Hybrid trials benefit sponsors and CROs by offering increased participant enrollment and retention opportunities. Ultimately, however, the most prominent impact of these patient-centric designs is on the participants. Giving participants the option to complete a portion of their clinical visits at home or in their local communities rather than commuting long distances to clinical sites encourages them to participate in innovative research. But what are they like for participants?
Experts Lisa Kodis, Clinical Research Lead, and Kimberly Woodson, Clinical Portfolio Manager for Medical Research Network (MRN), explain the participant experience in Keeping Clinical Trials on Schedule: the Role for Decentralization in Condensing Timelines.
How Can Clinical Trials Mirror A Consumer Model?
Modern society has grown used to conducting business from the comfort of their homes, from work to grocery shopping to managing their finances, and they expect quick turnaround times. Pharmaceutical companies benefit from viewing study participants as valuable consumers and finding ways to make participation more accessible and convenient. Patient-centric trials offer tailored support that fits trials into people’s lives while providing invaluable human contact through HCP visits.
When planning remote or in-home visits, solution providers like MRN first review the scope of work with the sponsor to see what can safely be done in a participant’s home. The patient population is a key consideration when selecting and training HCPs. For example, if the participants are children, only HCPs with experience treating children would be chosen for the trial.
A solution provider should offer research experts to advise sponsors on the best way to incorporate home visits into their studies. MRN has assisted with clinical trials for over 100 indications in more than 60 countries, offering expertise across many therapeutic areas. In addition to the clinical team, MRN has a project management team, clinical services team, and regulatory review experts to cover every aspect of the scope of work. This holistic approach allows MRN to determine the best way to offer at-home care to study participants.
By bringing a trial to a patient in their home, school, place of work, or other designated location enhanced by digital technology in the home, this model gives patients a choice of when and where they want to participate, creating the convenience a consumer would expect.
How Does a Hybrid Trial Model Affect Participation?
Participation in a clinical trial begins with the consent process, in which the participant becomes fully aware of what the trial entails, its goals, and risks vs. benefits. When the trial uses a patient-centric model, a patient is presented with the option to participate in a location more convenient to them for a portion of the visits.
Although the participant will have to visit the site for key appointments, the goal is to reduce as many on-site visits as possible. This flexibility leads to accelerated timelines for trials. When a patient has the choice to have a more convenient trial, recruitment and enrollment increase, and retention is improved as dropout rates are reduced. When sites enroll more patients and fewer drop out of the trial, the drug development process can speed up.
MRN works with sponsors and sites to create the most integrated, patient-centric approach to all hybrid trial elements. An important part of this process is onboarding highly skilled and trained HCPs to deliver care in the home. In addition, supporting, resourcing, and training sites are critical to the success and impact of these models. Lastly, integrating the technology needs to be carefully considered to collect on-site and in-home data seamlessly.
Companies looking to recruit participants for their clinical trials should begin by viewing the study’s requirements from a patient perspective. When convenience and compassionate care are factored into the equation, the entire study benefits.