David Ignatius - Clinical Operations | 03 Jan 2017
We have seen an enormous change in recent years in the clinical research space due to advancements in technology and innovation. Today we are able to access data real-time which helps with real-time analysis.
Not long ago, clinical trial data was captured on paper CRFs which was entered manually at the sites. With global stakeholders involved across various locations, the physical movement of the data had its share of limitations in terms of time and accuracy.
The advent of electronic systems and electronic CRFs has certainly addressed those limitations, which is critical in the context of finding a better cure. With the use of technology and innovation, we are also seeing a significant benefit in terms of cost and effort.
This rapid advancement in the use of technology in clinical research had to deal with its share of roadblocks due to regulatory constraints. We recognize that regulation plays a pivotal role in the clinical space. However, it has not been able to keep pace with the speed of technological advancement.
Now with the availability of various mobile technologies and integrated wireless devices and the cloud technology advantage, we can expect enormous opportunities which the industry will benefit from. Although the acceptance to these has been rather slow, according to a survey conducted by Applied Clinical Trials, this is surely changing over time.
The devices have become smarter and are not only a source of data but also make meaningful information out of it. The IoT has become part of various sectors due to the advancement of technology. It is slowly but surely being used in healthcare and clinical trials. With the help of latest technologies, the smart devices can talk to other devices and data is being transferred across systems globally real-time.
It is now possible to have a Bluetooth enabled medical device send data to a mobile application, and eventually as a case report form. The data is both real-time and accurate while the patient continues with his/her daily routine and is not required to visit the clinic. The devices available today are so varied; even complex health related readings are now possible. According to a leading technology research organization, the number of smart devices currently available is over five billion and is likely to grow to 25 billion by 2020. This will allow a physician to monitor the patient constantly throughout the lifecycle of the clinical trial and also provide solutions that are specific to the patient at a faster pace. This will rule out many of the time-consuming and error-prone tasks that existed, while drastically improving both patient and physician experience.
Here are some of the IoT applications across the Pharma value chain helping pharma companies in providing better patient care.
Patients with Asthma and COPD can use tools like Amiko to monitor dosage and use of their medications. This data is transmitted back to the pharmacies in order to provide better medication management.
Connected packages and medication dispensers such as MedMinder and CleverCap are being used to help patients in adhering to their treatments.
Wearable devices are being used for real-time health reporting.
Sensors and devices are being used to monitor clinical sites, subjects screening and real-time reporting.
Drug efficacies data and health information are being routed back to R&D systems.
Predictive analytics on the data fed to the analytics engine is being used to control adverse events.
Health statistics are shared with HCPs and Providers to control drug dosage & intensity levels.
Digitized drug data is being directly fed to regulatory bodies helping in clinical trials as well as post drug launch. A leading cardiac rhythm management company is building a platform to ingest and analyze patient-generated cardiac data. The vast data will be used for real-time patient monitoring and will enable doctors to prevent episodes of care.
In summary, technology and software companies have become more and more involved in the clinical research space and brought in their share of expertise, which has brought large gains to the clinical industry. This trend is bound to continue as long as they are able to demonstrate that, technology with all its advancement and ease of use, brings with it security and traceability.
The Internet of Things (IoT) refers to the ever growing network of physical objects that feature an IP address for internet connectivity, and the communications that occur between these objects and other Internet-enabled devices and systems. (Webopedia)
All knowledge, eventually, becomes obsolete, or freely available, and thus ceases to be the basis for a lasting competitive advantage. It is not the stock of a company’s knowledge which provides a competitive advantage; it is the capacity to innovate, to develop new knowledge that matters (Hodgson and Crainer, 1993).