In a previous blog, we provided an overview of microsampling technology for preclinical and clinical trials, where small amounts of blood are withdrawn, in a minimally invasive, pain-free way, without the need for large-volume venous blood draws. The microsamples are stored and shipped at room temperature, not requiring the cold chain maintenance of traditional blood samples. In this blog, we delve deeper into the benefits and applicability of microsampling for clinical trials.
Optimal Study Types
Not all studies are appropriate for a microsampling approach. That said, some studies are ideally suited. Clinical studies involving pediatric or geriatric subjects, patients with particular physical limitations, as well as some preclinical studies, are excellent candidates for a microsampling approach. In these populations especially, smaller volume blood draws are preferable, and reducing discomfort, stress, and travel are major considerations. Studies that involve frequent blood draws can be simplified and expedited with a microsampling approach due to less time required between sampling events. In studies where samples are taken for additional assessments, like biomarkers and co-medications, this can be easily accommodated.
Additionally, the FDA’s Office of Generic Drugs (OGD) recently issued a COVID-19 related guidance stating that microsampling options may be considered for bioequivalence trials. Each study has its own particular requirements, so discussions with OGD and Altasciences are advised, to ensure all regulatory requirements are addressed.
Simplifying Trial Participation
Making clinical trial participation simpler is a key factor in speedy recruitment and maximum retention. Multiple trips to the clinical site for blood draws can be daunting for participants; relieving them of a large part of this logistical and time challenge can help improve commitment and capacity to complete the trial. Microsampling also makes clinical trials more accessible for subjects with limited mobility or difficult venous access, and those who are hesitant to participate in trials because of a fear of needles.
Currently, physical distancing is an important factor, particularly as it appears that COVID-19 public health measures will remain in place for some time to come. When used at the clinical site, visits are expedited by the simplicity of the procedure. The discomfort and recovery time associated with traditional blood draws are virtually eliminated. Clinic visits are quicker, faster, and less stressful with microsampling.
In a remote trial scenario, where a microsampling approach allows subjects to draw samples at home, the need to travel and to be in contact with others at the clinical site is dramatically reduced. Subjects can dose themselves, take their samples, and mail them back to the study site, without repeated interactions with study personnel or the need to travel.
For studies involving large blood volumes, microsampling can also reduce washout periods, expediting study completion and simplifying the experience for the participants.
Data Quality Considerations
The use of microsamples eliminates the need for cold chain storage and shipping, which simplifies the process of storage and analysis of the samples. Altasciences’ bioanalytical labs are renowned for their expertise with microsampling technologies and processes. We have developed workflows for many applications, and have the knowledge and capability to confirm high recovery rates and to cross-validate methods for future or later phase trials.
Speak to one of our experts about how microsampling can facilitate your programs.
|Altasciences' Resources||FDA Guidances|
|Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency January 2021, accessed April 23, 2021|
|Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers April 2021, accessed April 23, 2021|