Partnering with Patients for Clinical Trials 2016 A HealthXL Report on improving patient engagment in clinical trials

The Leading Global Platform for Digital Health Collaboration

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Table of Contents

Editorial

The Challenge

Catalysing the Community: Clinical Advisors

Marketplace Review

Suggested Experiment

Your Personalised View of the Digital Health Market

Appendix 1 - Market Breakout

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Editorial: Patients as Partners in Clinical Trials

Only 2-5% of adult US cancer population is enrolled in Clinical Trials

The pharmaceutical research enterprise is under tremendous pressure to innovate in order

to discover new drugs and commercialize their portfolio more effectively. The average cost

to develop a drug is $2.6 Billion and takes 10 yearsi. This model is unsustainable. To make

matters worse, upon launch, enterprises learn that patients may not value the intervention

as expected. 

Traditionally, clinical trials have suffered from a number of challenges including enrolling

patients, identifying trial sites, reducing study drop-off rates, to name a few. 80% of industry

clinical trials do not meet patient recruitment timelines and the current drop-off rate across

all trials is 30%. There is also increasing pressure on clinical trial providers to become

“patient centric”, to leverage technology, and to push the envelope on how health is

measured. 

What’s the solution? How does one create a more effective research enterprise? The answer

is more straightforward than we might think – partner with patients. Lets make patients

consider clinical trials a care option.

A number of key trends make this easier. First of all, patients are more self empowered than

ever before and are seeking to get involved. Solutions can further streamline the process by

meeting patients where they are – making the clinical trials easy, convenient, and

accessible . Virtual clinical trials, remote data capture via wearables, and research through

care delivery are just a few things that can delight patients while improving the overall

research process.   

For example, in the area of oncology, a number of care solutions aimed at providers capture

tumor type underlying genetics, and treatment effectiveness – which can act as parameters

to assess trial eligibility. Further, a number of patient communities and real-world evidence

solutions enable researchers to access patients and learn about patient’s needs more

directly, and even enable patients to co-design studies.

With all the changes happening within clinical trials, we invite you to read this report that

highlights a number of solutions and approaches to next-generation clinical trials.

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HealthXL Challenge

Improve patient engagement in clinical trials by creating a landscape in which it is

simple for a patient to find and participate in a clinical trial. Patients consider clinical

trials as a care option and have the power to find out themselves which clinical trial

they are eligible for.

Vision

Taking cancer patients as a model group, the challenge is to meet the planned

enrollment of patients in 90% of trials and to reduce patient ‘drop-off by 20% in trials

via the implementation of digital methods to improve the patient experience in

clinical trials.

Challenge

•  Involve the patient at the earliest possible planning stages to ensure the trial

design and protocol will match a patient’s lifestyle and needs.

•  Empower the patient to be able to identify the trails that he/she are eligible for

without the need to always go through clinical providers and clinicians.

•  Explore other technologies that offer the patients the opportunity to connect and

engage more meaningfully with both clinical trial organisers and other patients.

Defining the challenge

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Industry Advisors

HealthXL has a large and growing community of advisors made up of clinicians, healthcare industry professionals, venture capitalists, payors, serial entrepreneurs, and innovators.

The top experts in patient engagment in Clinical Trials within the HealthXL community are:

Catalysing the Community

Martin Kohn Chief Medical Scientist

Sentrian

Martin Naley Founder

Cure Forward

Colm Galligan Medical Director

MSD

 Dr Galligan has extensive experience in setting up multinational phase 2,3 & 4 clinical trials as well as supporting the development of Investigator Sponsored studies

Dr. Kohn is an alumnus of MIT, Harvard Medical School and NYU and is a fellow of both the American College of Emergency Physicians and the American College of Physician Executives.

Martin is the founder of Cure Forward, who help people get tested, get their data, and then put their data to use to understand their disease and find options for treatment, including clinical trials.

Brendan Buckley Chief Medical Officer

Icon

Jamie Goldfarb Patient Advocate

Cindy Geoghegan Patient Advocate

Brendan has extensive experience in clinical trials and chairs several independent Data and Safety Monitoring Boards for medium to large cardio-metabolic and rare disease clinical studies

Cindy and Jamie are both cancer survivors, Cindy a breast cancer survivor and Jamie melanoma. They both now represent the patient community as advocates, and each participated in clinical trials that led to the treatment of their cancer.

Industry Advisors

Catalysing the Community

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HealthXL reviewed the digital technology marketplace, focusing on companies that could potentially address the Challenge set.

