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Applied Clinical Trials
Today's CRAs must redefine their roles in the face of changing industry expectations and new technologies.
Based on recent interactions with pharmaceutical, biotechnology, and CRO companies, it appears that the role of the clinical research associate (CRA) is undergoing intense examination and revision, driven largely by the adoption of e-clinical technologies and new study conduct practices. Several companies have noted the transition of their CRAs into data managers with an increasing amount of their administrative activities handled by electronic technology solutions. But mounting study conduct performance pressures during the past five to seven years are also pushing CRAs to redefine their roles all together: from monitor and taskmaster to trainer, helpdesk, and active site collaborator and motivator. Communication, e-technology savvy, and interpersonal skills have never been more critical to CRA effectiveness.
Kenneth A. Getz
Companies' expectations of CRAs have changed in several tangible ways. Standard operating procedures (SOPs) today, for example, tend to give CRAs less time to visit and to follow up with investigative sites. SOPs also require more detailed documentation of monitoring activities, including more elaborate enumeration of items contained in study binders.
"CRAs across the board have been working longer hours than they did before 9/11, largely as a result of increased airport security," added Lorry Witte, RN, BA, CCRA, CCRC, a Twin Cities, MN-based study monitor. "Yet the pressure to beat deadlines is as tight as it has ever been, requiring CRAs to spend more time working on laptops in airplanes and in hotels and airports."
The New ABCs for CRAs
Heavy travel burdens, rising airline-related costs, and delays have prompted many companies to decentralize CRA functions, including creating regional CRA positions and limiting travel within specific territories. "Regional CRAs, on average, spend 60% to 80% of their time traveling. But many now stay in the same time zone, so there are less connection issues and it's quicker and easier to get where they need to go," explained Sandra O'Donnell, MA, MT (ASCP), CCRA, senior regional CRA for ZARS Pharma.
New regional positions can significantly reduce overhead costs. According to CRA managers in several major pharmaceutical companies, a large percentage of regional CRAs operate out of home offices. Doing so means, however, that CRAs need to be even more computer-savvy than their office-based counterparts because the bulk of communications and training happens electronically. It also means telephone and e-mail messages have to be more skillfully composed and delivered to prevent miscommunication.
On the regulatory front, CRAs need to be prepared for more comprehensive tracking of protocol deviations and adverse events observed in new source documentation formats. "Clinical trial teams must decide upfront and agree with health authorities on what constitutes source documentation on studies involving remote data transfer, machines with memory, and patient reported outcomes," said Giovanni Della Cioppa, head of methodology and innovation in development at Novartis. "It's not always clear. But if it is not obvious and if the clinical teams don't spell it out, CRAs will each have their own view or they may not be prepared to track and report properly," he said.
Without a doubt, CRAs today need to be a lot savvier about information technology than most veteran study monitors ever anticipated. They also need to embrace more regular and formal means of communicating with study coordinators and investigators rather than through sticky notes and memos. "It has been a tough—and dramatic—transition for many paper loving CRAs," said Laurie A. Halloran, BSN, MS, CCRA, a Boston-based clinical trial consultant. "I have seen monitors who could only monitor if they printed out the entire electronic case report form [eCRF] on paper. But those days are pretty much gone at this point."
"Most CRAs, once they've done one trial using electronic data capture (EDC) never want to go back to paper. But study coordinators can be fiercely resistant, especially clinic nurses who aren't dedicated to research," said Minnesota-based CRA Witte. "To overcome the inertia, CRAs need to be contagiously enthusiastic about EDC. They also need to be proficient at using a variety of technology solutions if they are to champion speed-enhancing technology and troubleshoot with study coordinators," she said.
"Electronically-based source documentation is a huge driver of change for study monitors," said senior regional CRA O'Donnell. "We see many sites still habitually printing out all source documents because they don't know how to set the security level on the electronic medical records (EMRs) to limit data access only to what monitors actually need to see," O'Donnell said. "For privacy reasons alone, study staff may not be able to accommodate techno-phobic CRAs by printing out patient records much longer."
"CRAs not only have to have technological expertise but they must be more solutions oriented in their application of the technologies," said Halloran. "This is especially true when it comes to the problem of subject recruitment. It is no longer enough for study monitors to merely ask for enrollment head count. CRAs need to understand what attracts volunteers to a particular site or study. CRAs need to identify and to quickly react to participation barriers, such as transportation and the study visit schedule, which they often can do something about," she said.
Looking ahead, it's likely that CRAs will have to meet certain minimum qualifications to be a study monitor—be it certification or licensure. Many sponsor and CRO companies, at the moment, remain unconvinced that passing a certification exam means a study monitor is better qualified and thus deserving of higher pay. "Even the Association of Clinical Research Professionals (ACRP), the leading CRA certifier, is still trying to define what the minimum education and training requirements for study monitors ought to be," said Halloran.
Apparently, many CRAs are responding by seeking additional qualification from academic programs and advanced certification designations. "Certified CRAs go back for 24 credit hours of new learning every two years to retain their designation," said Witte. "But many are also looking to add new areas of qualification in study methods, for example, drug metabolism and regulatory, to set themselves apart."
"And this training is imperative because, ideally, CRAs are passing on some of that knowledge at every site visit," added Witte. "Monitoring has evolved into more of a collaborative effort with study coordinators and investigators to get the job done better. Increased regulatory scrutiny has demanded that those encounters happen more frequently."
"Increased use of technology, coupled with new clinical trial models, will eventually compel a new role definition for CRAs that includes greater IT knowledge and patient contact," predicted Novartis's Della Cioppa. "More and more, data will be transferred directly from the patient to the study database via portable devices and mobile phone technology. In terms of emphasis, CRAs in the future will move from raw data to the infrastructure that generates that data, including portable and patient-worn devices. They will need to ensure those devices are in order, those that break down are replaced, quality control is done, and that individual patients know how to use them."
There is wide consensus that the study monitor community will be populated with fewer but more productive, indispensable, and—presumably—better paid CRAs. They'll be the ones forging more effective relationships with investigative sites, setting the speed and tone at which a myriad of technologies and solutions are adopted during study conduct—arguably the most critical juncture in the drug development process.
"Given how far the CRA role has evolved to become more of a communicator and facilitator, CRA certification and training will need to distinguish between operational and scientific proficiency," added Della Cioppa. "But pharmaceutical companies can't do it all. I foresee the creation of a full university degree."
Demand for experienced CRAs continues to grow. Pharmaceutical and biotechnology companies are relying more heavily on their study monitors to address high levels of study conduct inefficiency, particularly among their North American and Western European investigative sites. Adding helpdesk and new communication and collaboration skills to their portfolio of responsibilities, CRAs hold the key to unlocking marked improvements in investigative site performance."
Kenneth A. Getz Kenneth A. Getz MS, MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, email: email@example.com