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Navigating the Complexity of Virtual Clinical Trials
- 1. NAVIGATING THE COMPLEXITY OF ADOPTING VIRTUAL CLINICAL TRIALS Emily Kunka Digital Business Transformation Lead, UCB Michelle Luo Head of Global Evidence and Outcomes, Gastroenterology, Data Science Institute, Takeda
- 2. The views we share here are ours, based upon our own experience in several business settings and do not represent the views of our current employers. We are admittedly biased and passionate about this burgeoning field. DISCLAIMER
- 3. OBJECTIVES ● Understand the complexity of building virtual trial capabilities ● Recognize and adapt to the challenge of navigating multiple stakeholders ● Evaluate vendor capabilities for partnering in DCTs
- 4. Understand the complexity of building virtual trial capabilities
- 5. SPECTRUM OF COMPLEXITY Electronic Patient Reported Outcome [ePRO] Questionnaires and eDiaries Electronic Consent (eConsent) Smart Mobile Devices Used by Mobile Nurses Performance Outcomes [PerfOs] (ie. 6MWT) REMOTE ASSESSMENTS ClinROs by Investigator over Telemedicine or with Mobile Nurse as rater Patients’ Passive Use of Smart Devices (ie. Wearables) In-home sample collection and pre-processing IN-HOME ASSESSMENTS Patient Active Use of Devices with Active Tasks Sample Collection at Local Labs
- 6. PATIENT EXPERIENCE DESIGN WHAT WHO Is present during the study visits (SC, MRN, PI)? Is appropriate to do within the home? In what order? What can be shipped direct- to-patient? WHERE Should assessment take place within the home (ie. bed, hallway, near window)? HOW Are assessments completed within the home (ie. methodology and equipment needed)?
- 7. KEY CONSIDERATIONS 03 01 02 04 ASSESSMENTS What assessments have been done remotely before? Have they been validated? VENDORS What services do vendors (ie. mobile nursing, platform, device) have to offer? DEVICES What is commercially available? 510k cleared? Available for researchers? How do they work, integrate with the selected platform? LABS Sample processing requirements (Incubation, refrigerated centrifugation) Sample
- 8. Recognize and adapt to navigating multiple stakeholders
- 9. STAKEHOLDER MAPPING √√INTERNAL ● Executive Leadership ● Clinical Development Team ○ Clinical Science ○ Regulatory ○ Clinical Operations ○ Data Analysis/Stats ● Digital Transformation/Device/IT ● Real World Data/Outcomes Research ● Patient Engagement ● Legal ● Procurement EXTERNAL ● CRO ● Brick and Mortar Sites Investigators and Staff ● Patients/Caregivers ● Regulatory Agencies ● Vendors ○ Virtual trial site vendors ○ Telemedicine vendors ○ Central and Local Labs ○ Mobile nursing/home health vendors ○ ePRO vendors
- 10. INVESTMENT ● Up front costs for infrastructure ● Time required for new trial designs ● Uncertainty for regulatory pathway DATA ● Perceived lack of scientific rigor ● Data linkages, privacy, and rights ● Security and data residency (ie. GDPR) ● Data volume and analysis TECHNOLOGY ● Limited usability/reliability testing ● Access to new technology/devices ● User training for new technologies STAKEHOLDER CHALLENGES
- 11. CHANGE MANAGEMENT Set Organization Priority Engage Right Partners Demystify Virtual Trials
- 12. BUILD PROCESS MAP Build Use Cases & Playbook Step 2 Form Core Driving Force Step 1 Conduct Trainings Step 3
- 13. Evaluate vendor capabilities for partnering in DCTs
- 14. STATUS QUO Traditional CRO Specialized Vendors Investigator Selection eCOA (ie. ERT, Kayentis) Site Training eConsent (ie. ClinConsent) Study Monitoring eSource (ie. Clinical Ink) Participant Compensation EDC (ie. Medidata) Recruitment Strategy IRT (ie. Endpoint) Data Management Home Health (ie. MRN) Vendor Management Telemedicine (ie. AmWell) Device Management Direct-to-Patient Shipments Medical Writing Drug Supply (ie. Marken)
- 15. EMERGING DCT VENDORS Investigator Selection eCOA Site Training eConsent Study Monitoring eSource Participant Compensation EDC Recruitment Strategy IRT Data Management Home Health Vendor Management Telemedicine Device Management Direct-to-Patient Shipments Medical Writing Drug Supply
- 16. FLUID ROLES & RESPONSIBILITIES CRO VENDORS VIRTUAL TRIAL PLATFORM + SERVICE COMPANIES SITE
- 18. Discussion
- 19. What makes a trial more suitable for operationalizing in a virtual setting? Is there low hanging fruit?
