The clinical trial process is widely known to be complex and painstaking and is often criticized for not being sufficiently patient-centric. It therefore makes sense to innovate this area to ease the challenges, streamline the various activities and create patient engagement. One way to do this is via digital technology and mobile health.
In last month’s blog as well as our article in Journal For Clinical Trials, we talked about the potential for mHealth to facilitate drug development. Incorporating mobile technology within mHealth could not only streamline the processes, including the communication between the clinician and a patient, but also reduce the cost of clinical trials (and then ultimately the price of the drug itself). mHealth technologies might include apps developed for the patient’s own smart phone, or a specific device provided for the trial. However, in streamlining the process, clinical researchers also ought to consider the usage of a wearable tech in a clinical trial setting.
Wearable technology refers to electronic technologies or sensors that are incorporated into items of clothing and accessories, which can comfortably be worn on the body. More commonly this category of technology includes biometric tracking information related to health and fitness. As technology advances, intelligent sensors for an increasingly diverse range of metrics can be integrated into various accessories such as garments, wristbands, and other devices such as wristwatches, headphones as well as smartphones. In addition to this, there are wearables in the medical setting such as hand held electrocardiograph (ECG), ingestible smart pills that transmit data, body patches that captures physiological responses and smart inhalers with Bluetooth that could potentially streamline medical processes; in this case a clinical trial study.
There has been a lot of buzz about wearables. A report by the IHS mentions that, the global market for wearable tech will rise to $30 billion in revenue by 20181. However, there are contradicting perceptions to these statistics. A WIRED magazine article has mentioned how wearable technologies are failing the people who need them the most. Research conducted in the US showed that more than half its consumers who have owned an activity tracker do not continue to use it. It was mentioned as well that a third of them used them for less than six months before retiring it2.
It may seem that wearable technology’s evolution is not about the wearable itself i.e. gadget on the wrist for example, but with the data it collects and then what is done with the data. Using a wearable tech in a clinical trial study may boost the significance of the usage of the wearable tech as well as support the clinical study better.
As previously mentioned, clinical trials development is becoming ever more complex, specifically from the regulatory perspective, with greater emphasis on data .The need to accumulate more data to show modest benefits has resulted in drug companies investing more in patient recruitment for clinical trials, which further increases the cost. However, more data does not necessarily translate into beneficial data. What is more important is that we leverage real-time data analysis. The raw data from wearable technologies is often unstructured, and without an efficient analytical platform the value in the data is hard to extract. The usage of a wearable technology alone does not add value, but the benefits of an intelligent and interactive platform that allows real-time response to subject data is immense. Real time analytics can facilitate early intervention and response to anomalies, whilst real time feedback is shown to enhance patient engagement as well as reduce trial risks.
Having a variety of data points for a clinician to evaluate a certain therapeutic area of drug development also increases the prospects of trial success. Using sensors and wearables, the efficacy of treatments and outcomes of clinical trials can be better assessed. They help to track physiological changes from chronic conditions, as well as the progress of treatments on a continuous basis. Having structured analysis of additional data provided by these sensors may therefore provide the additional evidence needed to show the benefits of a certain drug, that otherwise could be missed.
Whilst innovation is crucial within clinical studies, success demands more than the mere adoption of the latest gadgets to keep up the pace with the growth of healthcare challenges. The real value is afforded in the capability of specialists like FirstApp who can unlock the value in the data with real time analysis via our intuitive platform. The benefits of having these platforms and dashboards with the key metrics needed to monitor trial progress at a glance in real-time enables clinical researchers to make on-the-spot and correct evaluations.
Usage of a wearable tech in a clinical trial could support therapy areas like cardiovascular, diabetes, respiratory and potentially infectious disease. With the intelligence of a real-time analytic platform, many other therapy areas could soon be reaping the benefits too. Combining effective data analytics with wearable technology can not only assist and compliment clinical trials and medical research, but could also enable innovation in many other sectors. So expect to see applications in sport, military, safety-critical industries, or any other sector where real time biometric monitoring can add value.
1 Note that this report includes infotainment, military and industrial markets, as well as health and fitness. IHS Electronic & Media. (2014). Wearable technology, market assessment. Available: http://proyecto.owliver.es/download/Informe_IHS.pdf. Last accessed 25th Feb 2015
2 Herz, J.C.. (2014). FOLLOW WIRED Twitter Facebook RSS Wearables Are Totally Failing the People Who Need Them Most. Available: http://www.wired.com/2014/11/where-fitness-trackers-fail/?mbid=social_twitter. Last accessed 15th Feb 2015
Published by Sarah Iqbal