It’s no secret that patient recruitment and retention remain among the most significant hurdles in clinical trials. As research becomes more globalized and sophisticated, many sources now rank patient issues among the top three barriers to completing trials on time and within budget. A few recent stats show the importance of patient centricity in clinical trials:
• 85% of clinical trials fail to retain enough patients.
• 80% of trials don’t finish on the expected timeline – 20% are delayed half a year or more.
• The average patient dropout rate is around 30%.
These numbers can seem alarming, especially since patient recruitment can account for as much as 40% of total research costs. Solutions to these challenges are by no means simple; however, emerging technology and strategies could break down barriers to create a more efficient process. Still, many are reluctant to try them. Why?
Obstacles to change
While patient centricity is a buzzword that can generate excitement, it also brings up several key concerns. Here are two of the most common:
• Regulatory matters: Many worry that authorities will not accept a new way of doing things, which could result in huge setbacks.
• Return on investment (ROI): It’s difficult to estimate returns on a novel approach or technology.
Experts debate if pharma can have be both patient-centric and growth-friendly – but we’re optimistic that they can. While the transition may cause organizational growing pains, new protocols and technology that focus on patient value carry the potential to set in motion a virtuous cycle that could reduce participant burden, make researchers’ jobs easier, and deliver a higher ROI to investors. Patient centricity initiatives could also help to optimize clinical trial workflows and reduce costs, just like the technology Medrio is dedicated to developing.
We see now as the time to reorganize processes to enhance efficiency and harness the value of patient centricity. Organizations that take these steps early position themselves to accelerate R&D, help more people in need, and secure a leg up over the competition. Let’s look at a few strategies and technologies gaining traction:
Better patient centricity through stronger relationships
Matching patients to trials is a perennial challenge. A 2011 report from the Tufts Center for the Study of Drug Development found that two-thirds of trial sites don’t meet enrollment requirements. This could be due to potential participants being overwhelmed by too many options, inconvenience due to time and distance, or simply that many people only look to clinical trials as a last resort.
With benefits to researchers and patients alike, several patient recruitment and clinical trial matching startups have emerged. Some of these programs and organizations use AI and clinical data to match patients to trials, while others advertise to millions of potential patients each month and only ask researchers to pay if they recruit successfully.
Direct data capture and other forms of eSource also hold many benefits for researchers and participants. Real world data (RWD) already helps match patients to trials, and many are optimistic that its applications will expand in the future. Also, in October 2018, the EMA recognized key benefits of DDC and highlighted its value for efficiency and data quality. Not only does this platform hold the potential to reduce patient burden by decreasing the need for patients to visit sites, but also it drastically reduces monitoring and allows researchers to work more effectively.
Keeping patients engaged and informed
When participants are clearer about a study and its risks, they’re less likely to drop out. Having empathetic site staff that listen to patients and take time to answer their questions can go a long way to increasing patient comprehension. Additionally, electronic informed consent (eICF), such as our eConsent platform, allows researchers to use mixed media to further ensure that patients fully understand what they’re considering.
There are other techniques to keep trial participants engaged throughout the research process. Non-adherence often rises to approximately 40%, impacting timelines and costs. Text messages and moderated trial communities via social media are relatively simple methods that have proven effective in keeping patients connected and following protocols.
The patient is not the only one who benefits from this focus. While we strive to help populations in need, it’s important to keep in mind that weaving the patient voice more deeply into the clinical trial process also helps researchers to develop higher quality products with smoother workflows at lower costs. This, after all, is what we here at Medrio are all about. By taking advantage of new methods and technology, we expand the potential for all of us to get greater value from the future of clinical research.