Clinical trial researchers and research coordinators are burned out. No wonder – we’re three years into the COVID-19 pandemic, an event that had a direct impact on clinical research. Many trials were halted or suspended, and resources were refocused around therapies and solutions to address the rapidly growing public health crisis. As of September 2020, around 1,000 organizations reported trial disruptions across more than 1,200 trials. The lifting of trial suspensions, which began in the summer of 2020, and the desire to try to make up for lost time undoubtedly created additional stress for clinical researchers.
Adding to the chaos is the large volume of new safety protocols and new clinical trials for COVID-19; trials which were conceived on an accelerated basis under initiatives such Operation Warp Speed, a government program created in early 2020 to compress the traditional clinical trial process, as well as numerous other public and private programs trying to do their part to get a handle on COVID-19. In fact, since the pandemic began, more than 3,300 COVID-19-related clinical studies have been completed and another 5,000+ were initiated.
Clearly, while stress levels were high even before COVID-19, many of the disruptions the pandemic caused are still with us today. Hospitals and clinics have increased safety and administration protocols, staffing levels are low and participants are hard to come by.
A rising trend of researcher dissatisfaction and turnover
Even before the pandemic, the majority of clinical research coordinators (86 percent) experienced work distress. The primary causes of stress were employment contract type between researcher and site (31 percent), workload (21 percent) and lack of skills recognition (18 percent). More than 30 percent said they experience stress because of strict requirements in sponsor contracts. Nearly 68 percent said stress adversely affected work performance and 74 percent were considering a job change.
Ongoing stress leads to job dissatisfaction and high turnover. A 2020/21 study found the average annual turnover rate for clinical research associates (CRAs) was 30 percent. By comparison, the overall turnover rate for workers in America is around 19 percent. There is some evidence the pandemic negatively influenced the turnover rate. In a 2022 OpenClinica study, Impact of Satisfaction and Burnout Among Clinical Researchers, 52 percent of site respondents reported a higher turnover rate than before 2020 and a strong majority (61 percent) of all research staff said they are completely or somewhat burned out.
The same OpenClinica study asked how much time does your clinical team spend on manual data transcription. Among respondents, 60 percent admitted to spending two hours or more per patient per day transcribing data from the electronic health record (EHR) into the clinical trial electronic data capture (EDC) system:
Under 1 Hour 5 percent
1 Hour 15 percent
2 Hours 31 percent
2+ Hours 29 percent
I don’t know 19 percent
Researchers look to technology for help
Two-thirds of sites surveyed (66 percent) believe an investment in technology will accelerate clinical research. It also can reduce the burden of manual data transcription, alleviating a source of continual frustration for CRCs and sponsors.
An innovative solution to this problem allows researchers to sidestep manual data transcription altogether. By digitally accessing source data directly from patient health records (e.g. an EHR system) sites are able to automatically populate the trial EDC and electronic case report forms (eCRFs). Automated data capture through EHR-to-EDC integration in this way benefits both CRCs and sponsors, delivering:
- Better site relationships as data entry burden lessons.
- Faster access to finalized data.
- Lower costs through efficiencies and decrease of source data verification (SDV) – a manual data-checking process which adds weeks or months to a clinical trial.
In all, there are eight distinct advantages that EHR-to-EDC connectivity provides:
- Speed: Sponsors conclude trials faster.
- Representation: Easier access to trials by more diverse populations.
- Patient Centricity: Focus on patients, not paperwork.
- Digital Insights: Decision-making confidence.
- Data Quality: Reduce manually-introduced errors.
- Cost Reduction: Reduce SDV; re-useability across multiple sites.
- Site Satisfaction: Lowered overall workload for site staff.
- Multiple Applications: Adaptability to all trial types.
To learn more, including the three trends leading to greater adoption of EHR integration, download our playbook, Fast-tracking clinical trials with automated source data capture.