Welcome: Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote - PowerPoint Presentation

1. Welcome: Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote & Virtual VisitsThis webinar is being recorded and will be posted to the CTTI websiteAll participants are muted upon entryQuestions can be entered in the chat box during the webinar Questions will be addressed after the call via CTTI’s best practices document

2. AgendaIntroduction Pamela Tenaerts, CTTIOpening Comments Jacqueline Corrigan-Curay, FDA, CDERCTTI Survey & Best Practices Lindsay Kehoe, CTTIPerspectivesFrom Sponsors: Laura Cooke, AmgenFrom Sites: Ramya Thota, Intermountain Health, ASCOFrom Participants: Bray Patrick-Lake, Evidation HealthSummary Pamela Tenaerts, CTTI

3. Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote & Virtual VisitsThe views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of the Clinical Trials Transformation Initiative.May, 20, 2020

4. IntroductionPamela TenaertsCTTI@PamelaTenaerts

5. Multi-stakeholder,public-private partnershipco-founded by Duke University & FDA Participation of 500+ more orgs and + 80 member organizationsMISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials

6. Addressing the COVID-19 PandemicCompleted WorkConduct of ongoing trials in COVIDDesigning high-quality COVID treatment trialsDaily download of COVID clinical trials During the PandemicSwitching to remote/virtual visitsMaster ProtocolsDiversity issuesRoundtable focused on getting to well-powered clinical trials Highlight members contributions to solving COVID issues After the PandemicLessons learned & maintaining the transformationContingency planningAnalysis how clinical trials ecosystem changed due to pandemic

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8. Limitation of Technology

9. Opening CommentsJacqueline Corrigan-CurayFDA, CDER 

10. Best Practices & Challenges in Switching to Remote and Virtual VisitsLindsay KehoeCTTI

11. Experiences Switching to Remote or Virtual VisitsCTTI collected feedback from April 29 - May 7 Distribution:Email to CTTI member organizations & public contactsPosts on Twitter & LinkedInEncouraged trade, media, & other organizations to shareWe askedDo you have a best practice or successful example of transitioning to the use of telehealth in a clinical trial? What have you tried? Have you experienced any challenges in transitioning to the use of telehealth in a clinical trial? Is there anything else you would like to share?

12. Respondents (n=62) Pharma, 10Patient Group, 3Academia, 14Technology, 7Device/Diagnostics, 3Gov,1Investigator/Site, 11Other, 2CRO, 9Biotech,2

13. How Visits Transitioned to Remote/Virtual Google MeetsZoomPhoneWhatsAppSkype85% of respondents transitioned to remote/virtual visits in > 1 ongoing trials Team Microsoft Box

14. The Parts of Pre-Pandemic Site Visits that Transitioned to Remote/Virtual

15. Mid-Pandemic Hurdles in Switching to Remote/VirtualAs conveyed by 57% of respondentsAssessmentsStatistics implicationChoice (licenses & contracts, no best standard)Ease of use & Adoption (participants & sites)Limited access to telehealth platforms pre-pandemicReimbursement for remote/virtual visitsLocal: Laws & regulations, licensing, contractsQuality (unknown) & availability (clinical care)Cannot do every assessmentHow to get to participantsHow to administer if IVSites = short staffed & working from home, schedulingRisk based monitoring

16. Best Practices & Words of WisdomAs conveyed by 50% of respondents

17. Sponsor PerspectiveLaura CookeAmgen@cookelaurac

18. Continuous Trial by Trial Assessment of Patient Safety & Data Integrity Leverage analytics Supported by ongoing assessments Statistical impacts:Missing assessments, missed doses, remote vs onsite visitRegulatory guidance updatesRemote SDV, TelehealthLocal insights

19. Imagining a ‘New Normal’ for Clinical Trial VisitsPre-COVID-19: Site based visits & carePossibilities: Home based visits & care

20. Consider the Objectives for Remote/Virtual Visits

21. Study Specific Telehealth Application

22. Implementation Considerations

23. Site PerspectiveRamya ThotaIntermountain Healthcare ASCO Research Community Forum@ramyathota1

24. IntroductionImpact of COVID-19 based on site and geographic locationBenefits of remote and/or virtual visits to participants and sitesShare insights from ASCO survey of clinical trial sites Site perspective on site–participant interactionsSite perspective on site–sponsor and site-CRO interactionsFuture directions to transform clinical trials

