Elderly, children, people with disabilities, and everyone in between can use eCOA more effectively than paper in a clinical trial. Jery Grupp discusses why eCOA is preferred by sponsors due to its unique features.
It’s an interesting question when people ask, does eCOA support special populations better than paper. Some of the challenges in paper are positional. That if you have the diary and you have to write on it, you have to support it—how do you—where do you put it, how do you write on it, and if you’re out in public how do you prepare a diary. There are certain therapeutic areas where someone might actually be embarrassed or reluctant to perform something with handwriting. Ah, someone with a mobility impairment or a stability impairment—maybe such as Parkinson’s—for them to mark on a diary or to write a number on a diary might be very difficult and might also lead to later interpretation problems for data entry. With an electronic diary, we’re not asking for handwriting. You can use your fingertip, you can use your knuckle, we often provide a stylus if that makes people more comfortable. And we used something called spinners, which is if you’re entering a temperature, you’re actually—you can use your knuckle and you can bump the thing a few times to change the numbers up or down until they’re right. And when they’re right, push the button to commit them. Once you’ve written on paper, it’s written, even if you didn't mean to mark it. And that’s one aspect. The second thing is, social acceptability. When you pull out a piece of paper to make a note about something, people in public may look at that and wonder what that is. I don’t think people think twice in this day and age when someone pulls out a small phone out of their pocket, looks at it, touches the screen a few times, and puts it away. I don’t think they think twice about what is that. And so you may be in a population where it might be embarrassing to see someone pulling out a diary, a piece of paper, a notebook, to make a recording of something. It might be a topic of discussion they don’t want to bring up. In our environment this day and age, that’s not a real issue when you’re using an eDiary.
About the Author
Jery has almost three decades of clinical research experience. For 16 years Jery was responsible for the assessment, selection, integration or creation of new technology at major pharmaceutical companies. For the past 10 years he has been providing clinical trial technology solutions that answer clients’ needs and enhance the quality and efficiency of their operations. Jery’s work prior to pharma includes commercial banking, insurance, and consumer products. In addition to his expertise in ePRO and eCOA, Jery is familiar with many other new and innovative technologies. Jery has served in many roles within the clinical industry, including Director of Project and Trials Management, Client Relations Director and VP of Quality and Regulatory. Outside of the office, Jery’s public service has included providing emergency medical coverage to his community, advocating for persons with disabilities and for the last 18 years serving as an elected school board director for one of Pennsylvania’s largest public school districts, where Jery is now the President of that board.More Content by Jerold Grupp