Q & A
Q; What is Patient Centric Sampling?
A: Patient centric blood sampling is a means to improve compliance and lower anxiety, complexity and cost related to the blood collection process. This is accomplished by making the process more convenient and more comfortable than traditional blood sampling through the use of devices and technologies. With a patient centric sampling approach, individuals may collect their blood samples remotely by themselves or with the help of a caregiver. Where appropriate, these collections may take place in the patient’s own home.
Q: What are the issues with the traditional ways of getting blood?
A: The traditional blood draw involves trained health care practitioners, and oftentimes require a trip to the clinic. In addition, venepuncture is not a pleasant experience for most and it poses the risk of needle stick. Finger or heel sticks are still quite painful. Children in particular can really benefit from this less invasive procedure, especially when frequent sampling is required.
Q: Who can use PCS technologies?
A: Anyone as long as they are appropriately trained and do so following local regulatory requirements.
Q: Where can I use PCS technologies?
A: At any bodily location as defined by the manufacturer.
Q: What type of samples can be taken using these technologies?
A: A variety of sample types are available depending on the technology, including but are not limited to whole blood, separated blood, dried blood spot, dried plasma.
Q: Where can PCS technologies be used?
A: These technologies can be used wherever blood samples are currently collected, for example the doctor’s office, or a hospital / clinical setting. However, the technology can also be used in locations that are more convenient to the patient, for example in their home, or at a pharmacy (where local laws allow). The technology also opens up the consumer-led healthcare market by enabling a plethora of quality wellness tests to be performed. In pharmaceutical drug development, Patient Centric Sampling improves the clinical trial design and conduct, facilitating trial enrolment and helping researchers gather additional data. The innovative sampling methodology also provides the monitoring bodies approaches that are more feasible to deploy, especially for the cases of population and longitudinal studies.
Q: How can PCS technologies help in pandemic situations?
A: Rapid and reliable diagnostic testing is critical in pandemic situations such as during SARS, MERS, COVID-19 outbreaks. PCS technologies offer blood sampling that can be self-administered by individuals while in quarantine, reducing unnecessary exposure of healthcare workers and uninfected populations. More importantly, PCS has the ability to extend central lab testing quality to both laypersons and professionals.
Q: How much would Patient Centric Sampling cost?
A: Deploying PCS technologies will require an upfront investment, but it is considered that ultimately there will be cost-savings in the long run when all aspects of the total cost of blood sampling and analysis are taken into account.
Q: What are the benefits for healthcare providers?
A: PCS technologies add flexibility to sample collection. It allows remote blood draw with added data points, while using less resources from the clinic. It offers a patient-friendly way of remote safety- and drug-monitoring. PCS can also serve a critical role in helping professionals get back to work in the face of pandemic outbreaks.
Q: What are the benefits for consumers who want to monitor their wellness?
A: PCS technologies allow consumers to take control of their own wellbeing through varieties of consumer-led health screening products. It enables a consumer-friendly way to gather quality wellness data allowing individuals to make their own decisions on wellness and lifestyle.
Q: What are the benefits for clinical trials?
A: PCS technologies enable a patient-centric decentralized clinical trial model, allowing remote sample collection. It is considered that this will improve enrolment and retention rates. Furthermore, it enables sample collection at time of disease flare-ups or drug administration gathering more relevant data. PCS technologies have also demonstrated the ability to become connected to the internet and to transmit valuable information to data repositories. Ultimately this enables the collection of more pertinent clinical data, while saving on the study budget.
Q: What are the benefits for governing and monitoring bodies?
A: PCS technologies can improve public engagement with healthcare and compliance with taking medicines. It can be used to set out new standards for other healthcare services and/or technologies. It also provides an innovative solution in sports medicine and anti-doping communities.
Q: How do the results from PCS technologies compare with the standard collection and analyte testing?
A: The result comparison is analyte-dependent. Some measurements are validated to show good concordance between results from PCS technologies and those from standard blood collection. PCS technologies have also demonstrated major differences in usability compared to standard blood collection methods, which can lead to improved compliance and satisfaction.
Q: Do PCS technologies give me a result at the time of collection?
A: No. The sample needs to be sent to a laboratory for analysis and where it is appropriate, results will be routed to you via the normal channels.
Q: Are these PCS technologies regulated and validated?
A: Because these devices are involved in the generation of a test result, most of the PCS technologies have completed, or are undergoing regulatory review/approval. Many of the technologies are categorized as medical devices and have been granted 510(k) and/or CE mark where the quality and safety profile has been reviewed.
Q: Are these PCS technologies regulated and validated?
A: Because these devices are involved in the generation of a test result, most of the PCS technologies have completed, or are undergoing regulatory review/approval. Many of the technologies are categorized as medical devices and have been granted 510(k) and/or CE mark where the quality and safety profile has been reviewed.
Q: Who are the members of the PCSIG?
A: This group currently includes pharmaceutical companies, device manufacturers, contract research organisations, academics, clinical laboratories and consultants, but is open to anyone that is interested in helping the progression of these blood sampling approaches to being used routinely.
Q: What is out of scope for PCSIG?
A: We do not engage in any activities in marketing or promoting any particular patient centric sampling method or analysis technology. Nor do we share any company proprietary intellectual property.
Q: How can I take part in PCSIG?
A: If you are actively involved in the development, implementation or utilization of patient centric sampling technologies, or are involved in the downstream analysis of samples generated from such technologies, please reach out to the site admin and find out how you can contribute to the group.