25. Impact on Clinical Trial Sites

26. Benefits of Remote and/or Virtual Visits to Participants and Sites

27. Site ConsiderationsWork has changed:Working from home Learning new technology and adapting to a new practiceIncreased workload on research staff with limited resourcesIncreased administrative and regulatory burdenLimited ancillary services Radiology, surgery, cardiology, laboratories, etc.Developing new SOPs to endure sponsor requirements metTrials have changed:Decreased enrollment Decrease in patient ability or willingness to come to sitePrioritization for therapeutic trials that benefit patientsSite sustainability has changed:Concerns for financial sustainability of research programs

28. Strategies for Site–Participant InteractionOngoing studies: Virtual (audio/video) or remote visits from alternate siteRemote lab collections/assessments at nearby facilities or mobile labs Drug shipments (oral) directly to patientsIV drug administration closer to homeElectronic completion of PRO, QOL, other questionnairesResearch-only visits halted, except for those on active treatmentMinimize unnecessary research only blood draws or biopsiesNew studies:Remote screening by coordinators working from homeRemote consenting (or e-consenting) when feasiblePrioritization of COVID-19 trials over non-COVID

29. Challenges with Site–Participant InteractionsRemote or virtual visits are not always ideal - consider:PatientClinical circumstanceHealthcare providerTraining on software and digital tools - patients, physicians, staffLogistics (scheduling, follow-up)Communication is keyIncreased documentation – administrative and regulatory burdenTechnology – access and reliability issuesTime-intensive

30. Site–Sponsor and CRO InteractionsConsiderations Remote site initiation visitsRemote monitoringRemote pre-study site visits for new trialsFlexibility with visit completionsSimplified process less burdensomeOverall flexibility from industry sponsors and CROs - not punitiveCommunication that is inefficient, duplicative, inconsistent, and conflictingEvery amendment requires IRB submissionLack of standardization Holds on study enrollmentTime to upload source documents for remote monitoringInsufficient compensation for remote workChallenges

31. “Cancer didn’t quit because of COVID-19 and neither should research”Long-term opportunities to transform clinical trialsMore pragmatic and streamlined trial designs and operationsFewer clinical trial-related patient visitsMinimize sponsor and CRO visitsSpecial attention needs to be given to patient concerns and needsAccess to treatment Availability of trials, availability of drugs, risks, financial toxicityComfort and confidence Safety of trials and drugs, ability/willingness to travelSituation needs continuous monitoring to address patient and program needs“We now know that things deemed never possible are possible to do.”Research Must Continue!

32. Participant PerspectiveBray Patrick-Lake Evidation Health@BrayPatrickLake

33. Communications received from sites and study teamsUnderstand and evaluate individuals’ overall experience with communication with site about the pandemic and the impacts to the trialDifferences between participation experience before and after the pandemicUnderstand how the pandemic has changed participations’ experience before and after the pandemic started by specific therapy areas and minority individuals Status and perceptions of risks & benefits of participantsUnderstand the status of clinical trials and how it has impacted the perceptions of participants Collaboration between Evidation Health and CTTI to understand how participants currently enrolled in clinical trials have been impacted by the COVID-19 pandemic 123

34. 16,000 rapid identifications of potential trial participants during survey design phase12,000 + survey responses were collected from 5/8/20 - 5/11/20 Through our ongoing relationship with Evidation’s Achievement community, we surveyed participants in various therapy areas who are currently enrolled in a clinical trial (N=848) Enrolled in a clinical trialResponses 12,36511,517 848DisqualifiedFocus of this presentationObservational study participants exited out

35. Demographics Age distribution N = 848The following conditions were represented in the survey responses: COVID-19, Oncology, Cardiology, Neurology, Nephrology, Pulmonary/Respiratory, Infectious Disease, Orthopedics, Dermatology, Rheumatology, Ophthalmology, Endocrinology, Hematology, Gastroenterology, Genitourinary, Psychiatry/Psychology, and OtherIncome distribution N = 84817% indicated a race or ethnicity other than White or Caucasian 33% annual household income less than 50K with 11% under 25K71% identify as female

36. The following conditions were represented in the survey responses Clinical trial primary therapy area distribution N = 848

37. Overall, 16% of individuals’ trials have been stopped and it will not start again; 16% of individuals’ trials have been delayed Status of current clinical trial N = 848N = 45N = 31N = 28N = 42N = 31N = 16N = 98*OVERALL: ACHIEVEMENT HEALTH PROFILE INCLUDES 17 THERAPY AREASN = 848

