Biopharmaceutical companies are constantly being challenged to streamline their clinical trial processes to meet rigid timelines, rein in rising costs¹, and ultimately bring meaningful therapies to the hyper-competitive marketplace. Although electronic solutions have been playing a larger role in improving clinical trial operations^2,3, document exchange is one activity that remains a largely inefficient, unsecured activity.  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 studies⁴.

This article presents results of an online survey conducted by CenterWatch in May 2011, in conjunction with an industry provider, of 598 global investigative sites, the purpose of which was to look at methods currently used in clinical trials for document exchange and gain a better understanding of the effectiveness of those methods.

The Survey

The survey yielded 598 respondents across the globe: 70% were from North America, 21% from Europe, and 9% from Asia-Pacific. Most identified themselves as clinical research coordinators (58%), followed by principal investigators (21%) and sub-investigators (4%). The remaining 17% were largely study monitors and others at the site, including administrative types. Nearly 88% reported having conducted at least three studies during the previous 12 months, and 9% reported having conducted more than 15 (Figure 1).  

The major finding of the survey is that 73% of respondents continue to use unsecure and often manual methods for document exchange, namely e-mail, courier, and fax (Table 1).  One-quarter of respondents 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 wasted⁵. For example:

• 74% report resending documents to sponsors and CROs at least once or twice, and in some cases, more than five times a week
• 66% spend at least two hours, and in some cases, more than nine hours per week searching for documents
• 59% 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. More than half of the respondents (57%) are participating in at least four concurrent studies, with some performing more.  
Importantly, respondents expressed a strong willingness to try electronic document exchange systems and recognized the value these systems can bring to the clinical trial process.  For example, 68% of respondents cited being able to access updated information right away as well as reduction in the amount of paper they use as an advantages while 62% stated that being able to keep track of information easily was beneficial.

Gains by Listening to the Investigator

Survey results indicate that end-users of clinical trial systems, namely clinical research teams and investigators, want to improve their operational efficiency and trial performance.  Because they are in the trenches everyday, 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 and ultimately improve performance.  

Listening to sites and viewing them as a valued part of a clinical trials community 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 are looking for.

Changes are underway, however.  Forward-looking biopharmaceutical companies are realizing that if sites gain more efficiencies and insight from a Web-based document exchange solution, then the entire clinical research team sees benefits.  As part of this process, research suggests that sponsors have been exploring the subject of how to make sites more high performing⁶, and it seems that those interested in collaborating and improving communication⁷ are on the right track.  The overall goal is to improve performance by accelerating cycle time for site start-up, speeding distribution of non-static documents such as protocol amendments and revised informed consent forms, and expediting safety reporting.  

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 across all phases, 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 patient⁸.

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, but highlight a real desire on the part of site personnel to make meaningful changes.

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 winning formula for the clinical research team.  

References

1. Bianchi A. Clinical operations: Benchmarking per-patient trial costs, staffing and adaptive design. Cutting Edge Information, 2011. http://www.cuttingedgeinfo.com/research/clinical-development/trial-operations/, accessed August 11, 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, http://www.ngpharma.com/article/Electronic-data-capture-is-on-the-way-up/, accessed August 10, 2011.
4. Boericke K, Gwinn B. Planned to perfection. International Clinical Trials. August 2010;27-30, http://www.samedanltd.com/magazine/13/issue/134/article/2713, accessed August 5, 2011.
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.  June 14, 2011. http://intralinks.com/news-events/press-releases/2011/06/14/intralinks-global-investigator-site-survey-results, accessed August 5, 2011.
6. Lamberti MJ, Zuckerman R, Howe D, Shapiro L, Getz KA. Factors influencing investigate site willingness and ability to participate in clinical trials.  Drug Information Journal; (45):377-90, May 2011.
7. Harper B, Neuer A. Good site and sponsor relationships pay off. Applied Clinical Trials, January 2008. http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor+Articles/Good-Site-and-Sponsor-Relationships-Pay-Off/ArticleStandard/Article/detail/483705, accessed August 10, 2011.
8. Silverman E. Clinical trial costs are rapidly rising. Pharmalot, July 26, 2011. http://www.pharmalot.com/2011/07/clinical-trial-costs-for-each-patient-rose-rapidly/, accessed August 12, 2011

Paul Cofini is vice president, Life Sciences Product Management, at IntraLinks. He can be reached at [email protected].