Solutions that addressed the challenge set were found to have one of more of he following capabilities: patient finder for clinical trial (CT) organiser, CT finder for patient, CT finder for physician, virtual clinical trial, tool to personalise clinical trial for patients, education, real world data leverage, electronic informed consent software, ride share company to get patient to CT.

Solutions that put the patient at the centre of the clinical trial were selected as the most effective at engaging patients in clinical trials. HealthXL chose the top 3 capabilities addressing patient engagement in clinical trials. They were 1) CT finder for patient, 2) virtual clinical trial, 3) tool to personalize clinical trial for patient,.

Marketplace Review

CT finder for patient

Virtual clinical trial

Tool to personalize clinical trial for patient

Online database of ongoing clinical trials informing patients what CTs specific to their disease are available.

Clinical trial that is conducted online - from patient enrollment to measuring biometrics, to monitoring progress.

Aids patient in finding clinical trial suited exactly to their disease type and needs.

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Companies Designing Clinical Trials for Patients

Name

Science 37

Mytrus

ePatient Finder

Patients Like Me

Thread Research

Circulation

VitalTrax

TrialX

Transparency Life Sciences

See Appendix 1 for description of companies listed.

Software to streamline patient recruitment

Database for patients to source clinical trials

Metasite mobile based CT paltform

Remote patient reserch platform

Database for patients to source clinical trials

Leverages real world oncology data to improve CT design

Electronic informed consent software

Ride share to get patient to trial site.

Connects physicians to CTs for their patient

Crowd Sourced Clinical Trials platform

Writes and organise CT info in a easily understandable way

Patients educate each other on CTs available

Strata Oncology

Match late stage cancer patients to clinical trials

Patient Finder for Clinical Trial Organiser

Clinical Trial Finder for patient

Clinical Trial Finder for Physician

Virtual Clinical Trial

Tool to Personalise Clnical Trial for patients

Education Misc.

Flat Iron

Custodix Custodix is the driving force behind real world data collection

Patient Finder for Clinical Trial Organiser

Clinical Trial Finder for patient

Clinical Trial Finder for Physician

Virtual Clinical Trial

Tool to Personalise Clnical Trial for patients

Education Misc.

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Companies Designing Clinical Trials for Patients See Appendix 1 for description of companies listed.

Crowdsourced database of all clinical trials

Assists in finding personalised CTs for patients via Trial Exchange forum.

Cure Forward

Kayentis

Open Trials

Antidote

FindmeCure

One Voice

Neoclinical

Clinithink

Double Blinded

Trinetix

Molecular Match

Connects patients with clinical trials

Provides genomic sequencing test for patient

Educates patients on the science behind their cancer

Helps patients understand treatments that are available

Patient community for Orphan Disease patients

Database for patients to source clinical trials

Registered nurses help patients to find clinical trials

Provides lists of patients based on trial protocol eligibility

Motivational messages, alerts, reminders, integrated into eCOA solution

Crowd Sourced Clinical Trials platform

Helps cancer patients find CTs

Helps cancer patients find CTs

Name

Through screening and referrals, finds patients for CROs

Researchers can see patients with specific genetic data on Trial Echange Forum.

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Capability CT finder for patient – informs patient on ongoing CTs

Antidote connects patients with clinical trials by organizing the world’s research information and presenting it to patients.

How do they engage the patient?

Partners

Based

Founded

Science 37 is a mobile based clinical trials company that removes geographical barriers for patients allowing them to bring research into their homes.

Cure Forward provides patients with a genomic sequencing test which they can use to find their best suited clinical trial via clinical trial exchange.

Antidote Match uses NLP and AI to help people find their best clinical trial match. Antidote Connect Network is an online network of health portals, patient organizations and advocacy groups aiming to connect patients to clinical trials.

Mobile app Nora is a technology platform that integrates telemedicine technology into the clinical research process enabling patients to engage in remote clinical trials.

JDRF, Healthline, CentreWatch, GALAXY

Science 37 has 29 partners such as Genentech, Novartis, Naked Biome, Harvard Clinical Medical

Cureforward has 12 partners including Novartis and Quintiles, 3 non-profit organisations such as, Fight Colorectal Cancer and Diagnostic Test Providers such as Cynvenio.

UK and US California Boston

2010 2014 2014

Virtual Clinical Trial Tool to personalize clinical trial for patient

Cure Forward’s process is 3 steps: 1.Patient receives genomic sequencing 2.Patient receives test results 3.Patient can post themselves of clinical trials exchange to find best suited trial.

Company

Deep Dive

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Suggested Experiment

Using a digital health solution improves patient engagement in clinical trials. Patient

recruitment for clinical trials will increase and patient drop off during clinical trials will

decrease.

