Investigator Site Survey: Results Indicate Strong Appetite to Significantly Improve Efficiency with Web-based Clinical Document Exchange Tools
IntraLinks conducted the “IntraLinks Global Investigator Site Survey” last month to better understand how investigative sites manage the clinical trial document exchange process with sponsors and clinical research organizations (CROs), and to gain a better understanding of the challenges of using paper-based methods. The survey results ultimately revealed a significant opportunity for investigator sites to improve efficiency through web-based solutions for clinical trial document exchange.
A considerable majority of the survey respondents, 73%, still use traditional methods (e-mail, courier, fax) as their primary means for clinical trial document exchange. E-mail usage rates ranked the highest, while courier and fax usage were less prevalent (but still used) as the main way for exchanging clinical trial documents. Adoption of electronic tools has grown, yet these methods continue to fall short in addressing the current document exchange needs at most clinical trial sites.
Key themes that stand out regarding the typical issues with these traditional methods include that they are too time consuming and don’t provide actionable insight, which results in less ability to understand the status of information and when to take action or make decisions. Fifty nine percent of respondents manually track due dates for information, current status or milestones using, for example, white boards, paper calendars and to-do lists. Sixty six percent of respondents spend at least two hours, and in some cases more than nine hours, per week searching for documents. Almost 75% respondents report resending documents to sponsors and CROs at least once or twice a week
Surveyed sites responded that the anticipated benefits of using a web-based document exchange tool would help address the current inefficiencies and that there were few anticipated downsides. More than two-thirds of respondents cited being able to access updated information right away as well as reduce the amount of paper they use as advantages. Sixty two percent cited being able to keep track of information easily and almost 50% of respondents reported that they expected to spend less time searching for information. There was an overall willingness to leverage online tools for study document exchange, including additional surveys that are commonly used.
The survey reinforced that it is pivotal to consider the voice of the investigator, especially at high performing sites, in planning and deploying web-based clinical document exchange tools to reach optimal productivity gains and efficiencies. Eighty seven percent of respondents have conducted three to 15+ studies over the last 12 months and 57% of respondents are running four to 15+ concurrent studies. Further, the respondents are not strangers to web based clinical tools — 47% have at least 3-10 logins and password, while another 20% have more than ten.
Overall the survey demonstrates that sites are thirsty for additional ways to optimize their operational efficiency and gain actionable insight in a simple, easy to use, streamlined fashion.
There needs to be a paradigm shift to evaluate clinical document exchange challenges from a clinical community perspective, i.e. Sponsor, CRO, Investigator Site, IRB/ECs. There are early indications that sponsors/CROs seem to be willing to take a holistic approach, and look beyond their own perspective. Leveraging a community-based solution, where all clinical community members have transparency and actionable insight using a web based solution that reduces the burden of training, support and passwords would be a win-win proposition.
I look forward to further discussing the survey findings at the DIA Annual Meeting in Chicago next week.