The pharmaceutical industry is moving in a direction where, in the not too distant future, a pause by the industry at the clinical trial crossroads will give rise to two roads diverging in a binary fashion. New innovations in terms of how clinical trials will be conducted, and with how new medicines will be approved by regulatory agencies. One road will lead the industry to innovations in the field of virtual clinical trials, where patients in a study will be monitored by their electronic mobile or wearable devices.
The other road will lead the industry to new developments in the field of personalized/precision medicine, where translational research and new genomic diagnostic tools will target specific patient profile features, and mitigate the risk of patient/screen failures in clinical trials. Technology will play a significant role in how innovation will drive these new processes, as technological developments in artificial intelligence, as well as in virtual and augmented reality platform tools, will play an integral part of a new paradigm shift in the industry.
The Rise of the Virtual Clinical Trial
In the near future, a cancer patient will be asked to participate in a virtual clinical trial. The patient will be contacted through their electronic/mobile device(s) from either the staff at the clinical research facility or from the doctor’s office. In thisvirtual clinical trial setting, the patient’s electronic/mobile device(s) could be a phone, a tablet, a watch, or a pair of glasses and will serve as the patient’s main link to the virtual clinical research study.
In addition, the patient’s electronic/mobile device(s) will provide through its portal system all relevant study information and adverse events outcomes that patient(s) will experience throughout the trial. The patient’s electronic medical record (EMR) will capture data such as body temperature, heart rate, weight, in addition to blood glucose levels, through wearable sensors on the patient’s electronic/mobile device(s), and the data will be transmitted automatically in real time to the study sponsor and to study site.
Study participation in virtual clinical trials will be conducted mainly from the patient’s home. Home visits will be scheduled by the patient and study personnel through the patient’s electronic/mobile device. Study personnel will have the ability to make scheduled periodic home visit(s) at the patient’s home for drug administration, blood draw, and for study follow-up. For the study sponsor, the benefits of conducting a virtual clinical trial are maximized through patient compliance for the duration of the study, and the immediate access to patient data. For the patient, the benefit will depend on the frequency of remote site interactions between themselvesand site personnel. Moreover, it’s incumbent upon site personnel to remain vigilant and engaged with the patient to ensure they comply for the duration of the study.
Will Virtual Clinical Trials soon become the norm?
With all the promise virtual clinical trials hold, what’s important to note is that these studies are not just an innovation for the future – they are already becoming part of the present. In 2011, Pfizer applied for and then received IND approval from the Food and Drug Administration (FDA) for the Phase IV, Research on Electronic Monitoring of Overactive Bladder Treatment Experience (REMOTE) trial (1). The REMOTE trial would be the first randomized virtual clinical trial to use a patient’s electronic/mobile device(s), and the study strategy centralized the electronic/mobile device(s) for patient recruitment, study enrollment, and the collection of study data. These benchmarks were achieved without requiring study patients to leave their home (1). Unfortunately, the REMOTE trial was besieged with many setbacks from the onset, and eventually Pfizer was forced to closethe study due to patient recruitment (1).
In 2015, Sanofi announced that it would hold its own virtual clinical trial in Europeto support a virtual diabetes trial (VERKKO) (2). Unlike Pfizer’s REMOTE study, the VERKKO trial did not test a drug for IND approval, but a device (2). The objectives of the VERKKO trial, developed in collaboration with Sanofi and three other organizations, were to study the use of a patient-centric online clinical trial platform integrated with a 3G-capable, wireless glucose meter that would automatically send patient blood glucose levels to both the study sites and the study sponsors (2).
Although both Pfizer and Sanofi’s studies used similar platforms in their trials, such as social media recruitment, Sanofi’s trial was more successful in recruiting patients, and more importantly, in garnering a high rating in patient compliance and in satisfactory surveys. The data points from the VERKKO trial will eventually be analyzed and models will be developed by the pharmaceutical industry to map how virtual clinical trials can be conducted efficiently and then strategically improved upon across therapeutic areas. For an industry where the bottom line drives innovation, the significant savings in cost from conducting clinical trials from a mobile device, and the immediate access to real time data, will ensure future investments in the platform.
*For more on this fascinating topic, read the second part of Keleni Tukia’s exploration of virtual clinical trials here
Keleni Micheal Tukia, M.D.
1) Pfizer Conducts First “Virtual” Clinical Trial Allowing Patients to Participate Regardless Of Geography.” 7 June 2011. Available at: http://press.pfizer.com/press-release/pfizer-conducts-first-virtual-clinical-trial-allowing-patients-participate-regardless-
2) “Europe's First Fully Remote Diabetes Trial Approved.” 10 February 2015. Available at: http://www.prnewswire.com/news-releases/europes-first-fully-remote-diabetes-trial-approved-291395161.html