UPDATED: This post was updated for 2017 to reflect new information and more examples. Enjoy!
Do you have a mobile strategy?
What does this mean? We keep hearing this question in various forms throughout the industry, but what does it actually mean? In this post, we work toward answering this question and outline what should be/what must be a mobile strategy for clinical researchers.
First, let’s look at the biggest problem in healthcare today: cost. Healthcare is unquestionably one of the most politically polarizing and contentious topics looming over the U.S. today. At every stage of the healthcare system, costs are astronomically high, and the clinical research industry is no exception.
Cost reduction should be a top priority for all clinical researchers – it’s that concept of the “greater good.” If we frontline troops can reduce our costs, that ultimately makes healthcare more available, which contributes to the “greater good.”
Now, back to the mobile strategy. Mobile phones and tablets have the potential to reduce the cost of a clinical trial by over 50 percent. They also have the potential to get the product to market in less than half the time. That will have a significant effect on the overall cost of healthcare. However, we must embrace new technology as an opportunity and not an obstacle. We cannot view technology as a risk; rather, we must view technology as a means to achieve the “greater good” in the healthcare system.
Currently, data used in clinical trials is still being captured on paper (source document) despite the great strides made in technological advancement. That paper data is then transcribed to an electronic Case Report Form. That CRF is submitted to an EDC system and resides in a database. However, to be compliant, everybody agrees that we must send an army of monitors to sites to validate that the data captured on the paper, matches the data on the CRF. That is an astronomical expense. In fact the cost of source data verification is so expensive and so alarming, that we have now developed Risk Based Monitoring (RBM) models. In short, RBM reduces the amount of data to be source verified, thus reducing the time of the monitor and the overall cost of a clinical trial. Sounds great doesn’t it? Well, in practice it has some serious flaws. For starters, it does not significantly reduce the time of the monitor. It has little – if any – effect on travel expenses and it certainly does not reduce the amount we pay the monitors. Ultimately, it does little or nothing to reduce the cost of clinical research. Very few of the trials being conducted today actually attempt to implement RBM. Ironically, it is one hot topic among technology companies. Source Data Verification/Monitoring can account for as much as 30 percent of the total cost of your trial and in some cases, double that!
Back to mobile devices: this sounds simple, but why do we source verify at all in the year 2017? It makes no sense. Clinical Studio’s sister product TrialKit, a native mobile app (available on the App Store and soon on Google Play) does this so well that CRFs on mobile devices are easier to complete than either the paper or browser-based CRF. Imagine the CRF becoming the source document…what would we have to source verify? In a word, nothing. We have clients who are already conducting paperless human trials that are Part 11 compliant. These trials cost half as much as a paper-based/EDC trial, and by eliminating the source verification process, we cut the time of the trial by 50 percent. Additionally, using TrialKit as opposed to an antiquated or overpriced EDC, renders a 90 percent savings on eClinical. Add it all up and you’ve just reduced the cost of your trial by 50 percent and reduced the amount of time to complete the trial by 50 percent – all by using TrialKit on a phone or tablet to capture data and eliminate the paper source document. Almost two-thirds of the world’s population now has a mobile phone, so there is no additional cost for the devices.
At the beginning of this document, we mentioned all researchers should have a mobile strategy and set lay out what the strategy should be. Here’s one way:
Through the use of existing mobile operating system technology and TrialKit, I can reduce the cost of my clinical trial by at least 50 percent while bringing my product to market in half the time. I will accomplish this by leveraging the latest in technology that TrialKit brings to bear in the mobile and Internet technology arenas. By doing so, I can eliminate the source verification piece altogether, which will be very beneficial to society as a whole, and as a result, will make healthcare more available.
This is why you need to have a mobile strategy. To learn more about TrialKit, schedule a demonstration with one of our product specialists today!