- 20. How might we design DCTs in a way that we are collecting and evaluating patient experience and feedback?
- 21. How has the DCT implementation landscape fundamentally changed?
- 22. Are there differences in the appetite for and adoption of DCTs across geographies? How might we harmonize these differences and adjust attitudes?
- 23. Why should companies invest in virtual trials now?
- 24. Given the complexity of building virtual trials, will small or mid-sized companies be able to adopt them?
- 25. How do we plan for the future?
- 26. CREDITS: This presentation template was created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik. THANKS! Copyright Emily Kunka and Michelle Luo 2020. All rights reserved
Notes de l'éditeur
- EMILY: Hello and welcome to Navigating the complexity of adopting virtual clinical trials my name is Emily Kunka and I have the privilege of working for UCB in Digital Business Transformation. I’ve had the pleasure of partnering with and getting to know Michelle Luo over the last several months who is Head of Global Evidence and Outcomes at Takeda where she also currently leads a virtual clinical trial think tank. Both of us have complementary experience in the area of virtual clinical trials, but from differing perspectives-- myself mainly from designing and operationalizing virtual trials and Michelle from a change management and implementation perspective. I believe that we can tackle and explore challenging areas more deeply if we gain a more holistic perspective and that is what we hope to offer here today. Before we get started I wanted to take a minute to give a bit of a disclaimer that the views we share here today are ours, based upon our own experience in several business settings and do not represent the views of our current employers. We are admittedly biased and passionate about this burgeoning field. I have to be honest with you all that the early days of this work, pre-COVID, was arduous largely due to the fact that telemedicine was not widely in practice, so if there is any silver lining to this pandemic it’s that this work is not only fun and exciting and challenging but NECESSARY as we evolve into imagining what a post COVID world looks like. So if there’s anything you take away from the conversation today it’s my hope that it’s greater optimism that some of the obstacles we initially faced in a pre-COVID world have been tempered, if not removed, over the last 8 months as more and more research professionals see the value of advancing this approach.
- EMILY: Michelle and I plan to cover the following three objectives today...
- EMILY: Starting with the first objective...
- EMILY: I’d like to start by candidly saying that when I saw the title of this conference I wondered about the use of the word “virtual”. The importance of terminology cannot be understated and for many years the neural pathways in my brain have been trained to use the acronym DCT meaning decentralized clinical trials, and for good reason, which I hope this slide will illustrate. Decentralized trials come in a variety of flavors, and there is a spectrum of implementing components of remote and in home assessments which are of varying difficulty. On the left hand side you’ll see items we’ve been doing for years like eConsent and ePROs which are “less controversial”, more “passive”, and straightforward if you will. But as you move towards the right hand side, things start to get a bit less standardized and more “active” with a greater need for planning, coordinating, and training. Assessments get gradually more complex for all people involved (both the study team and the patient) as you move from left to right. When I think of the phrase “virtual clinical trial”, I think of a trial at the far right end of this spectrum, but in reality, very few studies are entirely virtual these days. Most people are still navigating their way through hybrid trials, at best, seeing how they can move the needle from the left side of the screen to the right. It is not an easy process-- and one’s ability to move from left to right is iterative in nature and largely depends on a whole host of factors. So to step off of my soap box, I personally prefer the term DCT and think that that is a more accurate term which reflects where we are as an industry. This approach is still in its infancy and collectively we’re all charting the course for how to do this. It’s certainly not a one size fits all approach.
