Digitalisation of clinical studies and the mushrooming needs for new expertise

Digitalisation will not stop disrupting our habits. Far from being a bad news,  this is an almost an inexhaustible source of opportunities for agile actors who are attentive to the evolution of industrial needs. The health field enters fully embraces this revolution too. What can we expect from it? According to the FDA : a reduction of inequality, a better access to health care, a cost reduction, an improvement of healthcare quality and, tomorrow, the promise of a personalised medicine[1].

Concretely, it means that a lot of information will be captured by wireless medical devices connected altogether ; that these information could be stored into databases or be locally treated by smartphones’ apps ; that doctors will have the possibility to consult them at any time or be alerted if an anomaly is detected ; that these data could be cleverly treated with algorithms to figure out images, to propose diagnostics, to set-up implanted medical devices. But why should we present it as future expectations ? These solutions already exist!

Clinical research should take benefits from technological evolution. Tomorrow’s research will be, even more than today, digital and connected. Portable connected objects, tracking technologies, mobile apps will improve the quality of clinical studies by reducing the cost and the duration of those. As an example of that :

  • The emancipation from geographical barriers: recruitment of patients in regions without medical facilities, far from huge clinical centers,
  • The improvement of patient compliance: alert triggered if the treatment is forgotten,
  • The emergence of new data : bigger, measured with a high frequency, synchronized, objective, requiring no medical intervention,
  • The management and conduct of clinical studies: a better access (in real time) to centralized data from studies,
  • The decrease of parameters’ variability : diminution of the needed number of patients without a comparison’s power loss.

Some examples among others illustrate the (r)evolution that is underway. Sanofi announces the launch of “numeric” clinical trials allowing the enrollment of patients away from investigation centers. Their hope? Speed up the recruitment phase and improve the representativeness of patients [2]. Janssen develops a clinical trial mobile platform with the ambition of reducing the development costs and improve the compliance[3]. The PROs (Patient Reported Outcomes) collect is more and more performed with smartphones applications. Verily developed a connected watch, the Study Watch, adapted to clinical trials requirements. This device has been used on 650 voluntaries in a Parkinson’s disease project[4]. In 2016, IBM set up a partnership to develop a package of   connected devices (sensors, mobile devices, machines) to enable a real time follow-up of Parkinson’s disease patients [5]. Fitbit, historically focused on a b2c market, started a shift towards the clinical research. The supply of 10000 devices for the research program “All of Us” promoted by NIH, shall enable the creation of a clinical database of more than one million of persons. This will enable researchers to study relations between physical activity, heart rate, sleep and other health markers [6].

The obstacles of connected clinical trials development, and widely to digitalisation, of health are not all removed. The exigencies of regulatory agencies are not clearly defined. How to consider these new data during a recording process? A round table with FDA representatives on health mobile question summed up the position of the american authority that wants reliable, reproducible, sensitive and specific measures [7] (but could we expect something less from clinical data ?). Nevertheless, not all mass market objects meet these requirements [8][9]. On their side, patients have good reasons to pay attention to these new technologies. What use for their data? Are they securely stored ? Could they be sold to third parties after being labelled “fitness/well-being” rather than “health” [10] ? How can they be sure that only the study promoter will have access to this data if it is collected with the help of mass market objects [11] ?

he emergence of connected objects brings technological players into clinical research; it also requires a new expertise for institutional actors such as laboratories or CRO. The choice of a sensor is as important as the study main criterion. Technological expertise must support medical and methodological expertise. This is the conclusion Soladis, which core business is data valuation, came to. To complete the historical know-how of its teams dedicated to clinical and data management (Soladis Clinical Studies) and biostatistics (Soladis Statistics), Soladis developed its expertise in the digital world (Soladis Digital) and measurement technologies (Soladis Connect) to answer to new/future client’s needs. Last-born of the group, Soladis Connect aims at creating new indicators from multi-channel data. This is the field of tailor-made solutions. Our engineers start from a medical issue, define specifications with our medical experts, select and test the existing (bio)sensors, enable them to communicate with each other, and derive data to aggregate them in common bases to carry out analysis. Soladis is able to take advantage of technological advances to build relevant data capture services in the very specific and regulated domain of clinical studies.

[1] https://www.fda.gov/MedicalDevices/DigitalHealth/default.htm

[2] http://mediaroom.sanofi.com/sanofi-lance-des-essais-cliniques-numeriques-pour-ameliorer-le-recrutement-des-patients-et-en-accelerer-la-conduite/

[3] https://medcitynews.com/2017/10/janssen-develops-mobile-clinical-trials-platform/?rf=1

[4] https://www.technologyreview.com/s/604198/googles-verily-unveils-a-health-watch-for-research/

[5] https://www.forbes.com/sites/emilymullin/2016/04/07/pfizer-ibm-launch-ambitious-internet-of-things-for-parkinsons-research/#564b97fd7618

[6] http://bit.ly/2A08vpd

[7] http://blog.mdsol.com/fda-wants-your-mhealth-clinical-trials/

[8] https://www.cnbc.com/2016/05/23/study-shows-fitbit-trackers-highly-inaccurate.html

[9] Case, Meredith A., et al. “Accuracy of smartphone applications and wearable devices for tracking physical activity data.” Jama313.6 (2015): 625-626.

[10] http://www.imperialcrs.com/blog/2016/02/wearables-in-cllinical-trials/

[11] https://www.lexology.com/library/detail.aspx?g=900d449d-34c3-4869-b056-34a06f66af2f

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Tél: +33(0)4.72.83.86.70
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