As evidence, a major pharmaceutical company used an SSU in all of its U.S. Furthermore, the application functions as a single repository for in-progress documents, information only needs to be entered once, and documents from the principal investigator’s database and the investigator portal can be accessed via a single logon.Ĭollectively, these benefits are major timesavers in site activation. It is designed to provide better collaboration with sites and improve business processes (Chart 2). Using an application program interface (API), the solution can integrate with other eClinical operations-the “clinical stack”-to optimize the clinical trial continuum by allowing information to flow among the various integrated components (Figure 1). With the advent of purpose-built SSU solutions, real-time viewing of data and smart workflows that standardize processes becomes possible. A 2014 survey conducted by Veeva Systems found that 21 percent of CROs and 15 percent of sponsors use an eTMF application, and a content management system is used by roughly one-third of sponsors and CROs. According to the 2013 Clinical Trial Management Systems Survey by eCliniqua and BioClinica, some 60 percent of respondents use digital software, such as CTMS, to manage clinical trials. Fortunately, these inefficiencies can be eliminated, as a purpose-built SSU solution becomes the missing piece in a world of electronic tools that have been widely adopted for more efficient study conduct. As a result, time is wasted in status meetings, as the desired information is not readily available. This issue is complicated by the fact that information used to launch clinical trials typically resides in multiple databases, and SSU tends to be conducted using Excel spreadsheets, e-mail, and shared file drives. There are numerous challenges posed by the many steps involved in SSU, making study delay highly probable from the outset. clinical trial enterprise routinely fail to collect standardized measures of SSU cycle times, a practice that is common in many industries. That work identified seven SSU cycle times of interest (Chart 1), and concluded that many stakeholders in the U.S. Food and Drug Administration and undertaken by the Clinical Trial Transformation Initiative (CTTI). One of the early research efforts was funded by the U.S. To confront SSU issues in a way that engages clinical trial stakeholders, a collaborative approach has been deemed essential. Department of Health and Human Services names sponsor-imposed barriers to SSU such as overly complex internal review methods and highly restrictive inclusion/exclusion criteria as further slowing the SSU process. Moreover, a 2014 report funded by the U.S. These factors, plus poor case report form design, lack of recruitment planning, and not initiating sites in a timely fashion all contribute to delays. There is no standard definition of SSU, but activities such as country selection, pre-study visits, site selection and initiation, regulatory document submission, contract and budget execution, and enrolling the first patient are typically cited. There has been a strong focus on study conduct, but as stakeholders are increasingly aware that better SSU processes are linked to shorter clinical timelines, the emphasis is shifting in that direction. To confront these issues of cost and time, the industry has been evolving from its slow paper-based methods toward cloud-based systems. This approach leads to greater cost savings and faster market entry, making valuable therapies available to patients sooner.ĭaily revenue lost because a drug is not yet on the market has been estimated in the range of $1 million to $8 million, and data from the Tufts CSDD indicate that mean clinical development time is 6.7 years. Using cloud-based technology, a better SSU methodology aligns with the goal of faster development by significantly impacting cycle times. This article describes how the need for an improved SSU process is gaining traction. According to the Tufts Center for the Study of Drug Development (CSDD), it takes eight months to move from pre-visit through site initiation, and the cost of initiating one site has been estimated at $20,000 to $30,000, plus another $1,500 per month to maintain site oversight. The current status of clinical trials has encouraged stakeholders to embrace cloud-based solutions such as clinical trial management systems (CTMS), and the electronic trial master file (eTMF), but one key bottleneck, study startup (SSU), has been largely overlooked. There is intense pressure to speed clinical trials and restrain costs, but inefficiencies tied to complicated protocols, globalization, and paper-based methods have stalled these efforts.
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