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Innovation in Clinical Trials

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85% of clinical trials fail to recruit enough patients, 80% fail to finish on time. A key issue is 70% of patients live more that 2 hours from the study site. Wearable devices can support the collection of real world data in the patients home as well as create novel endpoints

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Innovation in Clinical Trials

  1. 1. Innovation in Clinical Trials Are wearables the answer to the issues facing clinical trials? Gary Monk February 19th
  2. 2. Clinical Trials are plagued by under recruitment, delays and dropouts. One key barrier is participants distance from trial sites 85% Of clinical trials fail to recruit enough patients1 80% Of all clinical studies fail to finish on time1 (& 20% delayed for 6 months or more) 30% Is the average dropout rate of all clinical trials1 Sources: 1) ClinicalLeader.Com 2) FierceBiotech Of potential participants live over 2 hours away from the study site2 70% @garymonk
  3. 3. It is not only Geography: There are barriers across each stage from Identification to Retention Identify Engage Enroll Retain Barriers at Each Stage Often the right patients can’t be identified and reached in the first place. Social Media is a great tool for this but only 11% of trials use Social Media to reach potential patients Once the patient is reached they are often not engaged in the right way, i.e. quickly with clear benefits for participation & enrolment made simpler The key barrier to participation in a trial is geography, i.e. distance of patients home to trial sites Geography remains an issue with patients tiring of follow up visits. An important insight is the patient needs to see benefits for their continued participation. Simplicity and convenience alone do not cut it Sources: 1) AppliedClinicalTrialsOnline @garymonk
  4. 4. Trials that use wearable technology & sensors to monitor patients at home, solve the issue of distance & improve the patient experience Potential Benefits of Wearables in Clinical Trials Increased and faster recruitment (patients don’t have to travel to centers) Higher compliance rate > Easier for patients particularly where wearables collect passive data Reduced dropout rate, remote monitoring via devices = < hospital visits The large amount of additional data could mean a lower variability, so fewer subjects could be needed to achieve statistical power In addition the creation of Novel endpoints, e.g. mobility as a measure of QoL, extended sleep monitoring @garymonk
  5. 5. Before we get too excited, there are downsides, at least at the moment…. Potential Issues of Wearables in Clinical Trials New Processes Huge volumes of data need new techniques for storing, processing and analyzing New Skills Clinical teams not familiar with collecting and analyzing large data sets Standardization Lack of industry standards for devices in terms of terminology data processing Data Privacy Data ownership and sharing, consent requirements and the variability of these laws across geographies Data Security Particularly important for patients in a clinical trial setting @garymonk
  6. 6. The Number of Digital Health trials using Wearables to capture patient data is increasing year on year 8 16 26 45 61 95 125 162 0 180 2011 2012 2013 2014 2015 2016 2017 2018 The number of trials using wearables starting in given year In 2019, 52 ‘wearable’ trials are already underway or scheduled, suggesting a sharp future increase Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk
  7. 7. Despite this increase a very small number of clinical trials are using or have used wearables & Pharma are only just beginning to explore 604296,960 29 Total Trials Trials using Wearables Pharma Trials using Wearables 0.2% 0.01% Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk
  8. 8. 23 Pharma companies have experience in wearable clinical trials. The majority with only 1 trial 4 Trials (1) 2 Trials (5) 1 Trial (17) Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk Note: 2 partnership trials. GSK/Gilead and Lundbeck/Otsuka
  9. 9. Digital Health studies cover a significant breadth of conditions Source: ClinicalTrials.Gov extracted 2/9/19 Disease Area # of Trials Companies Active HIV 3 Gilead / GSK Parkinsons Disease 3 Abbot/Biogen/UCB Rare Disease 3 Actelion/Bayer/Theravance Schizoprenia/Bipolar/MDD 3 Lundbeck / Otsuka/ Takeda Dermatology 2 LEO / Pfizer Diabetes 2 Eli Lilly Heart Failure 2 Novartis / Precigen Pain Management 2 Mudipharma / Purdue Angina 1 Gilead Autism 1 Roche Cancer 1 Genentech COPD / Asthma 1 GSK Growth Hormone Deficiency 1 Pfizer Hemophilia 1 Bayer Kidney Disease 1 ZS Pharma Migraine 1 Allergan Stroke 1 Janssen @garymonk
  10. 10. Where wearables are used to capture patient data the US dominates. Canada, Israel & UK are strong ‘runners up’ 351 35 33 32 16 15 14 13 12 9 US Canada Israel UK South Korea Italy France Switzerland Germany Belgium Top 10 Countries using Wearables in clinical trials (all time # of trials) Total # of Trials Trials per million population US Canada Israel UK S Korea Italy France Switzerland Germany Belgium 1 2 3 4 5 76 8 9 10 Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk 1.1 1.0 3.8 0.5 0.3 0.25 1.5 0.15 0.8 0.2
  11. 11. Key Takeaways @garymonk • Clinical Trials have number of critical issues around recruitment & retention • Geography is a big issue (patients distance from Trial Sites) that wearable technology can help solve, by allowing clinical data to be captured in the patients home • Trials using wearables are increasing year-on-year but only represent a small number of all trials (0.2%) • Pharma only limited involvement in trials using wearables (ca. 30) with 23 companies active across a broad range of therapy areas
  12. 12. Notes: @garymonk • ClinicalTrials.gov is a comprehensive source but may not be an exhaustive list of ALL wearable tech trials • This research was based on wearable devices, other Digital Health trials exist, e.g. using remote sensors, smart devices (e.g. inhalers) that are not included here. These numbers are also small
  13. 13. Feel free to connect! @garymonk @garymonk linkedin.com/in/garywmonk/

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