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Craig Elliott's Presentation at COS Conference 2017

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Patient Centric approaches to Clinical Trials:
Improving Patient Experience and Overall Study Quality

Published in: Healthcare
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Craig Elliott's Presentation at COS Conference 2017

  1. 1. Patient Centric approaches to Clinical Trials: Improving Patient Experience and Overall Study Quality Craig Elliott, PhD Global Head of Clinical Operations, Clintec International eCOS Brussels October 2017
  2. 2. Introduction • There is now increased competition for patients in Clinical Trials • The main challenge for clinical trials is to ensure that trials meet recruitment targets and ensure patient retention • The industry is now challenged to design protocols with the patients in mind whilst maintaining • scientific robustness, • valid outcomes and endpoints, • data integrity, and • compliance with international regulatory requirements.
  3. 3. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential According to the Tufts Center for the Study of Drug Development (CSDD), only 39% of sites achieve their enrolment targets, 37% fail to meet their targets and 11% fail to enrol a single subject into trials
  4. 4. Industry challenges The challenge for the pharmaceutical industry is can we design trials that: • Ensure the patient experience is positive • Are indicative of real world experience • Make best use of clinical trial technologies • Improve quality • Meet enrolment targets • Are truly risk based
  5. 5. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential FDA to advance patient engagement in the agency’s regulatory work 11th October 2017 • The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities. • Involving the end-user – the patient – in identifying health priorities and outcomes desired from health interventions is critically important • Today’s meeting is focused on engaging patients in the clinical trial process from design to recruitment to enrolment and retention in clinical trials, and how we communicate about clinical trial results. • Patients are increasingly collecting much of this real world data • Rapid advances in smartphones enable the creation of platforms that make it easier for patients to take ownership of their health information. It also allows us to use more of that information to advance regulatory decision-making and product science. This is especially relevant as more information is being collected in real-world settings, and more closely reflects the patient experience.
  6. 6. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Patient Centricity • What is it? A clinical study is patient-centric when, from each study participant’s perspective, it achieves his or her goals in a manner sensitive to his or her individual concerns and preferences, over the entire life cycle of the study. Journal of Clinical Research Best Practices Vol. 12, No. 4, April 2016
  7. 7. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Patient Centricity • What is it? A patient’s point of view Patient centricity means that clinical trials are designed in a way to attract, engage and retain patients through the duration of the trial. The patient should feel empowered, be an important part of the study development process, and be treated as a partner, not as a subject. From a patient perspective, it would be convenient to have study procedures done remotely or at home, but limiting all clinical contact wouldn't necessarily be a good thing since it is important to have some interaction with the investigator. My biggest frustration with lack of patient centricity is the lack of information provided by sponsors; we oftentimes don’t fully understand what we need to do in the study, and there isn’t much communication. Applied clinical trials May10 2017
  8. 8. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Improving the Patient Patient Experience • Creating a patient centric protocol Study objectives - Be clear and concise Patient input – Patient advocacy groups Patient support groups Patient reviewers Real World Experience – Focus on outcomes Real life situations
  9. 9. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Improving the Patient Patient Experience • Creating a patient centric protocol •
  10. 10. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Patient Experience and Real World Evidence • What is the patients expectation from a clinical trial? • Will this benefit me? • Will this impact on my daily life? • What should a patient be expected to go through in a clinical trial? • How many clinic visits are needed? • How many blood draws are required? • What is realistic? • Does the protocol reflect the patient’s life • Does the protocol reflect normal everyday events • How can we improve the overall experience? • Patient advocacy • Patient on the protocol design committee • “Dry runs” of the protocol • Designed with the patient in mind • Technology
  11. 11. Patient Facing Technologies PATIENT REPORTED OUTCOMES • Data reported manually by the person themselves (or their caregiver if the person is unable to enter the data) • Eg ePRO TASK-BASED MEASURES • Objective measurement of a person’s mental and/or physical ability to perform a test consisting of a defined task or set of tasks. • Task-based measures require cooperation and motivation • Eg Apps within a smartphone ACTIVE SENSOR DATA • Measurement of a person’s daily activities, • mental state, • physiological status that requires an activation step • Eg glucose monitors, peak flow meters PASSIVE SENSOR DATA • Measurement of a person’s daily activities, mental state, or physiological status that does not interrupt the person’s normal activities (i.e., it measures what the person actually does in daily life) • Eg wearable devices Mobilizing mHealth Innovation for Real-World Evidence Generation Duke Margolis Centre for Health Policy
  12. 12. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
  13. 13. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Technology • Technology should be used to make life simpler for the patient • Can the patient use the technology • What training is needed • Technology should be used to capture information remotely • Does the data needed to be downloaded or transmitted • Internet connectivity or work remotely • Technology must be fit for purpose • Does the technology facilitate what is needed • Technology must be simple • Can it be used by multiple patients in multiple locations • Make use of telemedicine • Can visits be performed remotely • Skype
  14. 14. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Patient Centric Risk based approach • Reduced risk Trials based on real life experience Focused outcomes Reduced number of data points Better and quicker reporting of data Fewer protocol deviations Better compliance Increased patient retention Simpler monitoring
  15. 15. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Improving quality Study designed around the patient Clinical outcomes Focus on clinical normality Aims of the study are simplified Patients can comply with the protocol Patient population exists There is an unmet medical need Increased probability of patient recruitment Increase patient retention Better data, quicker Less redundant data points Improved quality and improved timelines
  16. 16. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential Craig Elliott Global Head of Clinical Operations Clintec International Ltd Celliott@Clintec.com

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