Depending on their condition, patient participants are likely to find traveling to clinical research sites anywhere from mildly inconvenient to nearly impossible. Throw the COVID-19 pandemic and associated travel restrictions in the mix, and the challenge becomes even more daunting.
Sites and sponsors are finding mobile nursing and other home-based solutions can help alleviate some of the burden and trepidation. Illingworth Research Group provides clinical services to pharma, healthcare and other industries, including mobile research nursing, patient concierge and more; growing interest in home-based patient care in clinical research and other fields has helped the company grow since its founding 21 years ago to expand its services to 45 countries around the world.
Outsourcing-Pharma (OSP) recently spoke with Illingworth chief operating officer Jules Moritz (JM) about the evolution in mobile research nursing, home-based clinical research visits and the role in-home visits can play in the COVID-19 era.
OSP: Could you please share the ‘elevator presentation’ of Illingworth — who you are, what you do, key capabilities and services, and what sets you apart from the competition?
JM: Illingworth Research Group provides a range of patient-focused clinical services to the pharmaceutical, healthcare, biotechnology, and medical device industries. These include mobile research nursing, patient concierge, and medical imaging services.
Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas. We have grown organically over our 21-year history, and now offer our services in over 45 countries globally. We are dedicated to improving the patient’s experience in the clinical trial process.
OSP: How have home healthcare and mobile nursing evolved in recent years?
JM: Since we have been conducting off-site research visits since 1999, we have seen a significant change in the attitude towards the inclusion of off-site data acquisition options by the industry in general, particularly as the emphasis on the patient being acknowledged as a true partner in clinical research has evolved over the last decade. Technological advances, such as widespread use of wearables, electronic patient-reported outcomes, and telemedicine, coupled with a shift in the regulatory environment that puts the patient at the heart of the research process, has led to a significant shift in attitude as to what types of procedures can be performed off-site.
Sponsors recognize that they realize benefits with regard to recruitment and retention of patients when they make efforts to reduce the burden of trial participation on the patient and the family and off-site research nursing is a very impactful way to reduce that burden without compromise to their study design or the robustness of their dataset.
OSP: Could you please share some of the factors behind the changes?
JM: Certainly the increasing focus on patient centricity has driven a lot of dialogue over the years and we see industry actively engaging with patients and their advocates throughout the entire clinical development process. Patient advocates have become more involved in the design of clinical trials and most of that activity centers around either the data that the trial is looking to measure or on how to reduce the burden of participation.
According to the Deloitte Center for Health Solutions, over 70% of all clinical trial participants live more than two hours from the site that is conducting clinical research. We are seeing more and more companies hiring patient advocates or patient officers and working to infuse patient centricity through all aspects of their business.
A significant result of this investment in patient advocacy is that the patient voice is louder than ever before, and one of their messages is that they welcome the opportunity to participate in trials so long as that experience is not overly burdensome. The louder that those voices become, the more mobile research nursing is seen as a way to address that need.
OSP: What are the benefits behind using mobile nursing, as opposed to asking patients to travel?
JM: For patients, these benefits can be significant, particularly when one considers that patients are surrounded by families and caregivers whose lives are also impacted by the patient’s participation in the trial. On-site visits often don’t just require the patient to be at the site; other members of the patient’s support network are affected too in terms of time away from school or work, impact on children or siblings, etc.
For sponsors, the benefits can also increase the completeness and quality of their datasets. For example, a patient might be exposed to conditions when they travel that could affect their ability to perform on certain physical assessments (e.g., spirometry, muscle strength evaluations, quality of life assessments). Disruption of daily routines can also impact data quality. Mobile research nursing can alleviate these.
For the site staff, they are able to assess the safety of their patients at timepoints in the trial when they might not otherwise be able to due to the patient or family’s ability to attend a visit at a specific time, or, as we have seen recently, for other reasons, such as the current coronavirus public health crisis. Offering mobile research nursing can support recruitment and retention on a site-level basis, enhancing site success.
OSP: Can you think of any reasons why trial teams might be hesitant to turn to mobile nursing?
JM: Some trial teams may be hesitant to turn to mobile research nursing because they are unfamiliar with the process of how the nurses are identified and trained to be able to conduct the protocol-required assessments in an off-site setting. Some may have concerns about the quality of the data that are captured by the mobile research nurse. Some may have concerns about the nurses’ experience conducting clinical research trials and their understanding of GCP requirements. Some may be concerned about the cost of offering mobile research nurses and how that impacts their overall trial budget.
None of these concerns, however, should stop a trial team from exploring mobile research nursing as a patient-centric component of their clinical development plans. Trial teams should conduct research into potential mobile research nursing companies to ensure they are partnering with a company that addresses those concerns.
A top-notch mobile research nursing provider will be able to demonstrate a high level of oversight of their nurses, a broad training approach to ensure the nurses are truly able to function independently in the field, and who employs nurses that are eager to be integrated into the on-site trial team and committed to patient centricity and patient safety.
OSP: Can you share any stories, or statistics, on how using mobile nursing can help patient retention and study completion?
JM: Illingworth has a number of such stories. One that we would like to share involves the Duchenne muscular dystrophy (DMD) community. This particular trial required patients to attend weekly site visits over a period of years. This trial was experiencing a significant number of dropouts over time due to the demanding visit schedule, which was affecting school and work schedules, and, in some cases, required weekly flights and overnight hotel stays for the patient and a caregiver.
The pharmaceutical company running the trial approached Illingworth to see if mobile research nursing could help retain these families. We consulted with the company, and the protocol was amended to permit the use of mobile research nurses to administer the investigational product at the child’s home or school and collect relevant data.
Illingworth research nurses visited the children in their homes three out of every four weeks for a two-year treatment period, and, after the two years, not one child had dropped out of the study. Parents and their children were delighted with the rapport built up with their Illingworth nurse and it meant the loss of school time, loss of earnings for parents and general disruption was reduced to a minimum.
OSP: Do you have anything to add that I didn’t touch upon above?
JM: At Illingworth we are constantly reviewing our services and processes to ensure that patients, site staff, and sponsor companies have the utmost confidence in the commitment to reducing patient and family trial participation burden, while adhering to the highest standards of research excellence. We have been particularly focused on how we can keep patients engaged in clinical research during the coronavirus pandemic.
We are working to ensure our processes and delivery models are as flexible as possible for our clients to enable them to be to as responsive as possible during these uncertain times. We know that clinical trials offer hope to so many patients and their families and we endeavor to be a trusted partner in ensuring their continuity of participation.