Staffing shortages are a huge headache for managers in retail, foodservice, manufacturing, and scores of other industries. With clinical research, such shortages can significantly slow trials and prevent new therapies from getting to patients in a timely manner.
However, Melissa Easy (vice president of clinical technologies with IQVIA) believes advanced technologies might help bridge the gap and prevent the lack of sufficient staff from bringing research to a halt. She spoke with Outsourcing-Pharma about staff attrition and solutions that can alleviate such woes.
OSP: Could you please share an overview of trends in clinical research staffing?
ME: Clinical research staffing has always been challenging. Investigators, sub-investigators, study coordinators, and others at the research site are in essence doing two jobs at once – treating patients, which always takes priority, and running trials, which requires extensive amounts of clinical and administrative tasks. Taking on clinical research is not glamorous, and it is not a way to become wealthy. Medical professionals do it to make a difference in their patients’ lives, so it takes a special type of person to join and remain in the clinical trial industry for the long term.
In recent years, running trials has become even more difficult. That’s because the typical clinical trial protocol, which is essentially the guidebook developed by the pharmaceutical sponsor of the trial for the research site to follow, has become increasingly complex. As potential new therapies become more targeted to specific genomes or other biomarkers, trials involve more diagnostics and treatment arms. It is harder for sites to find appropriate patient participants.
Complex protocols require more training and are more difficult to integrate into operations at the clinic. We’ve seen an increase among our in our pharmaceutical customers asking us to staff nurses at their selected clinical research sites to provide the extra support for their trials.
Sponsors provide a wide range of technology for site staff to use, but often that leads to more confusion and administrative burden across the many trials a site may be running. The result is higher levels of burnout for clinical research staff.
OSP: COVID-19 has impacted staffing in many different fields. Please tell us how the pandemic has affected clinical study staffing in particular.
ME: The impact of COVID-19 on clinical study staffing continues to evolve, in directions that many did not predict. At the start of the pandemic, sites and studies were shut down until the industry was able to accelerate the adoption of telemedicine, home-health solutions, and remote capabilities. COVID-19 vaccine and treatments trials with tens of thousands of patients started up at “warp speed” with decentralized trial solutions that had only been dabbled with in small-scale pilots before the pandemic struck.
Soon the industry began to pledge that there would be no going back to the old way of doing trials, referring to the use of digital technologies over paper and to bringing more of the clinical trial into the patient’s home. Indeed, this won’t go away. But clinical research sites, as with most medical institutions providing direct care to patients, have been impacted more than other industries by the pandemic. For medical personnel, there was no “working from home” in the midst of a healthcare crisis. Stress and burnout, dependent care, vaccine mandates, long hours of continuous mask-wearing, and financial pressures have all contributed to the “great resignation” of clinical staff.
The Society for Clinical Research Sites recently released on Open Letter detailing the critical nature of attrition. Its April 2022 site survey indicates that:
- Site networks are averaging double the usual turnover rate of patient-facing staff from a range of 10% - 37% pre-crisis to current rates of 35% - 61%
- The direct costs of patient-facing staff have increased as much as 50% since pre-COVID times, due to salary increases, retention bonuses, and other compensation to compete with recruitment from pharmaceutical companies and CROs, which are also experiencing staff shortages
OSP: How can technology help companies deal with current staffing shortages, and maybe even help prevent future personnel issues?
ME: Technology that can help onboard new personnel more rapidly and remove the administrative burden of conducting trials is best positioned to help companies and sites deal with current staffing shortages. Too often the technologies that pharma companies give to sites exasperate site personnel. That’s what can happen when the technology is being implemented to help the pharma company be more efficient, not necessarily the site.
For example, IQVIA Investigator Site Portal (formerly known as DrugDev Spark) serves as a one-stop shop for sites to go to for everything they need to know about a study. So, if a person leaves and others need to pick up the responsibilities, they will find everything needed – all the training courses, study-related documents, safety notifications, news items, visit calculators, study contacts, quick links to related systems, and more – in one spot. Cross-trial efficiencies are very important to sites, so if a site staff has already completed a training course or acknowledged receipt of a safety letter for one study, the system recognizes that and gives them credit for a different study needing the same course or a safety letter sign-off for the same compound.
