Virtual Clinical Trials: A complete Remote concept

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):
    1. 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?AAEAAQAAAAAAAA2IAAAAJDgxYzI4MmQ4LTNkZjktNDJlOS05MzE5LTczMTFkMWFjYzRmZg.png

Big Challenges ahead/new Ideas to try- Need these five steps to Evaluate and Learn

Nobody knows everything:

Nobody knows everything, not even the CEO. Need to incorporate information from many sources. Instead, the information is distributed asymmetrically across the team and across the company. In this process, we have got to gather it and make sense of it and asking the experts is the best and fastest way to do that.

With luck, we chose our work because of bold vision. We want to deliver that vision to the world whether it is a message or service or an experience software or even a story or an idea. But bringing a vision to life is difficult. It I s always easy to get in endless emails, deadline that slip, meeting that burn up day, a long term projects based on questionable assumptions. It does not have to be that way.

If there is any idea, big challenge and not quite enough time and if we could not prove that idea was viable in that time, then it switches to different projects/ideas. We need encouragement in Clinical Trial industry on experiment not only in the Investigational Products but in the methods used by individuals. I have observed several times that whenever we came up with new design, we failed to test our prototype, and not testing the design with users and end users.

Patient Enrollment Challenges for Clinical Trials Industry:

Clinical Trials provide access to the latest treatments. For some patients that means drugs which might save their lives. But trials are not just about new drugs- they are also about better data. The data from every trial is collected and organized, helping researchers learn about the efficacy of new and existing therapies. Only 4 percent of all cancer patients are in clinical trials. The other 96 percent of cancer treatment data is unavailable to doctors and researchers who might use it to better understand the disease and better treat future patients.

This kind of challenge – wanted to make trials available to anyone who was eligible, hoped to build software tool to help cancer clinics match patients to trials- a painstaking job to do manually, and perhaps the biggest hurdle to trial enrollment. Patients with common forms of cancer might qualify for trials reexamining the efficacy of standard treatment. Patients with rare forms of the disease might qualify for a new, highly targeted therapy. There were so many unique patients and so many trials that it was too much for any human to track.

This process an unconventional approach that focuses on the whole customer experience instead of individual components or technologies. Nobody is sure whether their solutions to the company/industry are good, at the end of the process we get the answers.

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Risk Based Monitoring/Centralized Monitoring Model for Clinical Research

It is an evolving paradigm and which require new skills and thinking part of stakeholders across the clinical research spectrum. While changes can be difficult, it is incumbent on the industry to embrace a methodology that promises to enhance patient safety and improve data integrity. We must assess and refine their research process to identify and develop optimal monitoring strategies. We must take interviews to research coordinators at the sites on what they feel and how they react to our prototype and learn. Need to assess very carefully observe the reactions, then we need to believe what we see. This test makes the entire sprint worthwhile: at the end of the day, we will know how far we have to go, and we will know just what to do next.

When you get into regular rhythm of listening to users, it can remind you why you are working so hard in the first place. After each process draws us closer to the people you are trying to help with product/service.

A winner every time:

And this is the best part about SPRINT that you cannot lose. If you test your prototype with customers, you will win the best prize of all- the chance to learn in just five steps/days, whether you are on right track with your ideas. Results do not follow a neat template, you can have efficient failures that are good news, flawed success that need more work, and many other outcomes. Let’s look at enrollment task and their results after this and what need to decide to do next.

Would cancer clinics change their workflow to use new tool? If they could convinced research coordinators to switch, they could enroll more patients in clinical trials. Coordinators did not love every part of the prototype, but their enthusiastic reaction to concept gave the confidence to continue designing and developing software.

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