Do Community Based Trials Actually Improve Patient Access?
I only have MRN data to go on – so this is all based on MRN internal analytics. There are some external references listed at the end for context.
We are regularly told sites using our services achieve 50% increased recruitment or more. Here’s is what we believe drives these results.
Those working in the industry know that most patients in clinical trials are still white and male and that the proportion of all types of minorities in trials is not representative of their share of the population. The FDA and other agencies are encouraging Sponsors to ensure recruitment into trials more closely reflects the make-up of the populations they represent.
This is not easy to achieve. However, when a Sponsor decides to meet this challenge, the result will trend towards an increase in complexity, making the challenge one of achieving the inclusivity sought without slowing recruitment or increasing cost. There are logically two types of solution to the challenge – those that control diversity of patients recruited into the study to ensure the correct mix, and those that enable access to all the populations that should be included.
MRN’s community based trial methodology provides strength and expertise is in the latter category – enabling access. This also has two main logical themes – making the trial manageable for sites that have the desired patient access, and making the trial attractive to the patientsyou are looking for.
Theme 1. Making the trial manageable for sites with the desired patient make up – ie improving patient access through site selection
Sites focused on – and able to effectively access – the desired populations will often be new to research (trial naïve), otherwise we would not have this problem today. They will have to be trusted by the communities they serve. They will often be in areas of high density of lower income families and may often have poorer facilities. However, the physicians and surgeons who work there, and their staff, are just as likely as any other to want to take part in trials. MRN’s site network is designed to be inclusive of trial naïve sites and to provide transparency to site demographics and minority representation in their patient population. MRN also provide access for all sites in the network to training and all the support and resources the site needs in order to participate in research, as well as ensuring the sites that are comfortable with using Home Trial Support nursing and other community based trial services. This should ensure clients accessing the network, can target sites effectively to reach their target populations and be assured that all sites, no matter how inexperienced, have the support and resources they will need.
Theme 2. Making the trial attractive to the patients you are looking for – ie improving patient access by making the trial easier to participate in for them.
Patients need to be supported to participate. Present patient populations tend to have too high a preponderance of white, middle income (plus) males. It is therefore logical that addressing the difficulties in accessing trials for women and lower income patients would be a positive step.
In the spectrum of options available to achieve this, two are ‘stand out’ for me. First is to give the patients the freedom to be seen in a convenient location – most likely their home – and second is to give patients the freedom of being seen at the time of day or day of the week that suits their lives. These will reduce cost to patients, reduce the need for transport, reduce the need to be accompanied by a carer, allow people to be seen outside working hours (whatever those might be), or whilst at work or at school.
Being seen in these settings also means you can extend the geographical reach of recruitment for a site. In a sample of 5,000 adults, the travel distance they were willing to take for future routine care visits was 20.4 miles for all adults. For those age 65+, it was reduced to 18.1 miles, Hispanic origin reduced further to 17.9 miles, and for urban residents 17.6 miles (Data Source).
An analysis of 318 patients MRN has supported in their clinical trial journey showed the median distance from them to their clinical trial site was 64 miles.
For these 318 patients, MRN’s Home Trial Support Healthcare Professionals were able to deliver clinical care to patients an average of 178 miles from the site, significantly expanding the reach of the site. (Data Source: MRN Analytics).
MRN has averaged over the course of our operation, from between 12% and 30% of our clinical visits taking place outside of standard clinic hours. Given there are very few studies that specify a particular day of the week for a home visit, we estimate a further 50% or more of our patients may be seen on a different day of the week to the day offered by the site clinic.
Bringing the themes together, across these two main pillars of solutions for community based trials, Sponsors are able to pick sites strategically to ensure the most diverse patient access is achieved and are able to offer the patient freedom to be seen where and when is most convenient for them, all the while making participation easier. This dramatically increases the size of the patient population who can access the trial, and allows access for those with greater constraints on their participation – such as being unable to give up work time, supporting a family, caring for children or the elderly, attending education etc.
Of course, there is more to inclusion than opportunity for access. Other services are critical, such as inclusive communication medium, appropriate and varied language for consenting and engagement techniques, staff form representative cultures, etc. The more of these that are undertaken the greater the synergy and the faster the trial runs.
Sources:
1 – Gallagher, A. 88.9% of US Population Lives Within 5 Miles of a Community Pharmacy (2022) https://www.pharmacytimes.com/view/study-88-9-of-us-population-lives-within-5-miles-of-a-community-pharmacy
2 – MRN. Decentralization, The evolution of clinical trial design (2019) https://resources.industrydive.com/decentralization-the-evolution-of-clinical-trial-design?utm_source=BP&utm_medium=Library&utm_campaign=MRN
3 – Stepanikova I, Oates GR. Perceived discrimination and privilege in health care: the role of socioeconomic status and race. Am J Prev Med. 2017;52(1S1):S86–94.
https://www.sciencedirect.com/science/article/abs/pii/S0749379716304664
4 – Howard, J. Only 5.7% of US doctors are Black, and experts warn the shortage harms public health (2023) – https://edition.cnn.com/2023/02/21/health/black-doctors-shortage-us/index.html
5 – MRN internal analytics
I write on anything I think is patient centric and interesting, based on my 18 years leading MRN, the oldest patient centric company in the world…(probably).
For more info on how to manage community based trials, go to the MRN web site
Author: Graham Wylie, Executive Chairman, MRN