An excerpt from a white paper developed by MRN
The Covid19 pandemic has clearly highlighted challenges of “traditional”, site-centric clinical trial designs. More than ever, people are talking about direct to patient, decentralized or community-based clinical trials, buzzwords that have appeared in our vocabularies only just recently, but as the organization that pioneered these kinds of studies, over 15 years ago, we know that it isn’t an easy process. This isn’t about taking the complex and making it simple, it’s about making the complex happen efficiently and safely for patients.
Ensuring patients are safe, cared for and comfortable during treatment isn’t simple; making sure data is collected on schedule and accurately, so that the study either proves the efficacy of a treatment or disproves it quickly isn’t simple; coordinating medical professionals, patients, investigational medicinal product to a single point in time and location isn’t simple; managing sample collection, on site processing and shipping to central laboratories from multiple, domestic, locations isn’t simple. Pulling this all together across multiple patients, locations and visits is very complex. Our operational teams bring together the best in the industry to coordinate each and every study touchpoint and ensure your clinical trial can be run in the patient’s communities in an efficient and safe manner; but it isn’t simple.
What do you need to consider? Here are some of the points you should consider if looking to run community-based clinical trials:
What does the protocol entail?
What can be done within the protocol in a home/ work/school environment? Which visits should happen outside of the site? Is the protocol very visit intensive –frequent visits or intensive assessments? What patient centric recommendations can be made to best fit the recruitment, enrollment and retention for the study?
Who are your patients?
Consider your target population; where are they, who are they, what is the prevalence of the disease and how close are those patients likely to be to the sites? “Currently, 70% of potential clinical trial patients live more than two hours from a study center…” (Parexel, 2019)
If regular, in-person interaction between the patient and their physician is required, then visits to the site make sense for a patient relatively close to site. If those patients aren’t near to a site, they are going to struggle to meet the visit demands of the protocol and they’ll either not enroll or not be retained for the full duration of the trial.
Developing the protocol with the patient in mind is absolutely key. Speak to patient advocacy groups for the disease state, they know what it’s like from the patient perspective to take part in a clinical trial, they know how onerous it can be and understand the difficulties of the disease state that they’re trying to manage.
Family often have to take the patients to their visits so that should also be considered. Location is key to reduce the burden on the patient and their caregivers or families. Patients shouldn’t be expected to travel hundreds of miles to see a physician for every trial visit if some can be done at home.
If you are looking at using technology to facilitate virtual visits you must consider the age of the patient population. Will they know how to use a heart rate monitor or a tablet?
To be applying technology to a protocol you need to consider the infrastructure of the countries that you will be working in; how good is the WIFI, the broadband? Will 5G be supported? Do the patients have a WIFI network that can be used?
Who or what do you need?
A lot of detail is required around the actual scope of what needs to be delivered. Nurses conducting visits have a higher success rate if trained properly. What training and equipment is required for the research activities required? What experience do the nursing professionals require to deliver the research assessments? How do you ensure all research nurses are vetted appropriately? What training materials and support must be created to ensure all activities can be undertaken correctly?
Are there country-specific regulations that need to be considered?
There may be country-specific regulations that may complicate the running of clinical trials in the community. For instance, in some countries, we know the administration of certain drug types is forbidden outside of a clinic or hospital environment, or it may require a physician rather than a nurse to perform either the assessments or the administration. It’s not just the clinical research regulations that you need to familiarize yourself with, you need to broaden your understanding of the healthcare landscape in all countries that are being used for the study.
As well as regulatory differences from country to country, there are also cultural differences to consider as well. In some countries, it isn’t polite for patients to invite professionals other than their physician into their home and that would extend to nurses.
Many people will hear the word “decentralized” and think of technology, such as telemedicine or wearables, but it’s so much more than that. Performing a clinical visit outside of a site requires a trained healthcare professional, a delegate of the PI, to care for the patient and understand clinical research and the protocol. We know from experience that utilizing decentralized solutions isn’t a one size fits all solution. . The right solution should be determined by what is right for the patient. When you use the right tools, decentralized trials can be successful for all stakeholders.
