Finding The Solution(s) That Meet The Needs Of Patients, Sites, And Sponsors

To find the solution to any problem, it is critical to understand the issue that is trying to be solved. And when we say understand – we mean having a deep and thorough grasp of what that problem is.

On the surface, it’s really quite simple – patients are not enrolling in clinical trials, and those that do are not staying in the trial. So, the next step is to ask why – and this is where things get interesting, because there is no one answer that can be applied to all clinical trials. Rather, there are several, in varying combinations that patients experience when it comes to deciding to either enroll or remain in a trial.

Why Are Patients Not Enrolling Or Remaining In My Trial?

Here is where we truly need to understand the clinical trial design and what should be done differently to improve enrollment and retention right at the start, so that the problem(s) is not repeated.

1. How easy is it for patients to enroll and from where? There are a lot of variables to answer this question, one largely involves site selection – are you bringing onboard sites that can be productive for the trial? What are your enrollment goals and is the site accessible to these patients? Is this site equipped with the staff and facilities to effectively run the trial. How many other similar trials are being run at the site that will compete for the same patient population?

Often the same sites are selected – which are often traditional academic sites The idea is that the attached hospital will supply the patients. The problem is, they’re likely to have patients that, while being local to the area, are exactly that – local to the area and unlikely to be representative of a diverse population.

These sites will also have competing trials, cannibalizing the potential recruitment pool of an already geographically restricted group, all run and delivered by a depleting pool of qualified research staff. We aren’t painting a very pretty picture, are we?

2. Frequency and burden of trial visits. How many visits are patients expected to attend? What is the length of those visits? Will patients be able to get themselves home afterwards or will they need assistance? Does this visit actually need to be done at the site or could another Healthcare Professional (HCP) conduct the visit?

Patients enrolling in trials are enrolling to a schedule of assessments, often requiring frequent visits to the site which can become inconvenient, quickly.

When it comes to how much time you’re taking from someone, ill or otherwise, that time is still precious. Time is the one thing that cannot be given back and is a key factor in a patient’s decision as whether they should participate or remain in a trial – especially as it is not always their time, but that of family members – either in a caregiver role or simply someone they want to be able to see and spend time with during a difficult time.

However, this is one is a little more obvious when it comes to a solution – it’s something CEOs and top flying executives across industries have already solved for us. They save time by bringing their work to them, not the other way around. Wherever they are in the world, they are able to conduct the majority of their business – returning to the office for major business deals etc.

For patients, the answer is the same – bring the trial to them, wherever they are in the world and limit site visits to only those that must be conducted by a member of the study team or assessments /treatment that cannot or should not be done outside of the research site.

What Are The Patient Enrollment & Retention Solutions That Can Help Move The Needle?

It really depends on what your trial needs – or rather, what it may be lacking for sites and for patients. There are many solutions that can work independently or together:

Site Networks: These are becoming increasingly popular. However, not all site networks are the same. There are those that have a collective group of traditional sites and continue to operate the same way traditional sites do, and then there are those that have a mix of site types. And it’s that diversity in site types, that gives us diversity in patient populations.

What is a “site type”? A type of site means – traditional sites (they do still have a place), trial-naïve sites (which have limited experience running trials), community sites (smaller sites that are located in the heart of communities) and even pop-up or mobile sites.

By having access to a variety of sites, in a multitude of locations , it is possible to reach a diverse mix of patients right in their communities. Further, the right site network will support its sites. Providing training to trial naïve sites, as well as tech to run the trial, logistical support, a dedicated management team, staffing and more.

This is exactly what MRN’s Site Network is championing by taking site networks to the next level. We don’t just provide access to sites but rather access to supported sites that are empowered to meet deadlines and objectives, while providing healthcare access to the site’s local communities.

Site Support: Where sites may have already been chosen, or there are more restrictions on locations, a solution that provides sites with additional support may be the answer.

And this can come in many forms. It may be that a site needs administrative or project management support, or access to more streamlined data collection platforms. Or they may just need more HCPs to see more patients.

Site Support solutions can help any site type – it’s just about understanding their needs and finding the most effective way to meet them. Further, supported sites usually mean better supported patients as waiting times at visits are shortened and more one-to-one care can be provided.

Solution providers offering site support need to have a nuanced understanding of how clinical research sites operate in order to identify what support is needed to be effective, as opposed to throwing everything at it and subsequently throwing money down the drain. Sometimes just one or two tools or additional sets of hands can make all the difference.

And even experienced sites can benefit from support. MRN’s Site and Patient Support Solution demonstrated this in a rheumatoid arthritis trial where it supported trial naïve sites with enrollment and retention – achieving 20% higher enrollment rates than experienced sites recruiting for the same trial.

Both these solutions can answer most of the questions asked, except for one – how to bring the trial directly to the patient, reducing their participation burden to improve retention rates, enter Home Trial Support.

This solution has a lot going for it as, just like site networks, it helps both patients and sites get what they need – even when being used as a standalone solution.

Home Trial Support (HTS): The HTS solution is often misconstrued as a solution that is needed for patients that struggle with mobility, however it offers so much more. Yes, it certainly is a solution for patients who struggle to participate because of physical struggles, but it is also a solution for patients who are out and about just living their lives.

Patients who are going to work or school or playing with their grandchildren – these patients are often trying to keep a sense of “normality” going as they fight their disease. When they are suddenly spending their time travelling to and from, as well as time at trial sites, it becomes so, so much harder to do that.

However, that is eliminated through an HCP coming to them wherever they are – home, work, school, or other approved location. This saves precious time and allows them to lead as much of a “normal” as possible.

HTS also supports sites – having a non-site study team member take on those visits that don’t actually require the patient to be at the site, means that time is not just returned to the patient but also the site team. There is one less visit and the subsequent paperwork that needs to be done by them – allowing site staff to more effectively see those patients that do need to be at site for treatment.

And it’s not just time and convenience that HTS provides sites and patients and their caregivers, a truly effective HTS solution offered by highly experienced providers, such as MRN, offer a myriad of hidden healthcare benefits.

Conclusion – What You Should Expect From Your Vendors

When it comes to finding the right solution(s) for your trial, it is imperative to engage in conversations early in the trial design process.

Vendors should have a consultative approach, designing and delivering what is best for the patient, site, and ultimately trial objectives.

Make sure that you are asking them the same hard questions about site productivity, the safety of their protocols in place for delivering remote trial visits to patients. They should provide you with in-depth information and even additional ways in which the solution(s) can be tailored to meet your trial’s specifics needs.

There is never a one-size fits all when it comes to trials or patients – learn more about how MRN’s solutions are specifically designed to work together or independently to ensure the right fit right here.