TargetCancer Foundation implemented Medrio’s remote consent function in their TCF-001 TRACK study, which has an objective to determine if rare tumors can benefit from matched molecular therapy. The study is remotely enrolling a total of 400 patients in the United States using electronic informed consent. Medrio’s eClinical solution provides significant benefits to TargetCancer Foundation including reduction of unnecessary delays, improved access to dispersed patients, privacy of review within the patient’s home environment, and increased patient and caregiver understanding.
TargetCancer Foundation, a patient-founded not-for-profit organization, sponsored the TCF-001 TRACK (Target Rare Cancer Knowledge) study to establish whether patients with rare tumors can benefit from matched molecular therapy. This is an open label, non-randomized, multi-center, pragmatic study that utilizes next-generation sequencing (NGS) results. The study is active and enrolling 400 rare cancer patients across the United States without a centralized physical site. One of TargetCancer’s aims is to provide patients and their treatment care teams with genomic information and individualized treatment recommendations without requiring them to travel to a medical center.
The interventions for these patients include genomic sequencing, Virtual Tumor Review Boards, and personalized recommendations about on and off-label treatments, and clinical trials where appropriate. The genomic data generated from this study helps drive a better understanding of often overlooked rare cancers and can prove to be invaluable to researchers in the future.
When dealing with such a disparate patient population, flexibility is the key to reaching, consenting, and tracking your patients’ ongoing comprehension. As with other rare diseases, many of these patients cannot travel to a site regularly or do not live in proximity to an academic medical center. Remote access and communication tools become critical to the success of these trials and the relationship between patients and their treating physicians.
As Jim Palma, Executive Director at TargetCancer Foundation notes, “Our goals with the prospective study is to address the challenges that exist in rare cancer research and especially in the rare cancer patient experience.”
By providing the informed consent details electronically, patients were able to overcome traditional geographic and physical barriers that hinder their participation. Instead of having to navigate paper or in-clinic consent workflows, patients and their caregivers were able to access consent information easily and safely and from the comfort of their home or personal device. They could review and digest the information at their leisure, allowing them time to better comprehend and understand the consent form content.
“We found that patients and caregivers were more willing to ask questions about the consent process when given the flexibility to read over the information on their own, without time constraints,” explaines Jim.
The participant pool spans across a wide range of ages and technical abilities. Palma noted that patient reception to remote consent has been positive across all cohorts and the lack of user issues spoke to the natural intuitiveness of Medrio’s remote consent tool.
TargetCancer Foundation found Medrio’s remote consent set-up to be fairly intuitive and straightforward. They benefited from additional support through Medrio’s responsive customer support team.
“When we were evaluating tools, our team liked how user-friendly and collaborative Medrio’s interface was. The tool allowed for same day changes that we could implement in real-time without impacting our study,” shares Palma.
He also notes, “Managing the consent tool was easy and collaborative, but whenever we needed support, the Medrio team was quick to respond.” Like when the TargetCancer team needed support setting up their initial consent forms. “Regardless of the time of day, Medrio’s team would get back to us quickly and prioritize a real-time response that helped us maintain our study timelines.”
TargetCancer needed a tool that addressed known industry challenges. “We’ve worked closely alongside patients and knew we needed a user-friendly informed consent tool that gave them the ability to initiate the consent process themselves. We chose Medrio because their flexible solution allows us to configure consent how we need it, make changes quickly, and, most importantly, retain control over our data,” details Palma.
Medrio’s remote consent also allows study managers to view the real-time delivery and receipt of consent forms, eliminating mail delivery delays, and enabling a follow-up process to keep the study on track. Palma explains, “What we like most about this is that there are no questions as to whether or not the patient has received the forms. We can see in real-time if the forms have been received and viewed so we know to follow-up to see if there are any questions.”
Through the use of Medrio’s remote informed consent tool, TargetCancer is improving their overall participant experience while providing patients and their care teams with data to help them make informed treatment decisions.
TargetCancer Foundation is a patient-founded nonprofit organization dedicated to supporting rare cancer patients and researchers, based in Cambridge, MA. Since 2009, TargetCancer Foundation has fostered the development of comprehensive rare cancer research programs through long-term commitments to basic research funding, the development of research tools such as cell lines, and innovative scientific meetings. In addition, TargetCancer Foundation serves patients facing the unique challenges of rare cancers through direct guidance and clinical trial navigation, as well as the development of impactful patient-focused research studies. For more information, please visit targetcancerfoundation.org.
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