Patient centricity is the aspiration for the healthcare industry. Putting patients in control of their own health journey and empowering them to make educated decisions will certainly form the future direction of medicine.
In drug development, patient participation is crucial to the success of clinical trials. The industry recognises the demand for better in-trial patient data and improved communication between clinicians and patients. When the patient is at the centre of the trial, researchers see improved uptake and retention, leading to more dependable results.
Following several years of research and development, SQN makes patient centricity a reality with the launch of the electronic Patient Reported Outcomes (ePRO) and Clinical Outcome Assessment (eCOA) app: SQN Health ePRO.
“Historically, clinical trials have been designed with the goals of the pharmaceutical company in mind: to develop and deliver drugs to market in a safe, fast and cost-effective way,” explains Tony Rees, Director at SQN. “Of course, these goals are important and will continue to be key elements in trial design and deployment, but there is a growing focus on the need to put the patient at the heart of the trial. In fact, in order for trial numbers to increase, and withdrawal rates to fall, the patient must be at the centre of it all, from planning and analysis, throughout the trial duration and in the reporting.”
Breaking the barriers to patient engagement
One of the key barriers to true patient involvement has been the data collection methods used in between visits to the research centre. Patients are still being asked to complete paper diaries or use bespoke electronic devices to record their data. These methods are intrusive and often clumsy to complete, leading to noncompliance with the protocol and, because of poor engagement, early withdrawal from the trial. Although they are engaged at the beginning of the trial, patients can start to feel undervalued, believing that the trial is one-sided and focussed only on the data. This can all contribute to a feeling of isolation.
“These methods also introduce a margin of error that is hard to discount. Data is often re-entered from handwritten accounts, often a long time after it was originally documented, leading to missing or inconsistent records.”
Putting power in the hands of the patient
“We’ve spent the last few years engaging with patients, carers, pharmaceutical customers and regulatory professionals to develop an enhanced way to collect in-trial data from patients in a way that is unobtrusive, engaging, inclusive and reliable. We’re excited to say that we have achieved this, and much more, in the launch of our patient-centric solution: SQN Health ePRO.”
“SQN Health ePRO is an app-based solution accessible through iOS or Android smartphones and tablets, as well as computers and laptops,” Rees continues. “Any patient involved in a trial can download the app and immediately access their trial profile. Anytime, anywhere, patients can input their trial data, fill out their online diaries, upload images and videos, message their physicians and report any symptoms or effects that they deem important. The app includes a symptom tracker, which provides a more holistic view of the progress of the trial. By measuring cognitive and physical signs, we gain a more comprehensive view of the patient’s response to treatment.”
Bespoke trials built around the patient’s needs
The ePRO is fully customisable for each and every trial, providing pharmaceutical and biotechnology companies with a bespoke, accurate and engaging way of collecting trial data. Patients are immediately more connected to their trial and this leads to enhanced protocol compliance and continued trial participation.
“In essence, the app is built around the patients, anticipating their needs, adapting to the answers they give and providing access to the support they require,” explains Rees. “Of course, the app will be fully integrated with our secure electronic data capture (EDC) system, allowing for real-time data analysis and trial management. eDiaries, consent forms and questionnaires are all available on one platform, providing advanced real-time data analytics, with granular detail on every aspect of the trial.”
Changing the face of patient data
The ePRO is a key addition to SQN’s Technology Ecosystem, SQN Health, which brings together an entire trial or development program in one cloud-based portal. This ecosystem connects patients, investigator sites, laboratories and all project and clinical professionals involved in patient care and trial management.
Clinical oversight and patient engagement will be greatly enhanced. Clinicians will have real-time access to patients’ clinical trial data allowing remote monitoring and intervention when necessary. Advanced, real-time data analytics, incorporating state-of-the-art artificial intelligence (AI) reporting, is a game changer in the management of patients and their data.
“SQN Health will change the way that we look at trial data. Patients will be able to influence and contribute for the better, allowing for in-trial adjustments and qualitative free-form feedback. With better patient engagement, we’ll see better patient retention rates, more accurate data and safer, more cost-effective trials. This, in turn, will help to bring drugs to market quicker and at lower costs compared with other options.”
“We shared the app with several of our clients before launch. One Biotechnology company CEO said, ‘this is going to change the landscape of clinical research and patient involvement.’ Our response: that’s certainly the ambition.”
For more information: www.synequanon.com/services/sqn-health/