By Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare

Clinical trials are an essential component of patient care in a number of diseases, but I would argue that nowhere are they more important than in life-threatening diseases like cancer. Today’s clinical trials are tomorrow’s standard of care and as such it is important that cancer centers have the resources they need to test new therapies in a safe and expedient manner. However a recent National Cancer Institute (NCI) survey of 64 NCI-designated Cancer Centers presented at the American Association of Cancer Institutes (AACI) meeting in June revealed a significant challenge to this mission in that fifty percent of respondents said that they do not have the staff necessary to conduct the same number of trials they did before COVID. 

Specifically, the data showed that the majority of Cancer Centers felt that limited research staff capacity was having a major impact on trial openings and forcing accrual holds. Meaning that studies are opening slower and physicians are being asked to stagger trial referrals so that the staff can keep pace with the demand and still maintain patient safety. Slower study starts mean longer approval timelines and less access to important therapies for patients. David Hong, MD, of The University of Texas MD Anderson Cancer Center in Houston, has stated that despite efforts to accelerate testing and regulatory decisions, “[the U.S.] still take[s] about 7.6 years to get a drug approved.” That’s a long time when you are a patient living with cancer. 

As anyone who has ever worked on cancer studies knows, cancer trials are inherently complex and time consuming. They require close patient monitoring, specialized equipment, and rigorous data collection. Studies of this nature take time and resources, something the majority of cancer centers are sorely lacking in today’s economy. As a recent article on the staffing crisis in clinical trials points out, there is a “glaring disconnect [that] is evident between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits.” Thus the question in front of a number of cancer center leaders is how can they augment their staff without compromising the integrity of patient care? The answer is a shift towards hybrid trial design and site-owned technologies like tele-health, eConsent, and remote data capture.  

Amidst these technologies, eConsent emerges as a practical and approachable starting point for integrating digital technologies into clinical trials. The implementation of eConsent can simplify workflows, improve patient engagement, reduce deviations and save valuable staff and patient time. By starting with eConsent, cancer centers can ease into the digital transformation, building confidence and competence to gradually incorporate more complex tools like remote monitoring and telehealth. This gradual approach can pave the way for a successful transition to modernization and increased capacity at the trial site. Meaning more opportunities for study staff to engage with patients and more room for starting new studies.

eConsent can offer more flexibility for participants and reduce admin burden on study staff. The application of eConsent in clinical trials, despite the potential intimidation factor of new technologies, is generally well-accepted by patients and the FDA. Marc Theoret, MD, deputy director of the Oncology Center of Excellence at the FDA, has noted that allowing patients to provide informed consent electronically is one of several strategies that could help draw in patients who have busy schedules or cannot travel to trial sites. eConsent can also simplify a complex process, fostering improved patient comprehension and engagement. 

Sites sometimes assume that patients coping with serious illness would prefer to do fully site-based trials. However seriously ill participants can benefit from the convenience of remote/electronic consenting as studies have repeatedly demonstrated the impact of financial toxicity and time commitments on a patient’s willingness to participate in oncology trials.Cancer patients already endure so many doctors’ appointments as part of their standard care that the idea of adding even more visits could deter them from participating in a trial. With eConsent patients could sign consent forms from home or in the office based on their personal preference. For those patients who chose to come in for a consent conversation, they can come in having fully read the information and prepared to have a more focused discussion with the study staff on what their participation will entail. 

The benefits of eConsent extend beyond patients to clinical trials, leading to improved compliance, higher patient enrollment, increased geographic reach of studies, and standardized documentation processes. These advantages subsequently save time and resources, reduce the risk of misinformation, and minimize the need for on-site monitoring​​. All of which open up study staff to do higher-level work, like engaging with patients. 

Further, consent deviations remain one of the most frequent protocol deviations reported to the IRB, with approximately 20% of all protocol deviations involving a failure to obtain proper informed consent. With 34% of those consent deviations being tied to patients receiving the wrong version of the consent form. Platforms like eConsent create tighter version controls and standardize workflows to minimize human error. As cancer centers today are fighting for staff and patients, they cannot afford to lose data or resources to protocol deviations. Investing in an eConsent platform yields a substantial advantage: control. This isn’t simply about acquiring a tool—it’s about gaining the power to optimize clinical trial operations with precision.

Sites who own their own eConsent platform have full authority over their workflows, enabling  customization and enhancing productivity while minimizing errors. These centers also control the content, ensuring it aligns with their trial’s objectives and patient needs, providing a more patient-centric experience. Moreover, eConsent is one of the easiest systems for overworked cancer centers to implement as it is a discrete process with beginning and end. It can be integrated into other systems or left as a stand alone based on site preference. Additionally, eConsent allows for its integration across the entire trial portfolio, eliminating study by study workflow changes that slow staff down and create opportunities for error. By owning their own technology, cancer centers can create a standardized approach that simplifies operations and provides a consistent patient experience across all their trials.

In conclusion, eConsent acts as a valuable springboard for cancer centers to embrace the future clinical trials. It simplifies processes, enhances patient engagement, and addresses key operational challenges.

As you chart your path in the digital transformation of clinical trials, we encourage you to discover Florence’s eConsent solution. Designed to streamline operations and improve patient experiences, we are here to support your transition to this new paradigm in clinical trials.

To further understand how Florence’s eConsent solution can assist your clinical trials, [click here]. We are committed to helping you make that first step towards enhanced, patient-centric clinical trials with confidence. Your journey to a more efficient and effective clinical trial system starts with eConsent, and we are here to guide you.

About the Author

Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. She currently serves as the Chief Clinical Trial Officer for Florence Healthcare, a software company focused on connecting sponsors and sites worldwide. Catherine is a subject matter expert and key opinion leader on patient-centric, decentralized and hybrid trial design. She has worked in multiple therapeutic areas in both academic and community hospitals, with her most recent appointment being Director of Clinical Research Administration for the Vanderbilt-Ingram Cancer Center. Additionally Catherine serves in leadership roles in numerous industry associations  including Chair of the Site Enablement League, board member for the Association of Clinical Research Organizations (ACRO), member of Association of Clinical Research Professionals (ACRP) Workforce Innovation Board, Clinical Trials Transformation Initiative (CTTI) and others. She is passionate about changing the clinical trials industry and empowering women as leaders.