Author: MRN
In a previous blog, Bringing Clinical Trials To Communities With Home Trial Support (HTS) & Site Support, we examined how MRN’s patient-centric solutions are bringing clinical trials into more communities and reaching not only a larger number of patients, but also more diverse population groups. By enabling this, Sponsors are able to develop medicines and therapies that are more representative of those in need of them – a win for healthcare and for patients.
The key to making diversity in clinical trials a regular thing is surprising simple (in theory anyway). And it’s a concept that we have all become increasing comfortable with since 2020, when the Covid-19 pandemic hit, and we as a global collective, were forced to find an alternative way of working and living – remote, and then as Covid slowly eased off, hybrid options. Especially as people discovered how much time was lost on the daily commute. Hybrid options were not just applied to our working lives, but also to our healthcare – especially in clinical trials. The idea that study visits did not always require a patient to come to the trial site did two things:
- It instantly relieved the workload from study sites, who were battling to keep going amid staffing shortages, incredibly long shifts and just the sheer volume of people needing help.1
- It ensured that those who were more vulnerable were able to continue to participate in potentially lifesaving clinical trials, without the risk of falling prey to infections they are more likely to pick-up during a visit to the study site.2
The result in the adoption of this model allowed thousands of clinical trials to continue – giving patients what they needed, sponsors the ability to continue to support clinical research and sites the breathing room required to continue to function while overseeing research.
And the value of hybrid and DCT approaches remain as strong as ever – patients continue to enroll in and remain in trials with options that allow for at least a mix of in-home and site visits. The reasoning behind this is simple patients and their families, now more than ever, have realized the value of time, and just how much is lost commuting and how expensive life logistics can be when you forced to spend extended daily hours away from home…even if that’s just to work and back.3,4
Home Trial Support solutions essentially remove the traditional barriers to patient participation, as they have far greater geographical reach as well as the flexibility to be tailored to not just each trials needs, but also the individual patient’s needs. And it goes so much deeper than just limiting the amount of travel patients would traditionally need to undertake to participate. HTS Home Healthcare Professionals (HCPs) can connect with their patients and their families on a deeper level – they are solely focused on the patient when with them and have the time to answer questions and alleviate fears that the patient may have during treatment. With 47% of patients reportedly dropping out of studies due to fears of study procedures,5 having someone that the patient repeatedly interacts with to answer their and their families’ questions is invaluable for patient retention.
Sites also benefit from HTS solutions, because, just like patients, there are time and logistical burdens that sites are still battling in the post-pandemic world. One of the greatest issues faced by sites is staff turnover and subsequent shortages,6 and it can have a direct impact on patient’s opting to withdraw from a study – 55% of patients have listed lack of a personalized approach to their care by the site staff as a reason for withdrawal from a study.5 HTS can aid in relieving that burden. As noted above HCPs have the time and opportunity to provide that dedicated care. They can further reduce this burden by taking on procedures that can take place in the patients’ home and, in many instances, the in-home administration of the investigational medicinal product (IMP) (which in some cases has the added benefit of being representative of real-world administration once it has approval).1
It is not only traditional sites that can benefit from HTS – pop-up or mobile sites also stand to gain from HTS solutions. While they are able to bring the site to the patient in order to perform those treatments that need to be done on a clinical environment, HTS HCPs are able to perform the visits and checks that don’t need to be completed in a clinical environment, supporting the pop-up site in reaching more patients by removing the time it takes to complete tasks that can be done in the home.
Home Trial Support has been invaluable to keeping clinical trials going, with or without a pandemic as a driving factor. They can return a cherished and highly valuable resource to sites and patients – time, and help bring more lifesaving, and representative, medicines and therapies to market, faster.
References:
- Betcheva L, et al. Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment, Ther Innov Regul Sci., Sept 2023;57(5):1081-1098. doi: 10.1007/s43441-023-00540-2.
- Muñoz-Ramírez S, et al. Feasibility of a hybrid clinical trial for respiratory virus detection in toddlers during the influenza season, BMC Med Res Methodol 21, 273, Dec 2021, https://doi.org/10.1186/s12874-021-01474-9, Last Accessed Mar 2025.
- Barton, C. Will Decentralized Clinical Trials Become Mainstream?, PharmaTech.com, Mar 2025, www.pharmtech.com/view/will-decentralized-clinical-trials-become-mainstream-, Last Accessed Mar 2025.
- Apostolaros, M. B. Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative, Therapeutic innovation & regulatory science, 54(4), 779-787. doi: 10.1007/s43441-019-00006-4
- Poongothai S, et al. Strategies for participant retention in long term clinical trials: A participant -centric approaches, Perspect Clin Res. Mar 2023; 14(1):3-9.doi:10.4103/picr.picr_161_21.
- Peleg I. Can Clinical Trials Overcome Their Staffing Problem?, Applied Clinical Trials, Nov 2024, https://www.appliedclinicaltrialsonline.com/view/clinical-trials-staffing-problem, Last accessed Mar 2025.