With the explosion of technology that can support a wide array of global collaboration and virtual engagement, virtual clinical trials should be commonplace at this point—right? Wrong. While the benefits are incontestable (less costly, more patient-friendly, easier recruitment and better data quality), we are still in the early adopter stages. How could this be so as we already approach year 2020?
Recently Josh Rose, VP R&D Global Strategy and Head of Virtual Trial Solutions at global CRO giant IQVIA (Quintiles), addressed this important topic in the publication Contract Pharma. Mr. Rose has some credibility in this topic as he is leading the virtual trials group for the world’s largest contract research organization (CRO). Rose notes the standard reasons as to why important technological advances don’t move faster in conservative industries such as healthcare and life sciences, including the well-known culprits of compliance and regulations to rigid policies and procedures based on siloed departments.
Complexity lies at the heart of the matter
Rose educates the audience that clinical trials are an incredibly complex affair—requiring not only processes, policies and systems/tools but also a complex divisions of labor often involving many departments, disciplines and knowledge domains—all spanning the globe. Identification of the technology elements of virtual trials—from telehealth to mobile technology to cloud computing—isn’t the hard part. The appropriate redesign of clinical trials to operate differently involves multiple platforms, devices, and software with different data capture paradigms that represent generally established processes, workflows and standards. Successful mobilization of virtual trials requires that they are infused seamlessly into the design of data capture, management and reporting flows that not only offers seamless integration but also customization to “accommodate the idiosyncrasies of that trial’s protocols, patient abilities and investigator needs.” With new technology and processes comes new quality considerations, training and validation for FDA (and other authority) compliance purposes. Patient safety is serious business in drug development.
Models and the Future
Mr. Rose predicts that presently most virtual trials will follow a “hybrid model” while pure 100% virtual trials represent more of an “ideal state” from the perspective of efficiency, data quality, and cost effectiveness. A hybrid model includes virtual technology, so some of the study’s elements will be virtual—e.g. some of the monitors visits will be conducted remotely while there will still be some on-site visits.
Rose predicts 40% of new clinical trials will have some virtual elements (telemedicine, home health visits, online surveys and questionnaires, etc.) by 2022. Rose suggests sponsors start incorporating virtual as part of protocol planning as this isn’t about technology for technology sake but rather a fundamentally different way for how to not only conduct the trial but also how to facilitate more dynamic, real time engagement with patients and clinical investigational sites. Executive sponsorship in any organization is key, so undoubtedly learning how to not only infuse protocol planning with virtual components but also how to draft a compelling business case becomes as important as the technology itself.
Rose reminds the reader that business cases must include meaningful and measurable goals and objectives—how else can executives sign off? He reminds us that no two trials are 100% alike. They all have unique elements and hence each new trial design necessitates a tailored, well-thought out approach—be open minded, creative yet pragmatic and don’t forget painful lessons learned.
But do push the envelop and make it happen. There is a lot of CYA out there, especially in big biopharma and those that ultimately progress in the organization make bold but calculated bets to improve outcomes. TrialSite News has found that many executives want fresh, bold forward thinking that translates into calculated execution for materially improved results. The politics somehow becomes infused into the process and by the time programs, stakeholder committees and workstreams are formed and underway the spirit and nature of what the original idea was may have changed. It is very key to call out these train wrecks before they occur.
Call to Action: Virtual clinical trials are a fascinating subject and we recommend reaching out to Josh Rose.