Real World Data & Patient Reported Outcomes in Clinical Research

Vincent Keunen shares how two cancer diagnoses in the family motivated him to be a founder and improve healthcare.

  1. Can you tell our audience about yourself?

My name is Vincent Keunen. I am the CEO and founder of Andaman7. I have developed multiple medical IT systems, including a secure data exchange platform that is utilized by over 90% of hospitals and family doctors in Belgium, as well as a prevention EHR for managing nearly one million individuals. 

After being diagnosed with leukemia in 2007, and my 10-year-old son with bone cancer soon after, I utilized my software engineering abilities to create a tool that allows patients to handle their health information via smartphones.

That platform can now be used to improve medical research by collecting RWE (Real World Evidence), EHR data and PRO (Patient Reported Outcomes) while facilitating DCT (decentralized clinical trials), HEOR (Health economics and outcomes research) and post-market studies, quality of life surveys, telemedicine, remote patient monitoring, and continuity of care. You can read our story at http://bit.ly/a7vkblogen

  1. Can you tell our audience about Andaman7?

Andaman7 was created in 2014, and we’re located in NY (USA) and Liège (Belgium).

Andaman7 is a Belgian-American digital health company focused on improving healthcare and medical research for patients, doctors, and researchers. The company’s particular strengths are in Real World Data (RWD), Quality of Life (QoL), Patient Reported Outcomes (PRO) and HEOR studies. We enable secondary use of data coming from hospital EHRs, lab results, devices data and surveys directly from patients.  Andaman7 is the first platform enabling “patient mediated research”.

Andaman7 ‘s patient centric health intermediation platform is designed to: 

1 – help patients better manage their health data  

2 – enable outcome measurement for pharma and research  

3 – support disease management for hospitals and doctors.   

Andaman7’s unique “security by design and privacy by default” architecture does not store medical data in the cloud. Data is only stored on the edge of the network (on mobile devices) and exchanged in a distributed peer to peer method. 

As I explained above, I’ve created Andaman7 after a difficult personal journey (2 cancers in the family).

  1. What problem is Andaman7 solving & how? 

Andaman7 is solving the problem of fragmented health records and inefficient communication between patients, clinical researchers and healthcare practitioners. The traditional paper-based health records and fragmented digital records across different healthcare systems can cause delays, errors, and miscommunications, which can ultimately result in poor health outcomes for patients. Clinical research is also hampered by poor health data quality and availability.

Andaman7’s platform allows patients to store their health records on their smartphone – a guarantee of total privacy and high security.  Then the research industry can invite patients to contribute to research by answering questionnaires and sharing part of their EHR data.

  1. What have been the biggest achievements of Andaman7? 

Andaman7 has pioneered a number of important initiatives like patient mediated research, decentralized clinical trials (DCT), the unique combination of a PHR (Personal Health Record) for patients with tools for research (ePRO, eCOA…), the storage of all health data on the edge (on the smartphone, not in the cloud), as well as a number of technical innovations serving business needs in a very efficient manner (see  http://bit.ly/a7TechInno).

We are proud to serve patients first in their need to control their health data, then offer them ways to contribute to clinical research.

  1. What have been the biggest challenges for Andaman7 & how did you overcome them?

The market is extremely fragmented and most solutions have a national market (EHR vendors mainly) while clinical research is often an international project.

The lack of interoperability is one of the most frustrating problems, even though it has improved in the US in the past years (but not in other parts of the world).

  1. What are you most excited about in healthcare at present? How do you anticipate healthcare will change in the next 5 years?

Many stakeholders mention “patients first” in their communication but don’t do anything concrete for patients.  Andaman7 was created by patients (see http://bit.ly/a7vkblogen) and we aimed at offering a solution to patients before anything else: now, with Andaman7, patients can get a copy of their health data locally on their smartphone and be in full control of that data.  It is useful for them to understand their condition better, follow its evolution, ask for a second opinion, and globally be in control of their health data, hence of their health.  This is the social project of Andaman7, and everything is free for patients.

Then, in a second step, we offer to patients to contribute to clinical research and be part of studies (clinical trials, DCT, phase 4 studies, post-market and HEOR studies,…).  

Sponsors pay Andaman7 to run the studies, thanks to our advanced mobile tools for clinical research (eConsent, ePRO, eCRF, drug management, pseudonymisation…). 

What is unique is that our clinical research tools run on the same platform as the PHR of patients… this leads to more complete, rich and up-to-date information for sponsors (including what is called “real world data”).

  1. Do you have any other key messages for the audience?

It’s important to really include patients in clinical research.  Real World Evidence is becoming a necessity.  And Andaman7 is pioneering “Patient mediated research”.

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