38. More than half of immunocompromised respondents worried about going to a hospital or clinic, but only 12.4% stopped trial for this reason35% of the 848 individuals reported feeling worried or very worried going to a hospital or clinic during the COVID-19 pandemic Of the 258 individuals who are immunocompromised, 52% reported feeling worried or very worried going to a hospital or clinic during the COVID-19 pandemic9% (77) overall reported stopping their participation in their clinical trial because they worried about being exposed to COVID-19Of the 258 individuals who are immunocompromised, 12.4% (32) reported stopping their participation in their clinical trial because they worried about being exposed to COVID-19N = 848N = 98N = 28N = 45N =31N = 31N = 42Individuals who stopped participating in their clinical trial because they were worried about being exposed to COVID-19 What do the stoppage rates by disease areas tell us about participant perceptions on risks vs benefits?N = 16*OVERALL: ACHIEVEMENT HEALTH PROFILE INCLUDES 17 THERAPY AREASN = 848

39. 14% (121) who had not stopped participating were thinking about stoppingReasons for wanting to stop or thinking about stopping participation in their clinical trial N = 198

40. 35% who had in-person visits before the pandemic now report spending less time going to research visits at sites or hospitalsN = 335 Individuals who spent more or less time on clinical trial activities after the pandemic, as compared to before the pandemicN = 257N = 252N = 272N = 274

41. Of the 335 participants who reported going to in-person visits to the research site or hospital before the pandemic the following activities were added:Clinical trial activities added after COVID-19 startedN = 335

42. 52% (175) who reported going to in-person visits to the research site or hospital before the pandemic experienced changes to their clinical trialN = 175N = 15N = 3N = 6N = 9N = 8N = 7N = 33Worsened or Improved Participation Experience after Trial Changes Were Made Overall*: ACHIEVEMENT HEALTH PROFILE INCLUDES 17 THERAPY AREASN = 175

43. (non-exhaustive list)Free text responses about how changes to the clinical trial after COVID-19 started improved or worsened participation experienceMy clinical trial involves a new device for birth control. Since the pandemic, in-person checkups have been postponed. This is better for me as I don’t have to spend that time in the clinic, but worse for the trial”Because the trial was put on hold, my heart function is getting weaker. If I was in the trial, I would have an inflatable device that would improve my heart function ”We are now being tested for COVID-19 which is an added benefit since testing is so rare”“““The interview part is now conducted over the phone and i pick up the medication curbside. It’s not a huge difference but it’s convenient”“It was paused but I believe it was paused by to not being close to other patients so that’s how it has changed. I go to the clinic one day a week and it’s been paused but I do continue taking some medicine and I get phone calls from the nurse”“Getting to the site with this pandemic makes me more worried of contacting COVID-19”“

44. Methods of communication and participant satisfaction with communications received91.5% Satisfied32.5% were somewhat satisfied and 59% were very satisfied8.4% Dissatisfied6.7% are somewhat dissatisfied and 1.7% are very dissatisfied Communication received from research site or investigator on impact of COVID-19 on one’s clinical trialN =762

45. (non-exhaustive list)Most commonly reportedLess commonly reportedDesire for some communication40% (17) of individuals indicated they wished they received some sort of communication, as they didn’t receive anyDesire for texts, emails, or calls to understand the impact 9% (4) of individuals expressed wanting information via text, email or phone to understand how COVID-19 would impact study plansDesire for statistics related to the trial 4.5% (2) of individuals reported wanting more info, videos and statistics about the trial Common themes on how communications could be improved as described by individuals who felt dissatisfied (8.4%)Any communication at all would have been great, there just wasn’t any”“It would have been nice to receive an email about how the study plans to address in-person visits during the pandemic”“They could have made a statement in the beginning regarding their new procedures/if there were any changes. I shouldn’t have had to reach out and then waited over two weeks for a response”“

46. Key takeaways 16% reported that trials had been stopped, 16% reported trials had been delayedOncology trials had the lowest stoppage while dermatology reported the highest amount of stoppage and delaysThe therapeutic area trends of sponsors or sites stopping trials were consistent with participants deciding to stop their trial participation due to worry over COVID-19Oncology - 3% stopped participatingDermatology - 26% stopped participating More than 1/3 of those who had in-person visits before the pandemic report traveling less frequently to sites or hospitals after COVID-19, 37% had telemedicine visits added And finally, communicate, communicate, communicate!

47. Thank you to CTTI for collaboration on study design and interpretation!Questions?bpatricklake@evidation.comlindsay.kehoe@duke.eduSpecial thanks to the project teamEvidationPriya Kumar - Lead Survey design, implementation, analysis, interpretationMegan Van Ostaeyen Participant engagement, QAVictoria Lo Participant engagement, QADave Samuelson InterpretationCTTIZach Hallinan Survey design, interpretationLindsay Kehoe Survey design, interpretation

48. Next stepsPost recorded webinar & slidesAdd today’s information to best practices documentAdditional COVID-related CTTI efforts are forthcoming

49. Lindsay.kehoe@duke.edu