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European Biopharmaceutical Review

Digital Exchange

New studies show the benefits of web-based clinical document communication tools and suggest that sponsors and CROs should consider investigator sites’ needs and the clinical community perspective as they deploy clinical trials in order to ultimately gain a competitive advantage.

Biopharmaceutical companies are constantly being challenged to streamline their clinical trial processes to meet rigid timelines, rein in rising costs and ultimately bring meaningful therapies to a hyper-competitive marketplace (1). Although electronic solutions have been playing a larger role in improving clinical trial operations, document exchange is one activity that remains a largely inefficient, unsecured activity (2,3). It is often a paper-clogged process that contributes to clinical trial delays, which research suggests is a problem faced by nearly half of all studies (4). This article presents the results of a recent online survey of 598 global investigative sites, which documents

a heavy reliance on traditional methods of document exchange during clinical trials, such as email, courier and fax (5). As studies become more complex due to challenging protocols, a narrowing in the definition of the inclusion/exclusion criteria, the effects of globalisation and the use of more sites per new drug application (NDA), the number of documents to be exchanged among stakeholders is growing, creating more bottlenecks (6,7). These realities are reflected in two key themes from the study: current methods of document exchange are too time-consuming and they do not provide actionable insight.

One of the more interesting findings is a definite willingness – even an eagerness on the part of investigators and clinical research coordinators – to improve their operations so that they can become higher performing sites. Respondents state that they would be willing to utilise web-based document exchange to improve processes. Specifically, 68 per cent responded that being able to access updated information right away would be a major advantage.

These survey results offer important insights for the sponsor and the contract research organisation (CRO). The fact that sites are anxious to improve their performance by knowing where the correct documents are and what actions need to be taken will facilitate their ability to stay on track and accelerate cycle times. At the same time, the clinical research team will benefit by having actionable information sooner, allowing for better and faster decision-making.

The Survey

CenterWatch, in conjunction with an industry provider, conducted an online survey in May 2011. Its purpose was to identify methods currently used in clinical trials for document exchange and gain a better understanding of the effectiveness of those methods.

The survey yielded 598 respondents across the globe (see Figure 1), with most identifying themselves as clinical research coordinators (58 per cent), followed by the second most common identification of either a principal investigator (21 per cent) and sub-investigator (4 per cent). The remaining 17 per cent were largely study monitors and others at the site including administrative types. This was an experienced group, with 87 per cent reported having conducted at least three studies over the previous 12 months, and nine per cent having conducted more than 15 (see Figure 2). The major finding of the survey is that 73 per cent of respondents continue to use unsecure and often manual methods for document exchange, namely email, courier and fax (see Table 1). Twenty-five per cent claim to use web-based methods. The fact that nearly three-quarters of respondents rely on inefficient methods that lack electronic audit trails or version control translates into a lot of time being wasted on tasks such as tracking due dates, searching for documents and ensuring receipt of the correct version of the documents by the correct individual. As evidence of the inefficiencies inherent in traditional methods, survey respondents revealed the following:

  • 74 per cent report resending documents to sponsors and CROs at least once or twice, and in some cases, more than five times a week
  • 66 per cent spend at least two hours, and in some cases more than nine hours, per week searching for documents
  • 59 per cent track due dates for information, current status or milestones manually, using tools such as paper calendars, white boards or to-do lists

To lend a sense of magnitude to these findings, sites tend to be involved in multiple studies simultaneously, each with a host of documents to be exchanged, such as the protocol, site feasibility form, investigator brochure, budget worksheet, site contract, and the informed consent form. More than half of the respondents (57 per cent) are participating in at least four concurrent studies, with some performing more than 15 (see Figure 3). Without a meaningful way to exchange documents easily, quickly, and securely, this becomes a major effort, stealing time from other more valuable activities, such as treating study volunteers or recruiting more patients.

Importantly, respondents express a strong willingness to try electronic document exchange systems and recognition of the value these systems can bring to the clinical trial process. As mentioned previously, 68 per cent of the respondents said that access to updated information on the spot, as well as the reduction in the amount of paper they use, were advantages. Also, 62 per cent stated that being able to keep track of information easily was beneficial and 47 per cent reported that they would expect to spend less time searching for information. Finally, 40 per cent indicated that they did not have any concerns about using an online tool for study document exchange.

Advantages of Listening to the Investigator

Survey results indicate that end-users of clinical trial systems, namely clinical research coordinators and investigators, want to improve their operational efficiency and trial performance. Based in the trenches every day, they have first-hand experience and good insight into solutions that can help make the clinical trial process more efficient. Furthermore, sites have expressed little resistance to adopting web-based technologies that can simplify their job by offering transparency and access to information right away, which ultimately improves performance.

