Technology is bringing disruptive changes to the way clinical trials are organized today—from the electronic capture of patient data to real-time transmission of collected data. And the change is occurring on a global scale.
Half a world away from The Johns Hopkins Center for Clinical Global Health Education in Baltimore, a woman in a village in India is entering her medical information on a tablet and sharing it with clinical researchers of Johns Hopkins, who are studying the effects of TB on pregnant women. The ongoing study will benefit many patients like her across the world. Technology is bringing positive disruption to how clinical trials are organized today, especially in a global setting. The biggest challenge, however, remains the need to create an ecosystem that would enable them to transcend all barriers of disciplines, languages, countries, governments, and regulations.
The Johns Hopkins Center for Clinical Global Health Education, a not-for-profit entity, conducts clinical research on many of the gravest health issues facing low and middle-income countries, including tuberculosis and HIV. Johns Hopkins needed an automated solution to capture, store, classify, and categorize clinical research data so that they could more readily analyze and communicate data at patient and cohort levels in a global setting.
The Johns Hopkins team in Baltimore partnered with Persistent Systems, a global technology and software company, to build the Global Clinical Research Portal. The portal fundamentally advances how clinical trials and observational cohort studies for tuberculosis (TB) and HIV can be conducted in a global setting.
For instance, the Johns Hopkins team is working on accurately identifying the impact of TB on pregnant women, who are particularly vulnerable to TB as the Th-1 helper cell response, which is normally necessary for overcoming TB infection, is suppressed in pregnancy. The standard TB test frequently shows negative results in high-risk cohorts of patients. The team is, therefore, conducting clinical research at the BJ Government Medical College in Pune, India to see:
- If the current World Health Organization guidelines for TB screening can positively identify TB in HIV+ and HIV- pregnant women, and to see what differences in test accuracy there are between the two groups.
- If host factors such as diet, gut microbiome and inflammation can predict the progression of TB from latent to active state.
Another effort focuses on a longitudinal study in identifying if HIV+ patients are at greater risk for developing TB and non-communicable diseases such as coronary artery disease and diabetes mellitus. This is a global study involving more than 500+ participants in various cohorts.
Working with the team at Johns Hopkins, Persistent has developed a data management system for the portal that clinician scientists can use to derive important research findings and communicate more effectively with patients about health goals, treatment, and progress. The data management system hosted at Johns Hopkins, in Baltimore, can host all data collected from healthcare centers in far off places, such as Pune, and segregate, index and manage them to ensure the quality of data.
For the hand-held tablets, Persistent developed the software that Johns Hopkins could use to collaborate effectively with their research partners in Pune, India. The tablets enable Johns Hopkins to determine, along with their Indian counterpart, what information and capabilities would serve patients’ needs; expand their data analysis capabilities; and better equip clinicians
The dashboard enables researchers to holistically view patients across all touch points–including their medical histories, treatments, medications, other clinical data, and insights into social determinants–using a combination of visual graphics and charts. The dashboard also offers a detailed view of milestones achieved and those yet to complete, using pie charts, histograms and meaningful visuals. Such representation of data-guided doctor - or nurse-patient interactions helps them better understand their patients’ needs in taking informed decisions regarding intervention. It also empowers the caregivers to provide a more proactive and personalized care to their patients.
The tablet interface offers patients easy access to their health data and tracking the progress of their health goals. Such visual updates on their health progress have had a demonstrably positive impact on their attitude toward research studies, and their receptivity to improving their health by adhering to the prescription. It also encourages them to contribute to health outcomes at large. Since patients can now easily connect and interact with their healthcare providers in real-time to discuss matters of concern through the tablet interface, it reduces the gaps in care. The tablet-based interface has been useful in improving the overall patient experience in terms of care delivery and clinical research. According to Dr. Amita Gupta, “The experience of our patients when they come in and see us using the technology, is quite empowering, particularly when we use it to show them their data, having real-time monitoring and review of the quality of the data, and the completeness of the data. We can take a look at basic demographics with pie charts and histograms. Those visual pictures are incredibly informative.”
The data collector module has been set up directly on the tablets that connect to the research portal, where all data is centrally stored. Considering the remoteness and lack of proper data connectivity in low and middle-income countries, the data collector can also capture data offline where access to the internet is not reliable. The collected data can then be uploaded from the tablet to the central server later.
Technology is bringing a fresh approach to conducting clinical research across international and cultural boundaries. As a leading adopter of digital, Johns Hopkins is achieving breakthrough innovations in how data can be gathered and analyzed in cohort studies. The solution helps the center improve not only patient participation and accelerate clinical research but also compare different studies simultaneously to discover new insights into complexities affecting health conditions such as TB and HIV. It also helps the center understand how to prevent such complexities and improve chances of success and survival rates in high-risk cohorts of patients.