Information is power. The individual who holds the right information has the advantage over the one who doesn’t. However, what if that first individual has the wrong information? Or possibly, not enough information? If both parties withhold their information from one another, how will they ever know what it is they are missing?
In the clinical research industry, this challenge is all too familiar. Industry stakeholders have consistently struggled to effectively communicate necessary information to enable efficient and successful clinical trials. For many years, research organizations have worked in silos, collecting, managing and storing clinical information independently from one another. Not only does this isolated approach limit the value for each stakeholder during the clinical trial process, but it also negatively impacts industry relationships.
It’s no secret that the relationship between clinical research sites and coordinating centers (sponsors/CROs) has historically been strained. Continual miscommunication between the two parties leads to unanswered questions, misunderstanding and a lack of trust on both sides. This lack of trust leads to problems with severe consequences, including increased drug costs, increased time to market and poor experiences for study participants and personnel.
Lack of effective communication and inefficiencies in clinical trial conduct are deeply rooted in a misalignment of motivations between clinical research sites and sponsors.
Misalignment of motivations
A stark disconnect between sites and sponsors has created barriers that influence the research industry, clinical trial participants and public as a whole.
Many times, sponsors are motivated to conduct clinical trials in a way that gets drugs to market as quickly and cost effectively as possible. Sites are often motivated to conduct clinical trials in the most efficient, patient-centric way possible and still hope to make a profit. Over the years, issues have perpetuated because sites and sponsors focused solely on their own needs, wants and limitations without regard for the needs, wants and limitations of the other. Each party asks for too much—or the wrong things—from the other, further propagating the imbalance between workload and costs associated with conducting clinical research. This disconnect causes research operations to suffer and lack of necessary information becomes a stifling challenge.
Site selection and feasibility
During the study start up process, both sites and sponsors are playing a guessing game. Sponsors have a hard time finding sites that can successfully take on their studies and recruit an adequate number of participants, largely due to inaccurate enrollment numbers from the sites. They’re required to choose sites based on loose estimates. Conversely, sites struggle to predict accurate enrollment numbers due to a lack of necessary information from sponsors, particularly when all they have is a synopsis of the study. Without inclusion/exclusion criteria, determining potential enrollment becomes an educated guess. This vicious cycle of miscommunication leads to wasted resources and underperforming clinical trials from the very beginning.
Communication often continues to be a problem throughout the course of a study. Sites and sponsors still struggle to communicate the necessary information to determine feasibility, activate studies, accrue participants and much more. Without real-time visibility into study status and trial conduct, sponsors rely on sites and CROs to communicate trial progress. This chain of communication can often act as a hurdle to understanding how a trial is doing and what the site needs to address potential problems, yet sponsors still rely on this ineffective chain of communication to assess site performance.
Research sites use multiple systems to streamline different parts of the clinical trial process and collect, manage and report on clinical operational and trial data across their enterprise. Systems such as electronic medical record systems (EMRs), clinical trial management systems (CTMS), electronic regulatory (eReg) systems and general ledger (GL) systems act as the source of truth for this clinical operational and trial data. However, there’s currently no way for sites to share this valuable information with sponsors. Instead, sponsors are left to use spreadsheets that are manually updated by monitors to keep track of participant accruals and other study conduct.
While electronic data capture (EDC) systems are a solution for sponsors to get the data they need from the sites, having to use a different EDC system for each sponsor a site works with becomes a challenge in itself. Between their EMR, source documentation system and the sponsor’s EDC, sites often perform triplicate data entry, multiplied by the number of studies they’re conducting at a given time. Using so many different systems both increases the chances for data entry error and puts significant administrative burden on the site. Current efforts in the clinical research industry are focused on a per protocol approach for transfer of eSource to sponsors, sacrificing the efficiencies that could be gained by sharing information from the enterprise-wide systems sites are already using.
Envision a two-sided network, where systems used to collect clinical data and optimize research performance are connected and channel information to each stakeholder for more efficient and higher quality clinical trials. Imagine a clinical trial ecosystem where the exchange of information between sites and sponsors is seamless, and all stakeholders have the information they need without increased administrative burden. In this connected ecosystem, site selection and feasibility would no longer require guesswork, both sites and sponsors would have real-time visibility into trial progress and performance and duplicate data entry would be significantly reduced. It would be the prescription for the research industry’s ailment.
At Forte, we’re actively working towards making this seamless data exchange a reality. Attend my session at the 2018 Society of Clinical Data Management’s Annual Conference to hear more about Forte’s initiative, DIRECT (Digital Research through Connected Technology).