Challenges & changes in the patient centric movement by Joyce Smith
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, family-caregiver and site burden.
As a nurse with over 30 years of experience, I’ve had the opportunity to work with many patients, sharing in their emotional and life-changing medical journeys. These unique stories and memories drive the passion that I bring to work each day. I feel fortunate to have seen first-hand the impact of home support for patients in clinical trials.
Several years ago, I had the pleasure of caring for a young father, 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 dogs. Fortunately, I was able to treat him at home, meaning more of those special cherished moments with his family, but also meaning that he was surrounded by his greatest support system during the hard days when the side effects were at their worst. Home Trial Support 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’ve got countless stories like Sam’s where we’ve been able to give patients one more day, month or a lifetime of treasured moments with the ones they love.
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, telehealth visits and wearable devices, distance from the patient’s home to the site has greatly reduced this barrier to enrollment and positively increased retention rates. Many patients with very rare diseases or challenging physical/mental disabilities can now have access to much-needed medications and devices while helping to support research in their diagnosed disease.
MRN has been at the forefront of this progress and continues to drive the momentum. Currently, we are meeting the needs of patients, Pharma companies and CRO’s by providing expanding pools of diverse medical professionals to complete an ever-expanding list of unique and varied trial assessments at each home visit.
With great progress comes the challenges each trial encounters. These can include; 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.
The industry is facing addtional challenges; adaption to 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. We are embracing the technological escalation by planning and implementing strategies to prepare our teams to bring these seamlessly to our patients and customers.
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 subject and caregiver needs as the focus.
Actively scanning the horizon and implementing new and better ways to improve participation for the site and subject is key to continued success. Find and partnering, sharing knowledge and best practices with like-minded companies will help bring these to patients quicker.