#Patients2019

Taking the Study to the Patient –A True Patient-Centric Service

Presented by:Gail AdinamisFounder, CEO

GlobalCare Clinical Trials, LLCEO

GlobalCare Clinical Trials, LLCClinical Trials, LLC

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Patient-CentricityWhat does patient-centricity mean?

Making the study subject a central consideration in the design and implementation of a clinical trial; allowing the subject to participate in a study and carry on with the least disruption to their normal daily routine

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CTTI Initiative – Mobile Clinical TrialsTo facilitate the adoption and appropriate use of mobile technology in clinical trials, CTTI initiated the Mobile Clinical Trials (MCT) Program focusing on the following key areas to identify and address the challenges of planning for and conducting FDA-regulated clinical trials using mobile technologies:• Decentralized Clinical Trials (DCT)• Novel Endpoints• Stakeholder Perceptions• Mobile Technology

https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials

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Patient-Centric ServicesBy conducting selected protocol visits at home, workplace or other alternate location, mobile healthcare professionals offer a way for patients to participate in trials regardless of:

• Study duration• Frequency of visits• Disease state • Distance to site• Vacation/travel• Family, school, work or community obligations

Making trials more convenience and comfortable for patients will result in more patients willing and able to participate and remain in the study

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Global Service Model Organization

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Global Service Model Logistics

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Mobile Health Care Services (Virtual or Traditional Studies)

• Blood draws for local and central laboratory processing(including safety labs, pK, specialty labs) and other biological sample collections

• Study drug administration (infusions, injections, topical)• Device management (infusion pumps, mobile devices)

• Clinical assessments (vital signs, ECG, etc.)• Compliance checks and administration of questionnaires• Patient training/education (e.g., self administration, device management)

• Local and central pharmacy services• Available for all age groups

• Available for all phases of development and various therapeutic categories

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Case Scenario #1

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Case Scenario #2

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Case Scenario #3CASE STUDY:• Phase III study•Multi-center, North America and Europe• Rare disease (Alpha-1 antitrypsin deficiency)• Randomized, double-blind, cross-over study (16 wk double blind, 8 wk open label)• IP administration, weekly 1-hr IV infusions (+/-1day); serial pK samples and safety labs• Limited patient population

RESULTS:Ambulant care services provide rapid enrollment and high compliance:• Study start delayed by 11 months, but completed enrollment ahead of schedule – all

patients (n=59) enrolled within 3 months• Services available weekends and evenings• Services available for emergent/out of scope needs (retests, traveling patients)

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Case Scenario #3

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Testimonials“It would be very difficult to conduct serial blood draws by regular site staff and the assistance of home nurses has been very valuable” (Study Site)“Subject would have to drop-out of the study, when he disease progressed and he was no longer able to self-inject the drug. He is located 500 Km away from the site.” (Study Site)“We have a subject living in Northern Ireland and our site is located in London. Home visits are key to keep the subject in the study. Most of our patients choosed to be visited at their homes, even when located not so far” (Study Site)"In my opinion, home care services are of major importance in the context of clinical trials, since they contribute to minimize study travels burden, reinforce protocol compliance and most of all, to an effective increase in patients quality of life.” (study site)“Subject did not want to stay a whole day at the hospital. Instead, she was sunbathing at her garden” (home nurse)"With my restrictions, my husband would have to miss days off work to take me to my hospital appointments. It would be all so much more difficult." (patient)"With your availability and your work, I'm hopeful that I can have a better quality of life." (patient)

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Testimonials (cont.)“The patients were delighted that we went to their homes because some of them live more than 100 km away from the site. Some of them told me that if GlobalCare did not exist, they would have left the study because was impossible for them to go to the hospital once a month. These patients, due to their illness cannot drive, walk alone or even take a train. We had a serious problem during the Study: the PI died. At that time, some patients thought of leaving the study, but between the site and me, we convinced the patients to continue. Today, I still have contact with my 5 patients and even they ask me when they have a problem not related to the study because, in the end, after 4 years, I will be their personal nurse the rest of my life.” (Service Provider)

“I want to share with you the story of a young subject that I have personally taken care of since 2014. During the study he decided to have a child and to marry his girlfriend. I interpreted it as a symbol of hope and vision of the future. I myself sang several times baby rhymes with his child during the study visit. This vision of the future can be only if a patient has the belief to manage their own disease. Disease management is also to believe that treatment can be effective. Study drug development for chronic severe disease is not only an investment or a project but also a hope for a future. ” (Country Coordinator/Service Provider)

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Win-win Benefits• Patients/Family appreciate the convenience, flexibility and comfort of

ambulant care services at home, workplace, etc.• Investigators - able to recruit and retain patients from a broader

geographic area, better compliance; ensure geographic and ethnic diversity

• Sponsor - realization of shorter development timelines• Consumers - get access to new therapies faster

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Key Take-Aways• Whether you are conducting traditional, hybrid or

virtual trials, incorporating home care visits can be beneficial

• Seek out vendors with proven experience to help guide you through the logistics

• It should always be about the patient

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Local Touch, Global Reach

Q&AThank you for your attention!

Gail AdinamisGlobalCare Clinical Trials, LLC

+1 847 282 3270gadinamis@globalcarect.com

www.globalcarect.com