Working with a Contract Research Organisation the hypothesis would be tested in a

two-armed randomized control oncology trial. Recruitment of oncology patients will

be conducted.

•  Control Group – Cancer patients that are recruited without using a digital

intervention, and are not given a digital intervention during the trial.

•  Study Group – Cancer patients that are recruited using a digital intervention and

are given a digital intervention during the trial.

•  Study length – 6 months, day 1 is the first day patient recruitment for clinical trial.

Show interest

Interested in this challenge?

Hypothesis

Methods

Primary Endpoints:

Taking cancer as a disease category of interest, HealthXL proposes the following

experiment:

•  Number of study group patients vs control group patients that enrolled for clinical trial

•  Number of of study group patients vs control group patients that stayed in clinical trial

for study length.

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Bloomberg meets LinkedIn for digital health

The HealthXL Platform brings together key market stakeholders in digital health, and empowers them to collaborate and learn from each other

•  Gain global coverage of market intelligence for innovative high growth companies

•  Access shared strategic learnings from market thought leaders

•  Close the loop for new collaborative projects, bringing together customers, solutions, funders and precise expertise

HealthXL Members:

Request to join the HealthXL Platform today at manage.healthxl.co

Join today

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With thanks to our member Icon for proposing this challenge

Authors Ruth Coleman Lead Market Analyst, HealthXL

ruth@healthxl.org

Julie Carty Head of Member Engagement, HealthXL

julie@healthxl.org

References

i. 2016, Tufts Centrer for the Study of Drug Development

ii. Fouad et al., 2013. Enrollemnt of patients with lung and colorectal cancers onto clinical trials. Journal Of Oncology

Michael Garrow Business Analyst, HealthXL

michael@healthxl.org

Carlos Rodarte HealthXL Advisor

rodarte.carlos@gmail.com

“ The importance of patient engagement in clinical trials shouldn’t be underestimated. Where patients have been engaged in clinical trial design in particular it has proven to substantially improve patient recruitment, retention and overall compliance rates. Wearables continue to grow in their importance in clinical trials capturing more data more accurately while acting as a real-time source of information to patients”.

Tom O’ Leary, Chief Information Officer at Icon

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Flat Iron is a cloud based software that support the continuum of cancer care. It organizes the world’s oncology information.

Vitaltrax in a cloud based software solution that gives patients guidance with access to clinical trial information and also has eCOA and EDC features.

Double Blinded is a crowdsourced clinical trials platform. Their primary focus is to provide users with a reliable way to determine the effective ness of a given lifestyle decision.

Transparency life sciences is an online network that aim to design clinical trials via crowdsourcing methods and provide open access to clinical trial data without limitations.

Trinetx is a federated data network that connects clinical researchers in real time to the patient populations they are attempting to study.

Science 37 is a mobile based clinical trials company that allows patients to bring research into their homes.

FindMeCure is the “google for clinical trials” - users can search, weigh, and understand treatments in development

Companies 1/3

Appendix 1

PatientsLikeMe is an online network of over 400,000+ patients who can share their knowledge on treatment options, ongoing research, and support each other.

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Appendix 1

Molecular match helps cancer patients find all trials available for their specific type of cancer.

Strata oncology's goal is to expand late stage cancer patients access to tumor sequencing and precision medicine trials.

TrialX is building an ecosystem of solutions to build a robust online presence for clinical trials.

ePatientfinder connects physician’s and EHR data to clinical trials

Antidote connects patients with clinical trials by organizing the world’s research information and presenting it to patients.

Thread Research is a Turn Key Remote Patient Research and Care Software that enables remote patient research via Apple Researchkit and Carekit.

Companies 2/3

Neoclinical is a group of registered nurses that match patients with clinical trials.

Kayentis design eCOA solutions that are designed to improve clinical trial compliance with solutions that are intuitive, efficient and user friendly for patients.

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Appendix 1

Cure Forward provides patients with a genomic sequencing test which they can use to find their best suited clinical trial via clinical trial exchange.

Clinithink is CLiX ENRICH for Clinical trails interrogates rich patient data from within EMRs, PROs and and EDC systems to optimize patient recruitment processes.

Circulation is a non-emergency medical transportation service that through its partnership with Uber can assist in physically getting patients to trial sites.

Companies 3/3

OneVoice is a platform for encouragement, knowledge and collaboration in rare diseases. Their platform rareClnical provides information on ongoing rare disease clinical trials.

Mytrus has developed enroll – a mobile informed consensus and patient enrollment platform for clinical trials.

Custodix is a soltuion that collects and shares privacy senstive data. It is the driving force behind the InSite Platform which aims to accelate clinical research by leveraging Real World Data.