- EMILY: So one of the most exciting parts about the shift that is happening to DCTs is the fact that it allows us to mesh the best of several worlds-- medical science, technology, and design. We are finally waking up to the fact that if patients are our end users than we need their feedback and insights earlier in the development process, and their feedback MATTERS. Not only are we looking at more endpoints that matter to patients but we are also charged with creating trial experiences which better respond to patient’s needs. So to that end, when thinking about designing DCTs we need to consider patient experience design if we’re going to do things right. [read slide]
- EMILY: There are a lot of “behind the scenes” decisions that need to be made in order to optimize workflow, patient experience, communication, and increase the likelihood of trial success. So as we go to apply a DCT model to clinical study design there are many considerations needed, but I’ve outlined 4 key areas here. 1- [read slide] Are there new assessments to pilot for exploratory endpoints which may be better than the gold standard? 2- [read slide] We’ll get into this more in the latter part of this presentation 3- [read slide] Where is the device being deployed? Do they require a CE mark? If there is not a CE mark, what is the documentation required to satisfy ethics committees or import requirements for customs clearance? 4- [read slide] We need to think about sample turnaround time and viability. I’ve heard stories of mobile nurses centrifuging samples in their car -- so we need to clear define what practices are appropriate. How do we create and remove a “clinical space” within the patient’s home without all of the equipment we’re accustomed to having? Can we use a wet ice bath instead of refrigerated centrifugation? Can we minimize the amount of workarounds that are required? The phrase “thinking outside the box” is often trite, but it is so applicable and needed here. Oftentimes we have to get creative. With that I’ll turn the floor over to Michelle to speak about navigating what I call the “stakeholder forest” once you have a solid protocol design and operational plan for a DCT study in place. Michelle...
- MICHELLE: thanks Emily for giving an overview of the complexity of decentralized trial design, I am going to continue to share with you about recognizing and adapting multiple stakeholders. Although over the last few months, we have seen more and more clinics started to offer telemedicine or remote care, the overall adoption of virtual trials has been slow across the pharmaceutical industry. Why, because this is an uncharted territory, and many decision makers need to be brought on board.
- MICHELLE: From an internal perspective of an pharmaceutical company, you will have typical players centered around clinical development teams to start look into a new design of virtual trials typically hybrid trials, but some new players also need to be at the table, including digital transformation, device and IT, in order to evaluate opportunities and feasibilities for collecting digital biomakers and remote data collection. Externally, we can’t rely on only the CRO partners to work with brick and mortar study sites, we need to evalaute and engage new set of partners , such as telemedicine vendors, virtual trial site vendors, and mobile nursing and home health vendors, which will provide decentralized services and offer more flexibility for patients and caregivers to participate trials at their home or places convenient to them.
- MICHELLE: Clinical trials have been conducted for over 200 years (first one in 1747 by James Lind), with the sudden disruption by COVID pandemic, the industry has been forced to make changes to keep drug development on track. There are a lot of challenges, some are real some might be perceived. In general, there are 3 categories of challenges, investment, data and technology. I would like to highlight for you the data challenges, (Read slide)
- MICHELLE: We have realized that we need to Think Different, and implement change management. Demystify virtual trials: this starts with education, both internally and externally. Internally, we need people to understand the risk/benefit ratio. Externally, we need to cultivate a scientific community with early adopters which will champion and pave the way for others to come. Set organization priorities: Up front investment for infrastructure, build time required for new trial designs, engage early with regulatory agencies for new regulatory pathways Engage right partners: We must support the efforts that lead to the development of new technologies, devices, and measurements as part of modern patient care. We can’t sit back and wait for this to happen on its own. We need to create a sense of urgency.
- MICHELLE: Where do we start? We need to start now with front loading investments, so that we can realize the ultimate goal of reducing trial burden on patients. All the while, simultaneously optimizing trial outcomes. We can start small with piloting on one or two trials to form the core driving force within the company, building use cases that can share as best practices as well as lessons learned. However, to scale this, we need to build process maps and playbooks that we can later on use to train and socialize with others at the enterprise level.
