Decentralized Clinical Trials In 2020: A Global Survey
Decentralized and Hybrid Trials 2020 Global research study into adoption and technologies 21 July 2020
Presenters Pharma Intelligence and Informa Connect Daniel Chancellor Director, Thought Leadership Pharma Intelligence LinkedIn informa | Pharma Intelligence 3
About Clinical Trials Europe 2-4 November 2020 Now delivered as a 100% Virtual Conference & Exhibition Join hundreds of clinical industry stakeholders online this November as Clinical Trials Europe 2020 moves to a virtual format. Bringing the latest innovations and developments in clinical partnerships, outsourcing, operations and technology to you, you will be able to get your questions answered and network with your peers with our fully interactive platform - all from the comfort of your own seat. Visit the website to find out more: informaconnect.com/clinical-trials-europe informa | Pharma Intelligence 4
Agenda Introduction and definitions • Decentralized and hybrid trials • Informa Connect and survey methodology • Clinical Trials Europe 2020 Key survey takeaways • Current adoption of DCTs • The COVID-19 effect • Digital technologies and perceived benefits • Challenges and barriers to adoption Decentralized trial trends • Regional perspectives • Therapy area views Conclusions 5
Introduction and definitions
“Decentralized clinical trials are defined as those executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model” Clinical Trials Transformation Initiative informa | Pharma Intelligence
Decentralized clinical trials Digital trial capabilities as a continuum rather than an absolute • Digital technologies and enablers are shifting the point Decentralized, virtual trials by start year* of care into the patient’s home 140 • The simplest of these are increasingly pervading 120 Number of trials “traditional” clinical trials 100 • 80 Decentralization of trials can be now seen as a 60 continuum 40 20 0 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Electronic Mobile clinics Telehealth YTD consent Patient- Wearables *Explicitly stated in trial description/notes/protocol reported Digital Hybrid Traditional Fully decentralized outcomes therapeutics J&J’s 2020 virtual trials Real-time tracking Heartline: Mobile app and Apple AI-ML Watch for stroke reduction augmentation CHIEF-HF: Invokana real-world study Source: Trialtrove; In Vivo informa | Pharma Intelligence 8
Informa Connect survey methodology Global survey of 180 clinical trial professionals In May 2020, Informa Connect surveyed clinical trial professionals on Organizations the adoption of DCT and technologies involved • Representation across wide range of organizations and stakeholders • Sample contains half European and one third US respondents CRO 33 • Broad therapeutic area coverage, with majority of respondents Tech provider indicating >1 area of focus Consultancy Service 12 provider Regions Areas of focus Investigator 10 site Oncology Europe Academic Cardiovascular 125 Patient group North America I&I Regulator Neurology Asia Respiratory CNS Middle East Infectious diseases South America Endocrine Pharma 18% Other Biotech 7% Africa Not applicable Medtech 6% Services 69% 0% 20% 40% 60% 0% 20% 40% 60% Source: Informa Connect informa | Pharma Intelligence 9
Key survey takeaways
Current DCT adoption Balancing on the cusp of mainstream clinical research Decentralized and virtual trials still Current trials featuring decentralized/virtual features represent the minority of clinical research 60% • Over three quarters of respondents report very little current use 48% 50% Proportion of responses* 42% • 42% A small number of specialists are 40% 40% incorporating virtual components into 35% 32% all studies 30% 20% Biopharma industry is generally lagging behind clinical service providers 10% 9% 9% 8% 8% 10% 6% 6% 4% 0% Weighted average suggests approx. one 0% 0% 1–30% 31–60% 61–99% 100% quarter of ongoing trials feature DCT components Average Industry Services • Likely overestimated, but nevertheless speaks to huge opportunity *Respondents indicating not applicable are removed from the analysis Source: Informa Connect informa | Pharma Intelligence 11
Immediate effect of COVID-19 COVID-19 is largely spurring on efforts to increase DCT adoption Clear consensus emerges that COVID-19 is Effect of COVID-19 on current DCT adoption necessitating acceleration of DCTs 3% • 76% suggest pandemic is leading to Industry 25% 73% increased DCT use among their workload • Both biopharma and service providers Services increasing emphasis on these technologies 8% 15% 78% as direct result 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Reduced use of DCT No impact Increased use of DCT Trialtrove notes more confirmed DCT starts in June 2020 than any other month on record “Where previously sponsors were reticent, they are now asking for some hybrid trial solutions.” “COVID is catalysing of our transformation process towards DCTs. All players in the “COVID-19 is placing additional demand for “It has pushed most of the data collection trials ecosystem must adapt to the new decentralized trials. Modifications for protocols to be done remotely, hence future trial situation and speed up the implementation to allow for more decentralized visits and the designs will be more robust to allow most of new procedures that vary from the need to de-couple some site based procedures procedures to be done virtually.” traditional clinical trial model.” to allow more visits to be remote.” Source: Informa Connect; Trialtrove informa | Pharma Intelligence 12
Longer-term effect of COVID-19 Inflection point creating lasting change in trial practices Over 9 out of 10 respondents expect COVID-19 to catalyze No impact, 4% Decrease, 5% increased adoption of DCT in the long term • Q: What impact do Further gains from 76% increase on current workload you think COVID-19 • No rebound once initial disruption of pandemic is over will have on the adoption of DCT • Sentiment equally expressed across organization type and across the industry in geography Increase, the long term? 91% Likelihood of increasing DCT within next two years Within individual organizations, adoption will likely 2% be variable, depending on immediate business needs Industry 4% 9% 40% 45% 2% Nevertheless, strong expectation that momentum Services 14% 38% 47% towards DCT will continue over next two years • 85% likely or certain to see increases 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% • Very unlikely Unlikely Neutral Likely Certain Just 4% indicating further adoption is unlikely Source: Informa Connect informa | Pharma Intelligence 13
DCT technologies Technologies that enable a point-of-care shift feature prominently Mobile technologies are clear enablers for the Technologies used in current DCTs shift of clinical trials into the home • Mobile technologies 77% Such technologies are harnessed in 77% of Wearables 60% current DCTs In-home devices 54% • Mobile technologies: eConsent, EHRs, wearables Sensors 35% • Mobile HCPs for assessment and treatment AI and ML 31% • Mobile phones: PROs, telemedicine, digital Tx Other 9% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Overlapping definitions, but all allow for Proportion of responses* *Respondents indicating increased mobility and reduced burden not applicable are removed from the analysis • Other, 6% Shared technology may also be across in- home devices, sensors and wearables Cost, 5% Reliability, Customization Q: What is the most AI-ML becoming more routine in trials 49% options, 14% important aspect to • Facilitates diagnosis, patient stratification consider when deciding and even evidence generation on technology? Ease of use, 26% Source: Informa Connect; CTTI informa | Pharma Intelligence 14
Benefits of DCTs Patient centricity is recognized as the biggest asset of a decentralized study Patient convenience and engagement is Main benefit for the adoption of DCT recognized as the leading benefit of DCTs • Half of respondents identified this Patient convenience and engagement 53% patient centricity as the main driver • Shorter trial timelines driven by Shorter trial timelines 13% biopharma R&D productivity demands More diverse/representative patient 11% DCT technologies can also be a double- populations edged sword… Reduced cost 10% NEJM patient engagement survey Most effective Physician contact Remote Real time data 8% time monitoring Shared decision Health plan Least effective making incentives Other 5% Access to services Medical information 0% 10% 20% 30% 40% 50% 60% Proportion of responses Source: Informa Connect; NEJM Catalyst informa | Pharma Intelligence 15
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