Virtual Industry revenues will reach to $7.2 billion globally by the end of 2017 as in Greenlight Insight’s latest report. Anticipating modest growth in the short term, expects the Virtual industry to grow into a major global marketplace by 2021, reaching $74.8 billion in global revenues. Virtual industry remarkably uses cases including Tourism, Education, Sales and Marketing, designing and sports coaching.
How about on Clinical Trial Industry?
Clinical Trial industry is facing crisis, nearly 80% of trials do not meet enrollment timelines, and these delays can amount to $8 million in lost revenues per day, according to one estimate by Cutting edge information. But now the industry is preparing to bet on new trend: Virtual Clinical Trials. Virtual Clinical Trials represent a relatively new method of collecting safety and efficacy data from clinical trial participants. Imaging few scenario on this.
- Patients do not travel to sites.
- Devices (it can be mobile, watch, glass) link to the clinical research study and reporting general information including Adverse Events.
- Device’s sensors record data like body temperature, blood glucose levels and which are sent automatically to EDC record.
- Study personnel visits at patient’s home for drug administration and follow up.
- Whenever visits are approaching, mobile device provide automated reminders and allowing them to reschedule according to protocol.
- And this is just beginning of what the future is likely to hold for virtual clinical trials.
- Evolve in Virtual Clinical Trial (VCT):
- Pfizer evolved the VCT model with its Research on Electronic Monitoring of Overactive bladder Treatment Experience (REMOTE) trial in 2011. It was the first randomized clinical trial using web and smartphone based recruitment, enrollment and collection of study data without requiring patients to visit a site.
Experiences: It was halted in 2012 because of poor recruitment. Patient recruitment (most members of the target patient group were older), so the use of technology based trial was an unknown.
2. Sanofi announced its intention to support a virtual diabetes trail (VERKKO) to be conducted remotely in Europe in 2015. Instead of testing drug, Pfizer’s trial did, Sanofi’s tested a wireless glucose meter in diabetes patients. Also it is the first clinical trial using an electronic ICF approved by European regulatory agencies.
Experiences: 97% retention rate and are completed at least 30% faster than a traditional trial.
- Although totally remote research is still a relatively new concept and still has limitations. VCT can be inappropriate for phase I and other acute problems like strokes which are probably a bad idea to monitor at home.
FDA is seeking on specific issues like how the FDA could encourage adoption of such tools, how new models of research will affect patients. FDA has established docket to gather feedback on how researchers are using technology and what are the barriers which are stopping.
Forthcoming of VCT:
- Patients who were previously excluded can now participate, for example patients living in rural areas would finally have a chance to enroll without travelling to a central center.
- Pfizer case study and FDA docket suggest multitude of challenges to come in the journey to make VCT a viable choice for study sponsors.
- Need to think differently on patient privacy and protection.
- Recruitment and retention of patients with low computer literacy is a major concern that can greatly impact the trial and data it generates. These are the scenario which seems convincing.
- Perhaps VCT can be used in rescue studies where traditional models have failed. Example: for geographically dispersed groups or rare disease populations.
- It will not be an easy road, but it is one likely to offer significant benefits for certain studies and select populations.
- Biggest roadblock to VCT adoption is the industry itself, which is highly regulated and slow to adopt new things.
- With supportive technologies and the right Virtual trial model, VCT is sure to become more popular in Pharma and medical device developers in near future.
If you make the trial easy, satisfying and rewarding for patients, they will want to take part. What is your opinion on VCT model?