The cost of drug development totalled approximately one billion U.S. dollars in the decade from 1990 to 1999, but has more than doubled in the past years, reaching around $2.6B today, thanks in part to challenges in early stages of clinical trials that impact R&D costs. This drastic increase has sponsors looking for new financial and operational solutions in clinical trials. For many, this could mean adopting new technology and forcing their participating sites to use it. However, technology is only useful when implemented in the correct way, and when taking site challenges into consideration.
Sponsors demand faster study startup timelines, more visibility into the trial status, and increased efficiencies with internal and external collaboration. When a sponsor thrusts a technology onto the site, it doesn’t always function well with the site’s existing workflows and adds to a growing laundry list of systems and application they must learn to navigate.
On average, site staff are already using eight to ten different systems to manage their clinical trials1. You run into a few issues when leveraging that many systems, including the risk of duplicative workflows, inconsistent communication channels, and increased inefficiencies. And the vicious cycle of inefficiencies is carried out of the paper world and into the digital world, while delays in study timelines and the expenses continue to mount.
Technology is the solution, but not in the way it is currently being pushed. Sponsors and sites must work together to support and empower technology transformation with the site at the center. By empowering the site with technology that works for its structure and workflows, both the sponsor and site will see improvements in operational efficiencies.
In addition to increased efficiency, there are several other arguments supporting why sites should be at the center of any clinical trial technology decision.
- Collaboration is easier
When sponsors evaluate technology, they may focus solely on features that allow collaboration between the sponsor users and the site users. When this happens, sponsors largely overlook how well the technology supports the site’s existing workflows.
The problem compounds when sites work with multiple sponsors that each have a different platform. Site staff waste time jumping from platform to platform and are burdened with having to learn how to operate each system. This gets cumbersome quickly, especially if sites must upload the same documents and maintain versions in various systems.
Every site has different needs, and they collaborate with sponsors more effectively when they maintain workflows that compliment those needs. Sites should be at the center of any technology decision that requires them to utilize the system, allowing the opportunity to provide knowledge sponsors don’t have access to, like internal processes.
Approaching technology decisions as a partnership allows both sponsors and sites to gain the efficiencies they seek and successfully reduce trial bottlenecks.
- Integrations are seamless
When sponsors push new technologies without consulting the site, it breaks automated workflows and efficiencies. Sites must resort to manual processes that cause delays, incorrect and incomplete data reporting, and additional monitoring. Sites are typically proficient at using their existing technology and so are sponsors. Issues arise when those technologies are unable to communicate with one another.
When sponsors and sites collaborate on technology decisions, they can choose integration-friendly systems that help streamline processes and make the clinical trial data available across existing and future systems without manual effort. Integrations also provide better reporting and visibility into the clinical trial data and status. It is imperative to let the sites be the decision makers on what works the best for them.
- Communication is fluid
The sponsor, site and CROs typically all come with their pre-existing technology stack and communication channels, but sites are the main source of data and information during a clinical trial, which means they are the center of the communication flow. When communication is jumbled with multiple systems, partners, and demands, operations slow and costly delays can ensue.
Putting the site in charge of deciding the communication channels takes away the stress of learning a new way of communicating and prevents any hiccups in information sharing. Sponsors should let the sites use their routine communication methods and reduce their operational burden since it is familiar and repeatable for the site users.
- Participant management is a priority
Participants are the driving force behind any clinical trial. All participant activities filter through the sites, who are responsible for recruiting participants, delivering care, collecting data, and completing regulatory documentation for FDA approval. All of that data, information, and documentation is then sent back to the sponsor, sometimes filtering through a CRO along the way.
Participants also interact with some site technologies, for instance eConsent platforms. For that reason, it is imperative that sponsors hear and address sites’ concerns and challenges regarding technology decisions to ensure participants stay safe and quality data is collected.
- Regulations are upheld
Studies themselves are becoming more complex. Trial timelines are increasing, and participating sites span different geographical regions that have varying rules and regulations. Most sponsors or CROs have to coordinate with multiple sites for a single study. The sites know best what regulations apply to them and what to look for to verify that the technology adheres to them. Allowing sites to select the appropriate technology that adheres to their specific regulations helps keep the safety and integrity of the clinical trials data.
In Conclusion
Survey results from Centerwatch, a leading provider of clinical trial news and information, found that less than 10% of investigative sites believed that the clinical trial technology solutions provided by sponsors and CROs were meeting their operating needs. As COVID-19 has changed the clinical research technology landscape, sponsors, CROs and sites have rushed to find solutions that allowed for remote access and monitoring.
Many technology vendors that serve the clinical trial community focus on the sponsor, not the site. This focus can cause increased operational inefficiencies and costly delays by making it harder for sites to complete work in a streamline fashion. By placing sites at the center of technology decisions in clinical trials, sponsors can reduce the burden from the sites of maintaining yet another system and keep them focused on what matters the most – the patients and the study quality and completeness. This is a triple win-win-win for the sites, the sponsors, and the participants.
About the author
Kajal Jain is the Director of Product Management at Florence Healthcare. She brings more than 20 years of experience in the software industry to the organization, both in Software Engineering and Product Management. At Florence, she manages product strategy, product operations, and quality assurance.