that is intentionally nurturing this growth.

Health is a fundamental human right, and our proposed solution seeks to enable greater efficiency in the development of vaccines and study of infectious diseases, regardless of region. We would use The AI for Humanity Prize towards rolling out our first project location in Mali-UCRC, hopefully the first of many.