The ethical and financial benefits of patient-centric sampling have intensified, as biopharma companies seek ways to improve patient recruitment and retention in their clinical trials. In this blog, Covance Director of Bioanalytical Science, Stephanie Cape, PhD, discusses the benefits and evolution of - as well as what’s next for - patient-centric sampling.
What is patient-centric sampling?
The fundamental idea of patient centricity is focused on putting the patient first. Within the context of clinical trials, we need to think about the experiences of the patient, including how we are collecting the necessary samples for testing in support of the study aims. We need to innovate and evolve to achieve the same - or improved- outcomes, while also making the process less painful and more convenient for a better patient experience. A lot of the research and development in the patient-centric sampling space is focused on enabling at-home or remote sampling. For instance, if I'm in a situation where my health is compromised, I definitely want flexibility for myself and my family to have samples taken at home where I'm most comfortable. It's really all about what's best for the patient and it's our obligation as scientists to enable that. Additionally, flexible sampling options will increase the ability to reach new patient populations, for example in remote geographical areas, as well as support on-demand sampling, giving us the ability to collect very targeted data that we've never been able to access before.
How has patient-centric sampling evolved?
There is a long history of driving toward increasingly lower sample volumes. One of the most familiar examples is the application of dried blood spot (DBS) technologies for newborn screening to detect metabolic disease. Adoption of this approach in the regulated bioanalysis arena was initially focused in the preclinical space with an aim to reduce the number of animals needed to support development programs. Through this deployment, we gained experience and learned the analytical challenges and limitations of dried matrix techniques. This accumulated expertise is now being applied to address many of the previous concerns through design of new sample collection devices allowing implementation on a broader scale.
What are the advantages of patient-centric sampling?
Patient-centric sampling techniques that allow for remote sampling offer flexibility to meet the needs of the patient while potentially providing more meaningful data. In the drug development space, the technology adds significant value when considering particular disease states, especially those for which data needs to be collected after an event such as a migraine, as well as in remote geographical areas. It also makes it easier to participate in a clinical trial as this can open the opportunity to more patients to receive effective therapies and, in doing so, also decrease recruitment time and increase retention. Also, with the application of dry samples, it may be possible to eliminate the costs and complexity of cold chain sample shipments. These novel sampling techniques will not be appropriate for all applications, but as we start to realize the benefits of the technology, I think we’ll start to understand their immense potential value.
How can we achieve implementation of patient-centric sampling?
The successful implementation of this technology requires collaboration and engagement of all the teams supporting the project. As these new technologies use different sampling approaches compared to traditional liquid samples, the sample collection process is a major focus for ensuring the samples are collected consistently and correctly. Training and ease of use of the devices are critically important. On the bioanalytical side, additional considerations for this sample type include sensitivity limitations, stability considerations and the potential for recovery to change over time. These challenges all exist with traditional samples as well, but need to be reconsidered when using new collection devices.
In addition, there are some concerns within the industry about how regulatory authorities will view the data even though the regulators have been quite vocal that they are supportive of innovation. To that end, there is some additional work to conduct bridging studies if you're comparing data from samples collected traditionally to those collected using micro-sampling techniques.
While patient-centric sampling does require upfront investment, the potential return on that investment is enormous. People are coming at this from a lot of different perspectives, all recognizing the potential, and collaborating to move this forward. The industry is gaining momentum to achieve widespread implementation and I’m optimistic that this technology will disrupt the paradigm and improve healthcare.
Learn more about how the Covance team is exploring patient-centric sampling at this year’s Land O’ Lakes Annual Bioanalytical Conference, July 15-18 in Madison, WI. In addition to moderating a panel on patient-centric bioanalysis, the team will be presenting a poster on “Analysis of the Monoclonal Antibody Adalimumab in Human Blood Collected via Volumetric Adsorptive Microsampling (VAMS) Technology and Utilizing LC-MS/MS Detection”.