By Ann Neuer 

May 21, 2012 | The tedious process of building an electronic clinical trial is a stubborn bottleneck requiring too much time and too many resources. Those are the topline results of a 2011 survey conducted at two annual meetings—the Drug Information Association (DIA) and the Society for Clinical Data Management (SCDM). Cmed Technology, a UK-based provider of eClinical solutions developed and administered the survey, which resulted in 87 respondents from 55 companies. To get unbiased results and to focus on those with knowledge of what it takes to build an electronic clinical trial, Cmed eliminated respondents who identified themselves as sales people or employees or customers of Cmed.  

Survey results supported the widely held notion that building an electronic clinical trial is a lengthy process, but what was surprising was how long it actually takes. “We asked about all four phases of clinical research, and no one—literally zero—reported building a trial in less than two weeks. This takes into account the fact that Phase I trials often take only a few weeks to conduct,” says Jim Haughwout, vice president of product, marketing and sales at Cmed.  

According to the survey, 35% of electronic trials require more than eight weeks to build, and nearly two-thirds take six weeks or longer. Some 40% of Phase II and Phase III trials needed more than eight weeks to build, with a few spiralling upwards to 26 weeks.   

The survey pinpointed many challenges that contribute to the slow process. The two most frequently cited obstacles were “they take too long (33%)”, and “they require too much technical knowledge (28%).” Tied for third place at 19% each were “it’s too complicated” and “they don’t sufficiently comply with standards.”   

These responses came not from clinical types with little IT experience, but rather from people with strong technical backgrounds. The most common job title, representing 35 respondents, was “EDC programmer”, followed by 32 respondents who identified themselves as data managers, directors of data management, or vice presidents of data management. They also came from an array of companies large and small, including pharmaceutical sponsors (53%), contract research organizations (CROs) (18%), academic medical centers (10%), and other categories.   

Haughwout says the impetus behind the survey was his frequent discussions with clinical trial professionals across the globe bemoaning the challenges in building electronic clinical trials. “Whether I was in Brussels, attending a meeting, or visiting with big pharma, I kept hearing the same thing, that the whole process of setting up a trial takes far too long, it always runs late and it’s a complicated process. Being in a data-driven industry like we are, we wanted to get a bit more insight.”  

Speeding and facilitating the building of electronic clinical trials are desirable industry goals meant to address a continuing dilemma in the industry: If it takes eight weeks to build a six-week trial, what are the trial builder’s choices? “He or she can start building eight weeks in advance, before the protocol is approved, meaning that once it is approved, there will be last minute changes, which extends the amount of time needed to build the trial, essentially wasting some of the time already spent,” Haughwout explains. “The other choice is to wait until the protocol is final, knowing there are no changes. But by that time, the trial may be well underway because the sponsor generally doesn’t want to delay the start of patient recruitment.” 

Many sites are finding themselves in this situation of having to start a trial that is incompletely built and then, several weeks later, once the trial building is finished, they have to go back and retrofit the data into the newly completed forms. 

To address some of these challenges, Cmed released Timaeus Guided Trial Builder (GTB) in 2011, which is intended to simplify and streamline the work required to start up electronic trials with full adherence to required standards.  The goal of GTB is to take out the complexity and heavy lifting by allowing people to use off-the-shelf tools for technical and clinical factors, and eliminate the many hand-offs back and forth between the study manager, product manager, and programmer.   

“A few years ago, I saw a diagram of the number of hand-offs required for development and programming of a case report form (CRF), and it looked like a spider web,” Haughwout says. “If you can cut that out, you can save an enormous amount of time and money for companies of all sizes.”