Current trends indicate a shift from an efficiency-centric approach to a focus on accuracy and patient centricity in data collection. Is your team ready to embrace the changes in clinical technology?
The world of clinical trials is going through a metamorphosis of sorts. Paper diaries will soon be phased out, and gone are the days of daily site visits that greatly limited those patients without travel arrangements. Technology has changed this landscape for the better, and new advancements are achieved every day. Here are 3 of the top trends in clinical trial data collection to watch this year.
1. Data collection in lower cost areas.
By streamlining transmission of clinical trial data, eCOA and ePRO tools such as smartphones and tablets allow sites to monitor patients all over the world, instead of limiting the patient pool to those who have regular accessibility to a study site. This benefit has particular application for phase III trials which are often conducted across multiple countries with hundreds of subjects. These areas often have a high concentration of untreated patients with limited access to regulated health care; making these underdeveloped nations ideal for phase III clinical trials. While this market does not lend itself well to the BYOD approach, it is nonetheless an area of tremendous need and significant profitability potential, given the extremely low cost of conducting trials in these regions. eCOA and ePRO devices can eliminate the inaccuracies that occur with paper diaries and automate the data collection process. By deploying smartphones and tablets for clinical trials in low cost regions, sponsors and CROs can shorten trial timelines and provide care to those who would not otherwise have access to treatment.
2. Clinical Grade Wearables.
Wearable fitness trackers have been available to consumers for years now. Unfortunately, their capabilities have been underutilized in healthcare. Health and wellness devices, like the Fitbit wristband, conveniently track physical activity based on smartphone and GPS technology. For the clinical trial space, where methods of data collection need to be regulated, sponsors are hesitant to adopt these commercial devices. This is where the new wave of clinical grade wearables comes into play. While brands like Phillips and Spry Health are developing wearables designed for clinical data collection, sponsors and CROs need to take the leap to implement these technologies into trials. A successful pioneer study is the surest way to get regulatory acceptance of these methods.
Biosensors are a step or two above wearable trackers. These devices can be ingested, implanted, or worn directly on the skin and are used to detect and/or monitor biological responses. They provide the opportunity to get highly-detailed and accurate monitoring of a patient’s physiology and behavior which can then be converted into measurable data. This information can lead to early detection of diseases and greatly benefit those with chronic conditions as they improve our understanding of a disease and a patient’s response to medication. Biosensors like Braveheart wireless life sensors and iRhythm’s Zio patch can continuously monitor a subject’s vitals and activity, and can even regulate doses. The end result is a much more robust collection of data with minimal interruption to a patient’s day-to-day life.
At this point, the barriers to these advancements are more regulatory than technological. Ultimately, if pharmaceutical and biotech companies utilize these technological advancements, they can create a more efficient drug development process. These trending technologies have the capability to vastly improve patient care and drug development; only time will tell how vast their applications can be.