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. 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. 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.
This article describes how the need for an improved SSU process is gaining traction. Using cloud-based technology, a better SSU methodology aligns with the goal of faster development by significantly impacting cycle times. This approach leads to greater cost savings and faster market entry, making valuable therapies available to patients sooner.
► About Study Startup (SSU)
Daily 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. To confront these issues of cost and time, the industry has been evolving from its slow paper-based methods toward cloud-based systems. 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.
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. These factors, plus poor case report form design, lack of recruitment planning, and not initiating sites in a timely fashion all contribute to delays. Moreover, a 2014 report funded by the U.S. 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.
To confront SSU issues in a way that engages clinical trial stakeholders, a collaborative approach has been deemed essential. One of the early research efforts was funded by the U.S. Food and Drug Administration and undertaken by the Clinical Trial Transformation Initiative (CTTI). That work identified seven SSU cycle times of interest (Chart 1), and concluded that many stakeholders in the U.S. clinical trial enterprise routinely fail to collect standardized measures of SSU cycle times, a practice that is common in many industries.
► A Better Process
There are numerous challenges posed by the many steps involved in SSU, making study delay highly probable from the outset. 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. As a result, time is wasted in status meetings, as the desired information is not readily available. 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. 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. 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.
With the advent of purpose-built SSU solutions, real-time viewing of data and smart workflows that standardize processes becomes possible. 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). It is designed to provide better collaboration with sites and improve business processes (Chart 2). 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.
Collectively, these benefits are major timesavers in site activation. As evidence, a major pharmaceutical company used an SSU in all of its U.S. sites that conduct oncology trials. Prior to the implementation, the company relied heavily on manual spreadsheets for progress reports, and had no view of work in progress or real-time study startup status. After an eight-month implementation, the company experienced a 32 percent reduction (in weeks) in SSU. This included receiving essential documents from sites in 17 weeks instead of 30, and completing contracts and budgets in 3.5 weeks instead of 4.2 weeks.
Many of the steps involved in SSU create delays, but the advent of purpose-built cloud-based technology can make a disruptive impact. An SSU application is a critical additional to the ongoing automation of clinical trials, and has the promise of cutting costs by shortening timeframes for developing therapies needed by patients worldwide.
Jae Chung is the founding visionary of goBalto. A startup evangelist, he works with Rock Health to mentor healthcare technology startups. He previously co-founded Celltrion, a leading biopharmaceutical manufacturing company and was a strategy consultant with McKinsey & Company.