Emphasizing ‘Solutions’ in eClinical Tools for Sites

On average, investigative sites are managing a dozen different systems provided by sponsors, contract research organizations (CROs), and vendors to collect and capture clinical study data. These systems-a mix of mature and nascent tools-are not integrated, they are incompatible, they are increasing investigative site workload, and, according to principal investigators and study

Ken Getz

coordinators, they are contributing to study conduct inefficiencies and lower productivity.

A new CenterWatch study shows that investigative sites are being inundated with a growing number of eClinical technologies. The large number of disparate and incompatible solutions has left many sites feeling that they are, at best, an afterthought in the design of eClinical technology functions and uses. 

The survey was conducted online between January and March 2016 in collaboration with the Association of Clinical Research Professionals (ACRP). In addition to the large average number of systems used, investigative sites report routinely using an average of 10 software applications simultaneously to manage their clinical studies, each requiring unique login instructions and training.

Increased burden and potential for errors

Despite the best of intentions, technology solutions implemented at investigative sites frequently have the opposite effect to which they were intended: the solutions create additional work since information from patient visits and laboratory tests must be transcribed from paper or electronic sources manually into study software.  

Technology solutions implementation and ongoing support also largely falls on study staff. As the number of solutions has grown, particularly interactive and mobile technologies used by patients, study staff must frequently act as the “Help Desk” while communicating with a large number of third-party vendors for technical assistance.

The majority-80%-of investigative sites report using electronic data capture (EDC) and electronic case report form (eCRF) technologies. More than half of sites report using interactive voice and web response systems, (IVRS/IWRS), clinical web portals, safety and adverse event reporting technology, and clinical trial management system (CTMS) and electronic patient reported outcome (ePRO) systems. Other technologies employed less often include learning management systems (LMS), electronic trial master files (eTMF), and ePRO platforms that use a patient’s own smartphone or tablet. 

Although EDC was widely adopted more than a decade ago, investigators and study coordinators continue to record patient study-visit information on paper and then re-enter the source data into electronic data capture and management systems. Patient information stored in the site’s own CTMS or electronic medical record (EMR) software is typically printed out and manually transcribed into clinical trial software systems. Since various systems seldom have the ability to integrate, patient data often must be entered into several different electronic systems-such as EDC, IVRS/IWRS, ePRO or an investigator portal-for the same study. 

eClinical solutions also appear to be complicating procedures and poor interoperability requires using antiquated and new technologies simultaneously. Laboratory reports, for example, are sent to investigators for review either by fax-which requires sites to maintain facsimile machines and traditional landlines-or through Internet portals. In turn, study staff typically needs to manually enter information from the reports, along with evidence that they have been reviewed by the principal investigator, into EDC or other software systems. 

Study coordinators also report that electronic systems require continual monitoring to locate copies of new laboratory reports, such as results from electrocardiogram (ECG) tests. Further compounding the challenge, investigative site staff must juggle the use of disparate solutions while under tight deadlines.

The need to transcribe source documents and patient information into electronic systems not-only duplicates effort, it also increases the possibility of transcription errors. And many sites report interacting with a large number of third-party solutions providers who often fail to identify themselves and the specific solution that they are supporting and upgrading. 

Study staff must devote additional time to ensure that these vendor solicitations are legitimate. Responding to fraudulent technology vendor solicitations could have disastrous consequences.

A sea of login and training requirements

In every eClinical solutions category-EDC, eCRF, CTMS, and Internet portals, for example-investigative sites must manage software from multiple vendors. These systems each require a unique username and password, which typically must be changed every three months for security reasons. Nearly three-fourths (74%) of study staff report that keeping track of multiple usernames and passwords is a top challenge. 

High-volume investigative sites report routinely maintaining login information for at least 40 or 50 systems. Study staff use a variety of methods-some progressive (use of secure software), some very rudimentary (notebooks and paper forms)-to remember login instructions and passwords. Many large sites have dedicated staff to oversee the management and protection of passwords and a process for changing and updating them. 

Sites express considerable frustration over technology solutions training requirements. Four-out-of-10 investigative sites surveyed indicate that too much technology training is required. And an overwhelming majority (95%) of sites believes that training contains repetitive elements. Most sites report that sponsors and CROs typically force sites to repeat training activity despite the clinical study staff having experience and prior training on certain technology solutions. 

Unmet site technology needs: A major opportunity

As sponsors and CROs look to more firmly establish themselves as partners-of-choice with investigative sites, there is much room for improvement.

Sponsors, CROs, and eClinical solution providers continue to develop and implement point-based solutions that bombard and over-burden investigative sites. The CenterWatch study points to the urgent need to rethink this top-down approach and to build investigative site operating experience and requirements in at the outset. Investigative sites want technology systems that are interoperable and that demonstrate a deeper understanding of site and study workflow. 

More than a quarter (28%) of sites surveyed want the biopharma industry to adopt a single common technology platform. Investigative sites also want sponsor organizations and CROs to reduce redundant training requirements by accepting proof of prior training.

Electronic source data promises to play a particularly important role in driving study conduct efficiency. With eSource, data obtained during each study visit or during participation can be entered directly, eliminating the need for duplicate data entry into EDC systems. And interest in eSource is gaining momentum since the FDA issued guidance in 2013 encouraging its use. 

Sponsors are increasingly looking for technologies to gather more data to support real-time monitoring of clinical study progress and enrollment performance. The adoption of new technology solutions will no doubt continue. 

Based on investigative site feedback, however, the most useful and valuable technology solutions are not those that introduce disparate functionality. They are those that reflect a deep understanding of site workflow, that are interoperable and that integrate with other systems and processes. Ultimately, technology solutions that optimize site performance are the ones poised to deliver on the promise of speed and efficiency while meeting the priority objective of supporting higher levels of study volunteer engagement.

Kenneth A. Getz, MBA, is the Director of Sponsored Research at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, e-mail: kenneth.getz@tufts.edu