Listening to sites and viewing them as a valued part of a clinical trials community that includes the sponsor, CRO and the institutional review board (IRB)/ethics committee (EC) is a holistic approach that can serve to increase operational efficiencies for all as more sponsors adopt web-based document exchange. In the past, little consideration has been given to whether web-based solutions were user-friendly or whether end-users could easily find the documents they were looking for. One industry provider recently reported that an end-user can spend up to 10 minutes searching on a company portal for a single document that needs attention (8). Furthermore, sites have found that some common sense functions for streamlining the process – such as sending an alert to the investigator’s email and explaining which actions need to be taken – are often lacking.

However, changes are underway. Forward-looking biopharmaceutical companies are realising that if sites gain more efficiencies and insight from a web-based document exchange solution, the entire clinical research team sees the benefits. As part of this process, research suggests that sponsors have been exploring the subject of how to make sites perform better and it seems that those interested in collaborating and improving communication are on the right track (9,10). The overall goal is to improve performance by accelerating cycle time for site startup, speeding distribution of non-static documents such as protocol amendments and revised informed consent forms, and expediting safety reporting. The latter is garnering particular attention with new guidance from both the European Medicines Agency (EMA) and the Food and Drug Adminstration (FDA).

For the clinical research team, improving site performance is a critical factor in better control of timelines and the continuing rise in clinical trial costs. According to a recent study, there are several factors driving higher costs, namely growing competition for the limited number of high performing sites, increases in the number of clinical research associates per study, and higher costs per patient (11). Phase 3a costs, for example, have jumped from $25,280 per patient in 2008 to $47,523 in 2011, and Phase 3b costs have leapt from $25,707 to $47,095 over the same time period. Other phases are experiencing similar rises, motivating sponsors to seek solutions.

Looking Ahead

Results from the online document exchange survey are an important bellwether for the clinical trial community. They not only confirm that document exchange continues to be a mostly inefficient and unsecure process without actionable insight, they also highlight a real desire on the part of site personnel to make meaningful changes to the traditional methods that slow studies, create frustration, and throw timelines off course.

Fortunately, sponsors are looking to address this issue by creating a community with investigators and other stakeholders as they implement web-based document exchange solutions. Engaging the sites in a transparent process that provides an overview of the status of various documents allows for reduced cycle times and faster decision-making based on actionable information – a win-win formula for the clinical research team.

References

  1. Bianchi A, Clinical operations: Benchmarking per-patient trial costs, staffing and adaptive design, Cutting Edge Information: p174, 2011
  2. Louie AS, US electronic data capture 2007-2012 spending forecast and analysis, Health Industry Insights, 2009
  3. Connor C, Electronic data capture is on the way up, Health Industry Insights, Clinical Development Strategy and Technology Marketplace, Next Generation Pharmaceutical, October 2007
  4. Boericke K and Gwinn B, Planned to perfection, International Clinical Trials: pp27-30, August 2010
  5. IntraLinks Global Investigator Site Survey: results highlight need for the adoption of web-based clinical trial document exchange tools to drive efficiencies and increase productivity, Press release, 14 June 2011
  6. Getz KA, Rising protocol complexity, execution burden varies widely by phase and TA, Tufts Center for the Study of Drug Development, Impact Report, May/June 2010
  7. Getz KA, The elusive sponsor-site relationship, Applied Clinical Trials, 1 February 2009
  8. Bowers L, Next generation of clinical trial portals: Building communities, IntraLinks Blog, 7 June 2011, http:// intralinks.com/blog/2011/06/07/ next-generation-clinical-trial-portalsbuilding- communities
  9. Lamberti MJ, Zuckerman R, Howe D, Shapiro L and Getz KA, Factors influencing investigate site willingness and ability to participate in clinical trials, Drug Information Journal 45: pp377-390, May 2011
  10. Harper B and Neuer A, Good site and sponsor relationships pay off, Applied Clinical Trials, January 2008
  11. Silverman E, Clinical trial costs are rapidly rising, Pharmalot, 26 July 2011, www.pharmalot.com/2011/07/ clinical-trial-costs-for-each-patientrose- rapidly

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Linda Bowers is Vice President of Life Sciences Product Marketing at IntraLinks. Linda is responsible for building on IntraLinks’ position as the leading software-as-a-service solution for critical information exchange in the life sciences industry, working closely with industry leaders to understand market trends, market problems and industry drivers to impact product strategy and direction at IntraLinks. Linda’s background includes 20 years of experience in the healthcare, life sciences and technology industry and prior to IntraLinks was Senior Director, global life sciences industry solution management at SAP Labs, LLC. Linda holds an MBA from Simmons School of Management, with highest honours and a BA in Molecular Biology from Wellesley College. Email: info@intralinks.com
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