Author: MRN
This is an exciting time to be involved in clinical trials. The tide has shifted to a patient-centric focus with rapid changes in how clinical trial visits are conducted. More and more clinical trial visits can easily be conducted outside the site, in the patient’s home to ease the patient and family-caregiver burden.
Several years ago, our MRN healthcare professional team had the pleasure of caring for a young father named Sam, who courageously joined one of the first clinical trials testing a new drug that would later become an approved blockbuster and standard of care cancer drug. This combination drug treatment gave him side effects lasting a few days that made everyday tasks, even getting out of bed, a challenge.
A trip to the site was a four-hour round trip for Sam, meaning he’d also need to stay overnight, away from his wife, young son and 2 dogs. Fortunately, MRN was able to treat him at home, giving him more of those special cherished moments with his family, surrounded by his greatest support system during the hard days when the side effects were at their worst. Home Trial Support (HTS) gave Sam back a piece of control of his life and gave him precious time that would have been lost with constant trips away to site. Thanks to the patient-centric movement in clinical trials, we have countless stories like Sam’s where we’ve been able to give patients relief from demanding trial schedules and more time at home, in comfort, healing.
The patient-centric focus in clinical trials has given more patients living greater distances from a research site the opportunity to enroll and participate in clinical trials. With the use of Home Trial Support visits paired with telehealth visits and wearable devices, the distance a patient lives from the site is a barrier that has been greatly reduced and has shown positive impact on enrollment and retention rates. Many patients with very rare diseases or challenging physical/mental disabilities now have easier access to much-needed medications and devices while helping to support research in their diagnosed disease.
Of course, the progress we as an industry have made has also introduced challenges. Challenges specific to in-home trial delivery includes; medical professional local licensing requirements, the scope of practice (country, USA state), logistics of equipment, patients in remote locations, IMP handling requirements, data collection, use of wearables and transfer of data to note a few. Additional challenges with the use of technology include; adoption of new and developing technologies and devices – like e-source and wearable and external devices, collecting digital data directly to the e-CRF while ensuring software security, and more.
MRN has recognized these challenges and has established dedicated teams that proactively and successfully plan for and manage those encountered with each protocol/trial HTS visit. Each visit is planned with the participant and caregiver needs as the focus from in-home trial delivery to site support to the technology we use.
For nearly 20 years, MRN has been at the forefront of this progress and continues to drive the momentum. With our solutions we provide expanded reach to diverse patients, offer in-home trial activity conducted only by highly skilled and qualified medical professionals, and access to new sites and communities through our global site network.
Actively scanning the horizon and implementing new and better ways to improve participation for the site and participant is key to continued success. Find and partnering, sharing knowledge and best practices with like-minded companies will help shape the future of patient-centric protocol design.
Learn more about MRN’s solutions here: https://themrn.io/solutions/