Electronic data capture methods and technologies have been expected to empower more successful risk-based monitoring (RBM) strategies where study teams predict potential issues earlier and manage risk more efficiently. But despite the availability of these newer data technologies and the encouragement of regulators, many sponsors are managing their trial data in the same way. The goal of the July 17, 2019, Duke Margolis Center for Health Policy public meeting was to identify solutions for improving the implementation of RBM approaches within clinical studies. Listed below, you will find a few opportunities discussed in that meeting that sponsors can consider when planning and conducting RBM for their trials.
 
What is currently holding companies back from embracing RBM? Hesitancies to implement these technologies can vary, but most of this resistance can be attributed to worries of failure and resistance to change. Pharmaceutical companies, which can invest hundreds of thousands of dollars in a single drug, are concerned that by not reviewing 100% of their source data, they might miss something important and fail to get a drug approved. For these reasons, clinical research organizations (CROs) are not exploring alternatives. Today’s newest data management technologies, however, are solving some of the industry’s biggest problems but the lack of adoption is costing significant amounts of both time and money.
 
How have regulators encouraged new approaches?  Over the last decade, guidance has become available from the Food and Drug Administration (FDA) regarding the adoption of new strategies and approaches to research in general. The organization is pushing biopharma to adopt a risk-based approach to monitoring of clinical investigations. In fact, Scott Gottlieb, the 23^rd commissioner of the FDA, has been a longtime supporter of RBM to ensure safer, more efficient, and higher quality clinical research. In a recent statement, he explained:
 
“The FDA isn’t alone. The advent of precision medicine is challenging the entire medical research ecosystem to develop more efficient approaches to testing and developing diagnostics and therapeutics… including frameworks that are more carefully suited to the kinds of precision technologies that underpin new treatments.”
 
In general, the FDA is encouraging biopharma companies to adopt innovative research methods and drug development tools to reduce the cost and time of bringing new therapies to patients.
 
What tools and technologies are available that can help organizations embrace a comprehensive risk-based approach? With the ability to capture trial data at its inception, direct data capture (DDC) systems like eSource — which capture data directly from the patient — are eliminating the necessity of source document verification (SDV), and instead are making critical information available on demand. In turn, increased data accessibility is enabling CROs to conduct remote monitoring (remote source data review (SDR)) and embrace new study designs, like hybrid/virtual trials. From an RBM perspective, study teams can piece together a comprehensive picture of patient and study risk and follow up with critical decisions in real time. 
 
Despite these efficiencies, many are still committed to conventional oversight approaches, which are believed to have lower risk and be less subject to critical analysis by regulatory bodies. However, in order to effectively and efficiently streamline clinical trials, it is important we encourage sponsors and CROs to embrace the newest solutions for data management in RBM.
 
Those that have incorporated these tools are seeing benefits to their RBM strategies and the patient and site experience. Not only are organizations able to reduce site monitoring visit frequency, monitors are maximizing their time while focusing on aspects of their study that really matter — like patient safety, study drug and protocol compliance, and other more important aspects of the study. Additionally, this proactive approach allows study teams to properly manage risks from the very beginning, identifying them during protocol development and, for example, identifying, early on, which forms are required to be reviewed for every subject.
 
In addition to the uptick in the volume of electronic data generated for each trial, emerging study designs, regulatory guidance, and technology innovations are reshaping the role of clinical data management across the industry. As trials rely more and more on accessible quality data to make critical decisions, it is ever more important that good clinical data management practices are followed. Choosing the right tools and vendors are key to success.
 
Ensure that the company you choose captures data at its source and can work within the context of your RBM plan to implement a targeted and focused review of your study data at the transactional level. In addition to capturing data directly, your partner should help you eliminate redundant and unnecessary data review, and facilitate more focused site visits, and faster and more efficient critical decision making.

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As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s solution management and compliance teams to help sponsors and CROs better leverage eSource, eCOA, and ePRO data. With more than 20 years of experience, Andrus has extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution. At Clinical Ink, Andrus is responsible for P&L across Clinical Ink’s products and services, and he is also focused on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies, and clinical research professionals.