- EMILY: When we are scaling, we are not doing this alone. It is important to really evaluate and select the right vendor and take the journey together.
- EMILY: The tired, old story of traditional pharma working with the traditional CROs and specialized vendors is changing. I’ve provided examples of these “specialized vendor” companies here, and there are many today that you might have heard of. And I’m sure there will be more to come! These companies typically do one thing and do it well, which has also served us well up until this point, but segmented services and can lead to a disjointed approach to implementing a DCT model. We are seeing that the gaps are being filled with emerging vendors who saw opportunity in this segmentation and have been very successful in doing so...
- EMILY: In the spirit of offering a more integrated and comprehensive solution to DCTs, emerging DCT vendors are starting to appear. You’ll note that the items in pink here are the same items from the previous slide that traditional CROs and specialized vendors continue to offer that these new emerging DCT vendors are now offering together. Only a few services, noted in here white, remain as territory left to be commandeered. They offer a suite of services which combine the capabilities of the specialized vendors which allows for greater customization of trial services with a technology backbone. I’ll say it here and I think Michelle will say it again later, but we need to match the study design to the services that the emerging DCT vendor companies are offering and it’s becoming more and more possible to do so now that these lists of services are constantly growing and expanding.
- EMILY: Because these emerging DCT vendors are taking on so many more responsibilities that were traditionally held by others (site/CROs/specialized vendors) no one quite knows how to define them and they can be a bit of a chameleon. From my experience, they tend to be more agile and diversify themselves quite well to be more marketable to whomever they’re working with. They can also be different things to different people depending on the needs of the trial and trial sponsor. So their identity-- who they are and what they do--- on a project level has ended up being very dependent on the circumstances they’re in to allow for greater customization. While in a completely virtual study they may be a site, in hybrid study they may play the role of more of a vendor or CRO. It all just depends-- so when selecting partners you need to fully understand their services and we cannot put them in a proverbial box.
- MICHELLE: We need to match the partner and services they offer to the study design itself. Phase IV trials may be more reliant upon DCT companies that have a solid platform with bring your own device (or BYOD) and global capabilities who are stronger on the tech side. In a phase II or III the focus may be more on the comprehensive suite of clinical offerings/disease/patient experience, especially looking at vendors that are willing to co-develop more patient-friendly Clinical Outcome Assessments that can be performed within the home. We also need to consider what kind of trials the vendor has done before-- what is their geographic presence? How quickly can they mobilize local resources? What is their reputation? Have they been easy to work with? Have they been successful? Is there a potential for the partnership to grow and scale (especially when considering a phase II trial if there is a potential for a future phase III). I cannot overstate the importance of making the right decision in partnership selection and it’s critical to align key stakeholders on that decision. So what you see here are some areas that may tip the scale in one direction or another when evaluating a potential partner. Some bubbles might be more relevant than others, depending on your use case. The right criteria for selection should be established early on and should be fit-for-purpose.
- MICHELLE: To wrap up, today we talked about navigating the complexity of adopting virtual clinical trials. We’d like to transition to a time of discussion between Emily and myself to keep things a bit more interesting and fun. So we’ve selected some thought-provoking questions which we hope will pique your interest and get the wheels turning a bit more for you.
- MICHELLE: [asks question] EMILY: I believe certain therapeutic areas are a better fit than others simply due to the type and frequency of assessments they require. Dermatology is squarely one of those TAs-- it is simply easier to visualize the skin over telemedicine moreso than say oncology. Also, study phase is very important. Phase II trials by being smaller, for example, are easier to work with than large phase IIIs. I have yet to see a phase I DCT-- if anyone knows of one that exists please let me know, but I have largely seen that there is no opportunity for DCTs in phase Is due to the more intense focus on long hospital stays for PK sampling. My answer to the low hanging fruit question is phase IV trials as they tend to be lower touch and more direct-to-patient. There’s a greater opportunity for more real time/real world data collection which uses the existing tools that patients already have at their fingertips-- their smartphone/smart watch/ and in-home virtual assistants like Amazon Alexa. There is less “manpower” and resourcing oftentimes required for these types of trials as data collection and quality standards are less rigorous with “free-living” patients. Lastly, I’d say that IP administration route has also bubbled up to be an important determinant for DCT viability. Oral or injectable drug studies are easier to implement than infusion studies for obvious reasons. Infusion studies oftentimes require a crash cart nearby for infusion reaction and that is just not practical within a patient’s home.
