Clinical Laboratory Solutions for Decentralized Clinical Trials
At-home sample collection and testing can fuel the fast growth of decentralized research
The COVID-19 pandemic has accelerated the growth of decentralized, virtual, and hybrid clinical trials, a trend that will continue in the coming years.
In a global survey sponsored by PPD, biopharmaceutical and biotechnology companies reported that between 2020 and 2021, only 46 percent of their clinical trials were on-site, while 39 percent were hybrid, and 15 percent were fully decentralized, a shift further enhanced when considering trials planned for later 2021 or 2022 (41 percent, 42 percent, and 17 percent, respectively).
Conducting clinical trials away from a central research facility enhances the patient experience by making participating in trials more convenient and less disruptive to daily life, especially for individuals with mobility issues or who don't live near a clinical trial site. In addition, decentralized trials can improve participant compliance and retention, enhance representation in research, and reduce study costs.
With sponsors planning decentralized clinical trials as a permanent part of their clinical development efforts, it’s clear that patient-centric sampling is here to stay. To be part of the ever-increasing ecosystem of direct-to-patient partners and solutions, clinical labs need to be ready to implement solutions around at-home sample collection and testing. Read on to learn more about the services and solutions clinical labs can offer to fuel the fast growth of decentralized research.
Mobile nursing and phlebotomy teams
When clinical laboratories participate in hybrid trials, they can deploy nurses or phlebotomists to collect blood, urine or hair samples during study visits at patient service centers, retail locations, or health clinics.
Mobile nursing and phlebotomy teams can also collect biological specimens at a patient's home, workplace, or vacation destination. In addition to extending the reach of clinical research, mobile lab sample collection enables fully decentralized research, enhances the patient experience, improves retention, and drives efficiency by increasing adherence to the study requirements.
"Getting the most value from decentralized clinical trials will accelerate the time to market for new drugs, devices, and therapies."
By using mobile nursing and phlebotomy services, sponsors can include more measurements in a study due to convenience. Phlebotomists, for example, can collect biological specimens and basic biometrics like height, weight, blood pressure, and electrocardiogram. In addition to collecting specimens and basic biometrics, home nurses can manage patient consent, administer investigational products, and conduct patient evaluations and physician-guided physical examinations.
To comply with the requirements of specimen collection, processing, and shipment, clinical labs must provide nurses and phlebotomists with training and standard operating protocols. Some jurisdictions (such Ontario in Canada and California in the US)also require phlebotomy certification or a license to draw blood.
Self-collected patient specimens
Having patients self-collect DNA via saliva and cheek swabs, as well as self-collect urine and stool samples, is relatively common in clinical trials. More recently, remote blood collection devices have offered a convenient and virtually painless blood collection experience. For example, the Tasso-M20 device collects dried blood samples from capillaries in the upper arm with the push of a button and is intended specifically for use in decentralized clinical trials. Among other applications, the Tasso device has been used to measure drug levels in patients treated with an anti-A therapeutic antibody.
Patients self-collecting specimens in decentralized clinical trials involves creating specimen collection kits specific to each study and visit. Usually, a central laboratory designs, assembles, and sends specimen collection kits along with requisitions, instructions, and shipping materials directly to patients. The patient then collects, potentially processes, and returns samples to the laboratory for testing.
Self-collecting samples offers patients autonomy and convenience. It can also address common barriers to clinician-dependent or clinic-based diagnosis, such as lack of privacy and concerns stigma around particular health conditions.
Despite the advantages mentioned above, having patients collect their own specimens requires monitoring and extra patient support. This may include training patients on proper sample collection, processing, and shipment, as well as incorporating participant reminders via phone, email, or text (SMS) to ensure they follow the self-collection protocol. Moreover, remediation measures, such as nurse or phlebotomist rescue, must be in place if a patient cannot extract an adequate sample.
Using self-collected samples is one way of expanding the use of decentralized clinical trials. Once manufacturers improve devices and laboratories solidify operational processes, sponsors, investigators, and patients will benefit even more from this approach, especially when appointments and capacity in clinical spaces are limited.
Point-of-care testing in decentralized clinical trials
In today's connected age, the point-of-care testing (POCT) ecosystem is more diverse than ever. From basic POCT, like pregnancy, glucose, and oxygen concentration, to nasal swabs and biomarker testing, POCT technologies have been used broadly in decentralized clinical trials worldwide.
POCT devices provide rapid diagnostic results in non-laboratory settings, which increases efficiency and demographic representation in clinical research, optimizes patient recruitment, and often minimizes costs within a clinical trial. In addition, the rapid results of POCT allow medical decisions to be made more quickly.
"Clinical labs looking to incorporate POCT into their solutions for decentralized clinical trials should also plan to integrate the devices into their lab’s overall IT infrastructure."
As more POCT devices enter the market and become easier to use, clinical labs need to be ready to adopt this technology, manage its distribution, support patients and investigators, and provide ongoing technical support.
Clinical labs looking to incorporate POCT into their solutions for decentralized clinical trials should also plan to integrate the devices into their lab’s overall IT infrastructure. POC devices have used several connectivity methods in the past several years. For example, the Siemens DCA Vantage® Analyzer, a POC device for monitoring glucose levels and detecting early kidney disease, allows data exporting to computers through USB flash drive. Similarly, the CoaguChek® INRange, a POC system intended to monitor coagulation, has Bluetooth or USB connectivity. This connectivity removes the need to manually enter results, reducing errors. Once data is transmitted to clinical trial laboratory systems, it can be used for data mining and research purposes.
While using POCT in clinical trials has great advantages, product development and the regulatory environment continue to evolve Regulations governing these technologies also often differ country to country, presenting challenges for clinical trials that span several countries. Therefore, clinical labs involved in decentralized research must closely monitor the regulatory landscape and confirm that POC devices and tests adhere to local jurisdictions and regulatory guidelines.
Decentralized clinical trials ultimately benefit patients
By making the most of at-home sample collection and testing, clinical labs can have a pivotal role in making clinical trial processes more efficient. Finally, and most importantly, getting the most value from decentralized clinical trials will accelerate the time to market for new drugs, devices, and therapies and better serve study participants by decreasing the burden of trial participation.