As 2018 winds down and the holidays approach, the spirit of giving has begun. Many are reflecting on the year and setting new goals for 2019 – including clinical researchers. As the industry reflects on the past twelve months, we can see rapid change and strides to overcome long-standing research hurdles. Still, despite this progress, enduring challenges remain. If the clinical research industry could receive any gift this holiday season to improve their ability to bring new products to populations in need, what might they ask for?
1. Innovation in patient recruitment
Patient recruitment and retention remain one of the biggest hurdles for sponsors, CROs, and sites. Failure to retain enough patients affects 85% of trials and results in longer timelines, financial losses, and potentially skewed statistics. These problems can result in treatments not achieving FDA approval simply because researchers did not have enough participants to arrive at a solid conclusion.
With so many apps and programs being developed to address recruitment issues, will it get easier next year? Telehealth, eSource, and mHealth aim to provide aid by decreasing patient burden while bolstering compliance. These practices are entering the mainstream in the clinical research industry, and digital health catering to out-of-hospital settings is expected to grow 30% in 2019.
Patient recruitment agencies are also continuing to pop up. These organizations focus on helping researchers design more patient-centric trials and strive to reduce dropout rates.
2. Blockchain to improve efficiency, security, and transparency
In modern clinical trials, so much depends upon fast, easy, and transparent ways to locate and share vast quantities of data with specific individuals, often across long distances. Additionally, good clinical practice requires transparency regarding where, when, and by whom data is entered.
While audit trails provide some of these insights, blockchain could take privacy, security, and transparency to a new level. In 2019, many believe blockchain will move from hype to greater to commercial deployment, and its uses will continue to expand. Regulators have started work to pave the way for blockchain, and last year the FDA defined the best way of using it to exchange health data. With these efforts, and with the potential of blockchain becoming more evident, we could be on the cusp of a new era of clinical research data storage – something that many researchers are surely looking forward to this holiday season.
3. Greater eClinical variety
A typical data management challenge is that an organization’s eClinical platform, for all of its potential benefits, often backfires, leading to study delays rather than acceleration. According to a Tufts Center for the Study of Drug Development (Tufts CSDD) study on the eClinical landscape in the clinical research industry, 77% of participants cited issues loading data into an EDC. They also stated that the average time to build and lock a study database is long, with no observed improvement over the past decade. These longer timelines amount to substantial additional costs, which can sometimes reach millions of dollars.
In a way, these struggles are no surprise. With so many eClinical platforms designed for large, complex, and resource-intensive clinical trials, researchers in other areas can struggle to find a solution tailored to their needs. For these researchers, the greatest holiday gift is a proliferation of solutions aimed at keeping eClinical processes flexible and straightforward, reducing administrative back-and-forth with programmers, and making integration easy. These benefits are especially applicable to studies in the early-phase pharma and medical device sectors, with straightforward designs and smaller patient populations – studies whose needs Medrio has worked hard for years to understand and provide for. Choosing the right eClinical tools can allow researchers to bypass common headaches, save precious resources, and get products to market faster.
So, here’s to 2019! As we look towards the horizon of a new year, we hope the clinical research industry gets what it wants and needs–and that new tools will facilitate your most productive year yet.