Author: MRN
Each patient’s medical journey is their own – unique to them and their circumstances. However, depending on their diagnosis, there are some experiences that they will share with each other, no matter where they are in the world. A cancer diagnosis is one of these.
When navigating cancer, patients are likely to endure severe physical pain and discomfort, as well as the emotional distress that accompanies their diagnosis. Clinical trials offer oncology patients access to therapies that have the potential to increase their quality of life and/or their life expectancy. For some patients a clinical trial is the only answer to affordable healthcare. Furthermore, many patients often express their desire to help drive research forward, knowing that their participation today could one day help others in a similar situation.1
However, while there is a willingness to participate in trials, the reality is that they can place a significant burden on patients – especially those that still follow the traditional method of trial design and delivery – in the form of travel time, discomfort, and care team communication.2 Yet, these burdens can be alleviated through the use of more patient-centric approaches such as decentralized clinical trials (DCTs).
DCTs use remote or hybrid components that help make oncology clinical trials more accessible and easier for patients to participate in. To illustrate why DCTs or hybrid trial designs should even be considered let’s take a look at the obstacles of one patient’s clinical trial journey, which demonstrate just how difficult participation in traditionally designed trials is – even when it may not seem that way from the outset.
A Look Into Marina’s Journey
Marina was 35 years old and living with metastatic breast cancer when she began her clinical trial journey. Her cancer had progressed far enough that she was onto her third line of treatment, and she was faced with a choice. She could either enter a trial at a renowned national teaching hospital that was two hours from her home (in the US), or she could opt for the standard of care treatment – which at the time was gemcitabine and carboplatin. Marina had metastases in her lungs, liver, and bones; she was struggling with her breathing and experiencing excruciating pain levels.
Yet Marina wanted the chance to extend her life expectancy so she could spend more time with her two young children and family. It was with this hope that Marina opted to enter the trial. While the trial was not over an extended period of time, its regimen was intense. Marina would need to travel to the trial site 3 days out of 5 a week, for 4 weeks at a time.
During her visits, Marina felt that the trial team were only interested in any adverse events and her health status in relation to the investigational treatment. She felt they failed to express concern about how her cancer symptoms were affecting her, including her difficulty with breathing from the lung metastasis and the severe pain from the bone metastasis. This made Marina feel more like a data set rather than a person.
This, coupled with the grueling travel schedule, made the experience incredibly difficult for Marina and, after a brief time in the trial, she actually opted to withdraw and turn to palliative care instead. And we can see why – the design of the trial did not permit more time with her family, nor did it alleviate the pain and difficulty with breathing she was experiencing. Further it made her feel isolated – with busy trial staff unable to give additional time that is so often needed to help patients in trials feel like people, not data sets.
What we can observe from Marina’s experience is how trial design can impact a patient, and how it will affect them and their families. In this case, a lack of flexibility in the trial’s design meant that the site wasn’t able to treat the ‘whole patient’ – which in the end meant that they lost an articulate, lucid participant who could have provided elaborate descriptions of her symptoms and highly useful data.
How Home Trial Support – A DCT Solution – Could Have Helped Marina
If Marina’s trial had leveraged DCT or hybrid elements, such in-home healthcare or local community site visits, her overall experience of trial participation may have been very different.
One of the key solutions, Home Trial Support (HTS), would have seen Marina receive her treatments, as well as much of her relevant trial care, from her own home with an assigned healthcare professional (HCP). This would have immediately limited the amount of time she would have needed to spend traveling to the trial site and given her more time with her family just as she had hoped. Further, as she would have been receiving treatment in her own home, she would have had access to a safe, and comfortable environment – reducing any additional discomfit she may have experienced both while travelling and at site. Lastly, by working with a remote HCP, Marina would have had one-on-one support. Not only would this have provided Marina with someone who had the time to focus solely on her and her experience, but they would have played a critical role in providing the trial team with detailed information on Marina’s progress – providing them with a holistic view of her overall outcomes.
And Home Trial Support is not the only DCT or hybrid solution that could have worked for Marina. There are other hybrid options that involve everything from pop-up trial sites to local, community sites that could have been an option that limited travel and could have kept Marina comfortable and engaged in the trial.
It is the flexibility of these solutions that help reduce trial burdens, which in turn results in a more positive trial experience for all stakeholders and, most importantly, the patients. By leveraging DCTs effectively, sponsors help ensure that their trial succeeds while still providing patients with care that improves quality of life.
Learn more MRN’s full suite of DCT/hybrid solutions here.
References:
- Unger, Joseph S., et al. National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data (2024). Journal of Clinical Oncology, Volume 42, Number 18. doi:10.1200/JCO.23.01030.
- Kumar G, et al. Barriers for cancer clinical trial enrollment: A qualitative study of the perspectives of healthcare providers. Contemp Clin Trials Commun. 2022 May 28;28:100939. doi: 10.1016/j.conctc.2022.100939. PMID: 35707483; PMCID: PMC9189774.