By Teri Crumb, MSN, RN, CCRC, TLC Research, LLC
There are many times I ponder what we could do better in clinical research. I find myself wondering about many different “what ifs.” Having been a clinical research professional (CRP) for almost 25 years, I have seen an amazing transformation in the management and treatment of various diseases, but there has been stagnation as well. Looking back, and at the same hoping for the future, I wonder:
What if research staff routinely appeared at clinics?
Let’s bring in a sponsor company’s research staff to talk to site staff and patients about research studies and what it takes to get involved. Wouldn’t this normalize clinical research participation? Wouldn’t this help develop trust between research staff and potential participants? Wouldn’t this promote recruitment and retention of participants? Education about clinical research trial participation and hearing from past participants about their experience may bridge the gap between knowing about research trials and offering to participate.
Research by Spaar et al suggests that providing a study nurse who regularly assists with recruitment activities may be a potential intervention for recruitment barriers.1 A nurse trained in clinical research can provide direct nursing care to research participants, educate patients about study participation as it relates to their specific clinical condition/disease that the study is addressing, as well as monitor for potential adverse events. The expertise that a nurse brings is clinical training, critical thinking, and leadership that would augment trial activities.
What if a sponsor consulted with clinical research coordinators (CRCs) when developing the protocol?
Would this help identify procedures or timelines that are unrealistic of sites or participants? Would this help find the right match of sites for a particular study? Years ago, one of my teams was evaluating a protocol for feasibility at our site. Our lead investigator was confident we could enroll the required patients. However, our team of CRCs raised concerns about the specificity of the inclusion/exclusion criteria and our ability to find patients who matched them. Despite this, our PI pushed ahead and took on the study. We never enrolled a single patient (which many sites struggle with, as well), and the sponsor shut down the study. Despite having done quite a few studies in this disease group, and as a CRP, my voice, and that of my team, was muted. I learned to speak up after that experience, to talk not just to the PI but to the sponsor and other research management staff when I had concerns. But imagine the time, effort, and money that could have been saved if decision makers listened to our concerns much earlier.
What if research staff received notifications from site technology when an eligible patient is seen in the clinic?
How would that impact our recruitment? Many EHRs have querying capabilities and report generators or alert notification functions, but how do research staff advocate to harness them? Searching through clinic schedules can be very time consuming for screening. Harnessing the data within an EHR could create a narrower list of potential participants based on things like condition, lab values, and prescribed medications.
However, pitfalls exist in harnessing this technology for participant identification, including access to EHR data, participant privacy and security, and the lack of standardization across systems.2 There is also a deeper concern related to the populations found within the EMR: Data is only from those who have access to the care system.
What if research coordinators received new protocol training with in-person meetings?
They could learn from others with diverse experience and knowledge. The training would include hands-on demonstrations of protocol required testing, EDC, and sample processing. It could provide GCP instruction as well as recruitment and retention guidance. With the incredible turnover in research staff over the last few years, many coordinators are very inexperienced and have received little training in their role.
A recent article by Maria Akhter describes in-person meetings as having higher engagement and productivity, fewer distractions, stronger team building, clearer goals, better collaboration, and an improved experience for attendees.3 I especially like her reference to feeling less isolated and more connected to others on the project. Aren’t these all great things for a trial?
Before the preference for digital tools and the swift uptake of them during the COVID-19 pandemic, research had identified several good reasons to conduct in-person meetings.4 Perks include being able to network and talk with more experienced clinical research professionals, establish relationships that improve communication during the trial, and the ability to openly discuss inclusion/exclusion criteria and the “why” of the study. I know that much of my formative training was through investigator meetings before clinical trials began. The wisdom that I gained from others helped me to set up the trial effectively. I also valued the one or two days dedicated to discussing our implementation plan with the PI because time is scarce and frequent interruptions halt deep conversation. Often our combined ideation gave us a great execution plan at the study start. I think smaller, regional meetings may have a positive impact on participation and potentially lower the cost burden. Also, travel for site staff may be minimized in the process.
What if we had technology to streamline passwords?
What if we had tech that allowed us to link passwords (for example, all eight of them in one study) to our fingerprint, much like we have on our cell phones? Or, what if one unique sign-in for a study was universal for all management of the study (EDC, supplies, IRT, etc.)? How might these lower the burden of password management that we all deal with daily? The volume of unique passwords seems to be increasing alongside the complexity of each study.
Case in point: Have you ever planned a randomization visit? You start by syncing the physician’s schedule with the family’s availability, choreographing each sample collection and questionnaire to fall within the minutes between other trial procedures, then, you have to make the pharmacy calls. The pharmacist or tech cannot find their password to access the IRT. The problem? It was assigned two months prior at the site initiation visit (SIV). They are asking if they can use the drug resupply password or the EDC password they use to sign-off the dispensing. No. Those are all different passwords for different websites with different trial functions. The clock is ticking, and you need to pick up the study drug and get it to the patient. Why isn’t there a better solution yet?
Turning Ifs Into Ideas
What if these “ifs” could result in IF (idea formation)? What if we gathered and drew a fishbone diagram and plotted out these “what if” scenarios? Then we could change the way we approach clinical trials. If we could all challenge the standard approach, we might make some real progress. What ideas do you have?
- Spaar A, Frey M, Turk A, Karrer W, Puhan MA. Recruitment barriers in a randomized controlled trial from the physicians' perspective: a postal survey. BMC Med Res Methodol. 2009 Mar 2;9:14. doi: 10.1186/1471-2288-9-14. PMID: 19254374; PMCID: PMC2653070.
- Lutz J, Pratap A, Lenze EJ, Bestha D, Lipschitz JM, Karantzoulis S, Vaidyanathan U, Robin J, Horan W, Brannan S, Mittoux A, Davis MC, Lakhan SE, Keefe R. Innovative Technologies in CNS Trials: Promises and Pitfalls for Recruitment, Retention, and Representativeness. Innov Clin Neurosci. 2023 Sep 1;20(7-9):40-46. PMID: 37817816; PMCID: PMC10561984.
- Akhter, M (May 04) Why meeting in person is more important than ever. https://envoy.com/blog/meeting-in-person/#:~:text=Virtual%20meetings%20shouldn't%20be,camaraderie%20and%20relationship
- Lake E (2008). Inside Investigator Meetings. Applied Clinical Trials. 2008 06-01-2008, Vol 0 Issue 0.
About The Author:
Teri Crumb is a clinical research nurse. She has coordinated clinical research trials for over 20 years and has experience in multiple pediatric clinical areas. She has been a speaker at local, regional, and national research conferences. She obtained her BSN from Grand Valley State University, her MSN from Drexel University in clinical trials research, and certification through the Association of Clinical Research Professionals (ACRP). Her areas of interest are the training and education of clinical research staff. In 2022, she started her own LLC as a clinical research consultant.
About The Author:
Teri Crumb is a clinical research nurse. She has coordinated clinical research trials for over 20 years and has experience in multiple pediatric clinical areas. She has been a speaker at local, regional, and national research conferences. She obtained her BSN from Grand Valley State University, her MSN from Drexel University in Clinical Trials Research, and certification through the Association of Clinical Research Professionals (ACRP). Her areas of interest are the training and education of clinical research staff. In 2022, she started her own LLC as a clinical research consultant. As a pediatric nurse, she loves all things Disney/Pixar including a couple of her favorite movies: “Finding Nemo” and “Encanto.”