Ryan Jones is the co-founder and CEO of Florence Healthcare, a leading testing software company.
2023 has brought major changes in the clinical research technology industry. As research sites face a backlog of clinical trials, they’re becoming more selective with which studies they take on. Additionally, these sites face capacity challenges that require technology automation to overcome. Pharmaceutical and biotech sponsors will need to win sites over by changing their outlook on their relationship with sites and providing technology that enables them.
We’re entering an era where trial sites have more power than ever in the clinical research value chain, and trial sponsors will have to pivot their relationship with technology and sites in order to get their most promising new therapies through the research process. With this in mind, here are five trends for clinical research technology vendors to consider.
As of 2022, we have noticed a sharp increase in the number of study sites that no longer have capacity for new trials. Many study sites have a backlog of 30 to 70 trials waiting to be activated.
Meanwhile, according to the U.S. Bureau of Labor Statistics, healthcare workers are resigning at a higher rate than in other fields at over 3% per month. Couple this dynamic with the fact that most clinical trial support staff run studies in addition to their core clinical jobs and you can see how research is entering a capacity crisis.
This can simply lead to more automation of generation. If generation platforms can help sites automate the collection of documents and insights, we can complete studies more temporarily and provide new remedies to patients without sacrificing compliance or safety while also allowing for more limited work to reduce tedious and capacity-draining work.
As study sites become more selective about the tests they conduct, study sponsors will work to convince top-tier sites. Sponsors will most likely focus on discovering automation-generating sites that sites already have and integrating new platforms with existing solutions.
Eighty-five percent of the United States already has an eISF platform, 95% has an eSource platform, and 63% has an eConsent platform, a software organization called activation technologies.
Sponsors will most likely respond by offering platforms that sites don’t own or aren’t happy with. They will also ensure that new platforms integrate with existing platforms. This may mean simply integrating eISF, eSource, or eConsent responses with each other or with others. systems such as electronic physical activity (EHR) recording systems.
The clinical trials industry wants help in adopting the generation. Between 30 and 40 percent of pharmaceutical and biotech sponsors say they are dissatisfied with the process of releasing sites for their generation. In turn, less than 10% of the sites that the generation provided through sponsors or study organization (CRO) contracts meet their wishes.
Clinical trial generation providers will likely achieve adoption through increased implementation processes. It’s not enough for vendors to create a site-specific build. Technology providers also want to build integrations, help users perceive their platform, and configure it according to the sites’ workflows. If vendors do this, we’ll most likely see higher site adoption rates.
At the beginning of the Covid pandemic, the industry exploded with decentralized clinical trial (DCT) communication. DCTs can mean anything from fully virtual trials in which sponsors directly access patients’ smartphones, to hybrid trials in which patients visit study sites and submit knowledge online.
But after initial optimism, all-virtual testing is losing popularity. They depend on patients’ access to generation and raise privacy and knowledge compliance considerations. They may not work for patients who need complex therapies, such as CAR T mobile or TIL treatments. As a representative of this change, DCT pioneer Science37 obtained a delisting warning letter from Nasdaq in 2022.
Hybrid testing that combines site visits and generation seems to be the way to go, which explains why sponsors are so concerned about site commissioning and adoption.
Many patients live in classical study sites or educational medical centers. The average patient travels 67 miles for test visits.
One solution is to take clinical trials to frontier sites: sites that are new to studies, such as pharmacies, network clinics, and doctors’ offices. These frontier sites can improve access, especially for economically disadvantaged or underrepresented patients. However, they don’t have generation or staff with experience in regulatory documentation or knowledge gathering. If sponsors spend too much time helping border sites get established, they may not have time to help or monitor other sites participating in the trial.
For frontier site studies to thrive, sponsors and pharmaceutical sites deserve to make an investment in infrastructure that supports this approach. This infrastructure deserves to enable the following:
• Built-in compliance tools, such as e-signature protections and audit trails, that can ensure quality compared to less experienced teams.
• Collaborative teams that give sponsors, CRO sites, and border sites the same view of the truth.
• Communication team with sponsors related to adjustments to the study.
With capabilities like these, frontier sites can manage trials more easily, and sponsors can take care of all the sites within their trial.
With research sites running out of capacity for clinical trials, it is increasingly important for sponsors to provide research sites with easy-to-use, intuitive technology that takes care of repetitive document management and data entry. If tech vendors and sponsors team up to offer this technology, sites can make better use of the time they have, and we can begin to see clinical trials accelerate in the new year and the years to follow.
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