By some counts, prescription drug costs account for 20% of all healthcare costs. The cost of getting a drug to market reaching well over a billion dollars and there is a growing scrutiny of money-conscious consumers. It is not hard to see why pharma companies are searching to find ways to reduce costs.
Clinical trials rise to the top as one area in need of more cost-efficient methods. A recent analysis by the Manhattan Institute showed that over 90% of the cost of developing a drug comes from Phase III clinical trials. Several things drive up costs within these Phase III trials. Patient recruitment and retention and delays in setting up investigator sites drive up costs and negatively impact timelines.
A new approach to drive down these costs is “site-less”, or remote, clinical trials. In remote clinical trials, patients do not need to receive treatment by traveling to specific sites. Patients can have study visits in their own homes and receive medications in the mail. They can have pertinent health data transmitted over the internet via the ever-increasing technologies of mobile health.
Devices and apps like Fitbit, Apple Watch, Telcare, etc. can send everything from sleep duration/quality, blood pressure, blood sugar, activity levels, and heart rate. Radio Frequency Identification (RFID) chip technology is used to monitor medication administration. It can determine remotely if a patient has received the correct medication and dosage. The internet can also be leveraged to recruit patients using social media sites and to electronically sign and submit informed consent forms.
Going remote with clinical trials certainly has many advantages:
- More diverse subjects
- Better patient engagement
- Faster recruiting
- Greater patient retention
- More cost effective
However, as with anything new, there are also challenges and concerns. The use of such technologies may be prohibitive in more complex trials. Assuring healthcare data security is always an issue. It also may be more challenging for older patients to adopt the newer technologies associated with these kinds of studies.
Despite these roadblocks, remote clinical trials are becoming a serious consideration. Given the way the world has embraced digital technology over the last decade, it seems like it’s only a matter of time before this new way of conducting studies becomes the new norm. becomes the new norm.
Remote clinical trials and the increased use of mobile technologies in clinical trials seem inevitable. This will have impacts in many areas, including clinical project management. How will study managers need to adapt and change to this new world of clinical trials? The rise of site-less trials will change the way they manage the myriad moving parts of a study. This includes recruitment, monitoring, essential documents collection, and more.
Sure, the use of technology will lead to cost and time savings. But project managers are going to need to figure out the best ways to aggregate and arrange the data coming in from all these different electronic sources. Data arranged in a way that will provide a clear picture of how the study is tracking in terms of planned timelines, recruitment, and budget. Clearly, there will need to be a lot of thought put into how this is set up (and probably more than a little contribution from IT departments). But once you build the foundation, what follows is sure to revolutionize the running of clinical trials.