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Clinical & Medical Affairs

Clinical trials must "embrace wearables as the way forward versus the current ‘monitored’ approach" - Access Afya founder

Posted by on 12 November 2018
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Melissa Menke is the Founder and CEO of Access Afya - an innovative healthcare company based in Kenya offering quality assured, patient centered care in some of Nairobi’s poorest communities.

Using the latest technology systems and rigorous process design, they've created a sustainable and scalable model for integrated community health. In this exclusive interview we asked her about how she sees wearables and other technologies being used to collect clinical data.

Menke is speaking on a panel exploring Wearables and sensors - Innovative ways to collect clinical data at Partnerships in Clinical Trials Europe in Barcelona on 29 November 2018.

How close are we to gathering reliable clinical data purely through wearables and sensors? What challenges need to be overcome?

We are in an advent period for the use of wearable devices in gathering clinical data, beyond just heart rates. Wearable monitoring has already been happening for years with such doctor-issued devices such as Holter monitors. It has been demonstrated that Parkinson’s Disease can be diagnosed by using standard smartphone sensors (accelerometers and gyroscopes) that detect and profile and individual’s gait pattern essentially using the same logic your smartphone counts the number of steps you have taken. New solutions such as Diabetes Sentry are proving that blood sugar monitoring at home can be successfully done in patients’ homes through wearables.

The immediate use for wearables is in a supportive and complementary role to standard on-site monitoring with potential benefits of reducing length of stay for patients and promoting ambulatory monitoring for at-risk patients. There are definitely aspects of clinical data that wearables and sensors can support in. But, they may not be able to fully provide information that requires observation (inspection) or invasive methods (blood testing) to determine. The Diabetes Sentry is one such example, it does not actually measure nor report on blood sugar levels.

To move towards more clinical data coming through wearables and sensors, both the physician and the trial participant will need to accept the technology and the data will need to be proven to be reliable versus the current gold standards. The regulatory authorities will need to adapt their processes and procedures to accept this kind of data as a normal part of the regulatory submission. The industry will need to embrace the technology as the way forward versus the current ‘monitored’ approach. We will also need to address the issue of standardization for the development of sensors for tracking physiological or biochemical markers. For example, is heart rate monitoring happening in a similar and reliable manner across smartwatches? There are results that indicate this is not true yet, which will hurt widespread take-up of these devices in the short-term.

What requirements should be considered when choosing the right device for a trial?

The main requirements will always be patient acceptability and reliability of the data produced. We should start with the easy stuff such as cardiovascular measures that are easily reproducible but the big area of interest appears to be in the area of brain research, particularly Parkinson’s and Alzheimer’s disease.

For progress to be made, there will need to a general agreement on what measures are important as end points and some reassurance that the different technologies match across the different patient populations. In Kenya, we are also interested in market availability and cost of devices. Ideally we would be working with the types of devices that would in the near future be accessible to this market.

What other new technologies will have the biggest impact?

The biggest impact going forward will be the use of big data to back extrapolate what is really important in developing new medicines and disease pathways. Critical to this will be the progress made in mapping the human genome and understanding the predictable nature of some diseases especially in the area of cancer and autoimmune disease.

How will trials look in 10 years?

The trial landscape will be more about following small populations real time using wearables and sensors in off-site locations. The purpose of this will be to produce data for government agencies and ministries to show the cost/benefit of such interventions versus current medical practice and system costs.

See Melissa Menke speaking at Partnerships in Clinical Trials Europe in Barcelona on 27 - 29 November 2018. Explore the full agenda or register for a pass.

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