- EMILY: [asks question] MICHELLE: feedback should be timely and given right after the visit in an anonymized way, should also collect patient feedback on the protocol prior to studies in a patient roundtable with advocacy group involvement in parallel to tease out insights. Feedback could also be gleaned from the study team and mobile nurses throughout the study (not just at the end). Need to understand patients needs. If have elderly patients, may prefer to go into the clinic. Patients who are parents and have kids may prefer the home health.
- MICHELLE: [asks question] EMILY:. Over the years we have seen more and more players on the scene, with an expanding number of options to choose from. As we alluded to earlier, we are seeing new tech vendors now in competition with traditional CROs and it can be a bit of a crowded space. But that competition is good-- it is driving folks to re-define value for both businesses and patients alike.
- EMILY: [asks question] MICHELLE: Yes, get them greater exposure, practice opportunities to have immersion in/experience what participation might look like as a patient. Simulation activities can be helpful for people within these companies to see what it would be like to be a patient or a user of the platform. US FDA commitment/open to DCTs, issuing guidance to keep drug development going during COVID, active exploration and collaboration for adopting, “open science” “pre-competive sharing” EU EMA Catching up from a policy perspective, no concrete guidelines, country by country approach is necessary as there are inconsistencies in adoption of home health and physician supervision of telemedicine assessments, need to encourage a more open environment for policy development, data privacy (GDPR) and cybersecurity are hot topics.
- MICHELLE: [asks question] EMILY: As we move into a post-COVID era, more companies are adopting these technologies and we can feel the environment shifting. The fact of the matter is, whether people like it or not, these changes we’ve had to implement in healthcare as a result of COVID are here to stay. I love analogies, so I think of it this way-- the genie is out of the bottle at this point and it cannot be put back inside. There was sort of an inflection point when COVID started which propelled us at top speed to adopt telemedicine almost overnight. I truly believe we have the momentum at this point to move beyond purely digitalizing existing processes and ways of working and rather transforming how we think and act. For years we discounted the average patient as disengaged, when in fact, we never gave them the opportunity to be engaged to begin with. So we’re seeing this mind-meld now where sponsors are directly connecting with patients and intermediaries of information are dwindling away as the voice of the patient is getting louder and clearer. And these are all good things-- we are breaking down barriers and better listening to patients to find solutions that work for everyone involved. With investment comes insight and insight is valuable. I’m speaking about newly created, unique value which allows companies to better understand, and thus better tackle, the problems facing the patients they serve.
- EMILY: [asks question] MICHELLE: Bigger companies have resources up front to build the infrastructure and bring in a lot of players and layers to engage. On other hand small/mid-sized companies can be very focused and they can build partnerships and move quicker with emerging tech companies and have the mentality to be more agile for trying new things and taking more risks. Smaller companies can explore cost-sharing and are more likely to explore new use cases.
- MICHELLE: [asks question] EMILY: A critical mass is needed to drive this era of virtual forward. We need to create an ecosystem of shared resources, experiences, and learnings like we are doing today. We also need to pay attention to medical futurists and science fiction -- historically cartoons like the Jetsons and movies like Star Trek have jogged the imagination. I’ll share that Bertalan Meskó is my favorite medical futurist. Needless to say, we need to tinker, try, and sometimes even fail. And as cheesy as it sounds, we need to see failure as an opportunity to learn and improve. I wanted to leave you all with a quote from the spanish poet Jose Bergamin who wrote, “To be ready to fail, is to be prepared for success.” I think that perfectly sums up our mandate moving forward. MICHELLE: Future starts now. We cannot wait or plan perfectly. Need action now. Learn from doing. With that we have about XX time for questions from the audience. OR It looks like we’re out of time. We’ve enjoyed being with you and thank you for your time.