Another example of a tech product that can help with staff shortages and the financial situation at sites is IQVIA Clinical Trial Payments. Making payments to sites for the work they perform in clinical trials sounds like it should be easy, but it is actually quite complex due to regulations that ensure transparency in the financial transactions between sites and pharmaceutical sponsors. We have seen our client Bayer Healthcare measure a 90% reduction in administrative burden on their staff. They were able to pay sites twice as fast while reducing payment inquiries from sites by more than 75%, leading to an 80% increase in site satisfaction. All these improvements mean fewer headaches and better job satisfaction for everyone involved, which should translate into less attrition.
OSP: Can tools like AI help with recruiting as well as retention?
ME: Both patient recruitment and retention for clinical trials and talent acquisition have an impact on clinical study staffing. For instance, we are applying AI and machine learning (ML) to real-world data to build an effective site selection strategy earlier in study planning. This strategy workbench application is able to tier sites and rank countries with expected enrollment rates to predict the best combination of sites per country and countries per study, which means that sponsors will invite sites that have access to the right patient populations and are best positioned for success with a particular protocol. This of course makes patient recruitment easier for them, reducing frustration and staff turnover, we suspect.
In addition, we continue to advance technology that helps reduces mundane tasks and allows staff to be more productive and focused on patient care. For instance, IQVIA has developed an AI application that is helping to reduce administrative tasks related to a regulatory requirement known as the Trial Master File by 75%. The benefit to site staff is that they aren’t bombarded at the end of a study with requests for documents that are missing from the Trial Master File, which can be a huge frustration and distraction for them.
You can see that the theme is to take away these negatives of running clinical trials and make the jobs of clinical study staff more rewarding.
OSP: How can companies like IQVIA help study professionals keep staffing challenges from being a serious problem?
ME: I don’t think any company has such a keen focus on the challenges of the clinical research site as IQVIA. When I founded DrugDev, we were completely focused on helping pharmaceutical sponsors do more trials; but we were unique in that we were approaching all our software development from the perspective of the site – giving pharmaceutical companies the tools needed to in turn make the site’s life easier. And that is the same reason IQVIA acquired DrugDev. As IQVIA was delivering clinical development services, they saw the huge need to help study professionals do their jobs more efficiently and reduce the heavy administrative burden placed on them – from our own clinical research associates working directly with sites and from the site staff themselves.
Going back to what I said earlier, the site’s first job is treating patients and so we absolutely have to make their second job as easy as possible, or they will give it up. IQVIA recognizes that, and we are all laser-focused on helping study professionals be successful by drilling down on every inefficiency and every opportunity to make trials easier. We are doing a lot of work in study planning with our clients, providing data products, and applying AI/ML technology for the early design of studies, such that pharma companies can get early input from sites on the patient population and protocol design and even look several years in advance at whether multiple studies can be collocated. For feasibility and site selection, we have new software that reuses the information collected from sites, so they truly don’t have to keep answering the same questions over and over.
I’m very proud to say that our new Feasibility product is measuring site satisfaction within the tool itself and most recently found that 95% of sites that responded to our feasibility surveys for site selection would recommend the solution to a colleague. Those are the numbers we strive for in our technology, and that is what we need as an industry to achieve if we want to reverse the current situation and keep site staffing challenges from being a serious problem.
OSP: Is there anything you’d like to add?
ME: IQVIA is very broad in the solutions it provides to the pharmaceutical industry, and many don’t realize that we are much more than a CRO. IQVIA Technologies is essentially a large software development organization for both clinical and commercial products. I specifically work with 25 clinical technology products that we license directly to our customers. But IQVIA also “eats its own cooking,” as they say. That CRO side of IQVIA uses just about all of our software products in the delivery of clinical services.
It is an unmatched feedback loop within an organization to have so many trials in every therapeutic area and every model being run on your software, and that’s why our products are best-of-breed and keep getting better. In turn, that’s why our CRO keeps getting stronger. It’s an exciting place to be, and we stand ready to solve the site staff attrition crisis. The future of clinical trials and the health of patients are at stake.