Clinical trials in the biotech and pharmaceutical industries are notoriously slow-moving and expensive. A recent study1 estimates the median research and development investment for new drug approval at over $985 million; the entire process can take over ten years2.
Ten years is an eternity for patients waiting for life-changing therapies. Researchers must find ways to accelerate pharma and biotech research safely.
Recruitment & Retention: Over 25 percent of clinical trials fail to enroll enough patients; 85 percent fail to retain them. When protocols aren't sufficiently 'patient-centric,' recruitment slows, and compliance and engagement rates suffer.
Data Collection: Conventional trials typically conduct 'on-site' vitals monitoring, placing the lion's share of the burden on participants to do the travelling. This punctual approach to monitoring also makes it challenging to measure outcomes consistently and is further exacerbated by last-minute completion of diaries by procrastinating participants (parking lot syndrome). Such limitations result in data gaps that existed pre-COVID-19 and have been amplified since.
Risk Management: Traditional RCTs are not designed to monitor vitals in real-time. This time-lag makes it challenging to identify AE/SAEs and may miss them altogether.
Data Entry/Transfer Error: On-site monitoring typically dictates that data is captured and recorded when a patient is face-to-face with an HCP. This creates the potential for recall bias or typos produced during data transfer (i.e., from a digital document to a centralized database).
Our trials are designed to overcome these paint-points. Keep reading to learn how.
Evaluating the Safety/Efficacy of an Oral Investigational Drug from Home
To date, COVID-19 trials have been primarily managed in hospitals. However, most symptomatic patients are recovering at home.
ObvioHealth recently-launched a randomized, double-blind placebo-controlled decentralized study to test the safety/efficacy of a COVID-19 treatment using a combination of mobile app, devices, and assessments by in-home nurses.
Participants are trained to use a kit with five digital devices for remote monitoring of vitals including: temperature, respiratory rate, heart/pulse rates, blood pressure oxygen saturation, body weight, and cardiac rhythm and QT interval (ECG). In parallel, they record their symptoms via a daily digital diary on the app.
Proving the efficacy of a new treatment for menopausal symptoms
A leading global package goods company sought to study the efficacy of an herbal blend on menopause symptoms and quality of life.
The ObvioHealth app and decentralized platform, was used for remote vitals monitoring and data collection. Given the subjective nature of symptoms such as hot flashes or anxiety, ObvioHealth employed an electronic patient diary and digital questionnaires, via the app, to relay health-related outcomes.
In this way, researchers minimized data gaps by allowing the flow of qualitative data directly from the participant to the research staff.
The ObvioHealth App
Our proprietary application brings clinical research into people’s homes, making it easier for them to participate, and easier for researchers to collect robust data that reflect real behaviors.
Recruitment & Onboarding
Recruitment is often a huge barrier to trial success. ObvioHealth uses digital targeting methods to find untapped populations. We identify the online behaviors that point to people with a positive pre-disposition for a specific trial and, because our studies are virtual, we are not geographically tied to a site location.
Once recruited, we enroll participants through virtual prescreening/screening and e-consent. This eliminates the burdensome cost of site retention and staffing requirements, and often shortens the recruitment period.
The ObvioHealth platform and app incorporate multiple data capture technologies to adapt to the needs of any given trial. These include simple survey-type completion of questionnaires and diaries, image, video and audio capture and use of wearables. Complementary data collection methods ensure more robust data real world outcomes.
Our platform makes it easy to trigger, track and manage products and payment of incentives. ObvioHealth can reimburse participants with the stipend program that is fully virtual. We ship any needed study supplies or devices directly to the participant’s home.
Medication Adherence & Adverse Events
An important advantage of ObvioHealth’s app is the real time remote monitoring of medication adherence and potential adverse events. Our escalating system of reminders and immediate AE/SAE detection make our studies safer, while also improving medication adherence.
Higher compliance, higher retention, more accurate data
Our easy-to-use, convenient app makes it easier for people to remain compliant. There is little to no time wasted travelling to clinical sites, so there are fewer dropouts. All of this means that studies end on time or ahead of schedule. And because participants are able to report more real world and real time experiences, the resulting data is more accurate and reliable.
1. Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. JAMA. 2020;323(9):844–853.doi:10.1001/jama.2020.1166
2. Research, P. Biopharmaceutical R&D: The Process Behind New Medicines. 2015.