How to test subjects at home

Tuesday morning, 8.55 hours: monthly scientific advisory board meeting at CHDR.

I was one of the first to arrive at CHDR’s auditorium this morning as I will be presenting the new study that I and Christophe, the elective student who is working with me on the project, are preparing. As the auditorium is filling up and most of the regular attendees find a seat my heartbeat slightly increases in anticipation of giving the presentation. It is not that I am not capable of giving an oral presentation, only this time we have incorporated an extra feature into the presentation that will give a live insight into the study that I will be presenting.

While Christophe is checking the functionality of our surprise feature for the last time Piet Hein van der Graaf opens the meeting by welcoming everybody. Four session are on the menu this month: three introductions on new projects and one presentation on the results of a project that was already finished. According to the agenda Christophe and I are up for the second talk so we are still relaxed. However, the presenter of the first study is experiencing some familiar problems with the national railway and will not make it in time for the first talk.

This means that we are up to kick off the meeting. While I gather my papers and find my way to the microphone I start to wonder what effect this unexpected change will have on the surprise feature.

After the general introduction to the topic of the study, at home monitoring of two patient groups using a wearable biosensor, Christophe takes the microphone to address the technical aspects of this so-called healthpatch, which is able to continuously monitor the user’s heart function, respiratory rate and body position.

Another feature present on this biosensor is stress-level detection. And this is where our presentation becomes very interesting. What nobody but Christophe and me knows is that I am wearing the biosensor on my chest and in the next slide the audience will be able to look at my live vital signs during the presentation. The thought of everybody studying my stress level already causes slight stress. As the next slide appears, revealing my live ECG, heart and respiration rate and my stress level and the audience realizes what they are actually looking at people start making jokes about my rising stress level, which is indeed the case. One person even wonders if an ambulance should be called as my heartbeat keeps on rising. Next to the feeling of exposing myself in front of the whole advisory board this nicely reflects the increased stress that many will recognize when standing in front of an audience that is eyeballing you.

An interesting phenomenon is also seen at the end of my talk, during the questions: everybody can see that my heart and respiratory rate increase when a question is asked and just before I answer these vital signs quickly decrease again, a reflection of my initial insecurity on my ability to answer the question and the subsequent relieve of knowing the answer.

Using this device to monitor patients in the comfort of their own homes will reduce burden and costs of clinical trials, as well as provide more naturalistic data as they did for us in a way hitherto impossible. Watch out for my next blog where I hope to be able to share the first results of our trials@home project!

Ellen ‘t Hart

How CHDR improves and changes the clinical trial

Naturalistic drug effect studies. Trial@Home

Traditional relationships between doctors and patients have changed. Patients are better educated than ever before, and want to take responsibility for their own lives. Although most patients value the relationship with their doctor, many now want to be informed and coached about health issues, rather than ‘treated’ by a benevolent and knowledgeable, yet somewhat paternalising physician. These changes will also affect clinical research.

Many patients with untreatable conditions are looking for alternative therapies. From the patient’s perspective, the risks associated with an unproven treatment understandably become less important if the disease is severe enough. The internet is a ready source of all types of compounds, often of dubious origin and quality. Access to experimental therapies is subject to strict regulations, and it is still difficult for a patient to be entered into a trial. Some patients now claim their right to decide for themselves, how much (unknown) risk they are willing to take with new unproven treatments. Organizations like MyTomorrows offer experimental drugs to patients who cannot be helped with regular treatments – outside of a clinical trial. Unfortunately  it is not in the patients’ benefit if new therapies are used in practice, without first being properly studied. Nonetheless, it is understandable that patients are looking for ways to accelerate the availability of new treatments – and researchers will have to respond.

Patients and healthy people are also taking responsibility for monitoring of their own health. An increasing number of genetic screens and laboratory diagnostics are offered to patients, often with medical advice. Miniature medical applications are increasingly sensitive, and large companies like Apple already offer apps and portable devices, which are able to constantly monitor physiological or behavioural indicators of healthy and performance in daily life. Unfortunately, the reliability of many of these applications is still unclear.

Over the decades, CHDR has devoted much of its time and resources to the development of tests for drug effects and disease. We use this experience in the collaboration with a number of technical parties in the joint development and validation of applications that patients can use at home, during the conduct of a clinical trial. Some examples include smartphone apps to photograph skin lesions, for new drugs in dermatology; small portable devices that continuously measure vital functions, like the Vital Connec®; and the Mini-NeuroCart®, which is based on CHDR’s drug-sensitive multimodal CNS test battery, made suitable for studies ‘in the field’. In addition, CHDR also develops tablet-based apps for ambulant patient instructions and effect measurements. And this is just part of our Trial@Home initiative, which aims to perform highly informative, data intensive studies under naturalistic conditions – during attacks of recurrent diseases, or for chronic drug effects in the comfort of the patient’s home, in their own bed at night, in the office, or any other situation that is affected by the compound – not just in the clinical research unit. The time has come that patients and researchers can team up to improve clinical research.

by Joop van Gerven