The discovery of new molecules and the successful execution of clinical trials to bring new therapies to market, coupled with the expansion of diagnostic platforms, continues to spur the global demand for clinical trial laboratory testing. We serve the clinical laboratory testing market, and our primary stakeholders include pharmaceutical and biotech companies, investigators, employees, job seekers and suppliers. What follows is an overview of the clinical trial laboratory testing market.
Central Laboratory Services
Central Laboratory companies provide a network of laboratories throughout the world in which laboratory testing processes are harmonized via the use of identical instrumentation, reagents, and standard operating procedures (SOPs). Prior to the inception of central laboratories in the mid-1980s, clinical trial testing was conducted in local laboratories. At that time the focus was testing related to patient safety. Today safety testing is still important, but since virtually every study has a specific set of biomarkers, testing related to drug efficacy is equally as important.
In addition to harmonized laboratory testing services, sponsors of clinical research rely on central laboratories to provide logistics for shipping specimen collection kits to investigator sites (doctors) and for shipping patient samples to laboratories for testing. A central laboratory provides specimen collection kits for blood, urine, tissues or other specimens, a courier network, biorepositories that collect, process, store and distribute specimens, project management and data management, which provides data transfers to customers often in very specialized formats.
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. Our Central Laboratory Services include:
- Project management
- Global investigator support services
- Courier services- sending kits to sites and samples to laboratories
- Lab data management services
- Lab monitoring services
- Specimen management and storage services
- Third-party laboratory management
- Near patient collection services
- Biorepository services
The testing of specimens in the laboratory is essential to supporting drug development. These tests are used to evaluate everything from the safety of a new compound to predicting which patients might benefit from a particular therapy. Test menus may vary by company, but include such categories as safety testing, immunoassay, flow cytometry, anatomic pathology, genomics, biomarkers, and bioanalytical. Sponsors may require/obtain laboratory testing and central laboratory services together from a single vendor or separately from multiple vendors. Q2 Solutions offers all of the testing categories above.
Advances in many areas of science are enabling the acceleration and expansion of clinical testing. Here are a few examples.
- AI (Artificial Intelligence) Driven Anatomic Pathology: Anatomic Pathology is the study of disease by the examination of human organs and tissues using gross, microscopic, and biochemical means. Digital pathology uses virtual microscopy and it focuses on data management from information that is generated from digitized specimen slides. The availability of ultra-fast scanning, high-resolution imaging tools will change how tissue samples on microscope slides are analyzed. The first step toward AI driven anatomic pathology is fully digitizing the information. Over time, the system will learn from supervising pathologists allowing faster analysis and higher throughput. Digitization of data allows easier access to specialized pathologists, and an improved process for evaluating samples. Automated analysis combined with artificial intelligence will improve diagnostic accuracy and accelerate discovery of new biomarkers.
- Flow Cytometry: Flow cytometry is a technology that analyzes individual cell types and can be used for the analysis of cells in tissues or tumors. Advanced flow cytometry techniques provide high quality data with minimal variability in the analysis of the tumor microenvironment. This has contributed to the accelerated growth in the area of personalized medicine, and in particular, immuno-oncology.
- Genomics: Genomics involves the analysis of the genetic makeup of an individual or tumor as determined by its DNA sequence. The use of genomics in clinical trials is growing rapidly as it becomes easier and more common to develop and apply genome-based strategies for the early detection, diagnosis, and treatment of disease.
- Sample Tracking Systems: With the growth in volume of oncology studies and more complex testing comes the need for more sophisticated sample tracking systems. At the same time, it’s important that sponsors know what samples they have access to and what consent they have obtained, from clinical trial participants, for any future testing use. This is the logic behind our acquisition of BioFortis, a leading biospecimen and consent tracking solution company.
- Blockchain: Blockchain, or Distributed Ledger Technology, allows a record of consensus between multiple parties with an audit trail of shared entries that has been validated by the participants. It has the potential to keep data and associated information around patient samples more secure. Sponsors and Contract Research Organizations (CROs) are evaluating its potential to address privacy concerns around patient recruiting and study conduct. Read our whitepaper about block chain related to patient samples.
Artificial Intelligence (AI)
- Predictive Analytics: As described above, AI can be applied to digital pathology to improve diagnostics. There is ongoing work to examine utilization metrics and habits around sponsor and site portals to drive improvements in how systems are used and how studies are monitored.
- Operational Forecasting: Implementing machine learning around central laboratory transactions can help improve forecasting around kits, reagents, instrumentation, and staffing.
Patient Care Approaches Impacting Clinical Trials
- Point of Care (POC) Testing in Clinical Trials: POC devices are becoming more prevalent for patient care outside of clinical trials but are also gaining traction within clinical trials. Initially clinical trial investigators screen patients via point of care pregnancy test kits. More recently investigators are using devices for influenza, diabetes, and other testing to help screen and enroll patients during a single visit to facilitate challenging enrollment goals.
- Virtual Clinical Trials: The use of telemedicine, mobile device health tracking systems, and homecare have become more and more prevalent for patient care, and these same technologies are now being used in clinical trials. We have supported many trials requiring Near Patient Collection (NPC), or the collection of specimens away from an investigator site and close to a patient, via local draw centers, nurses, and phlebotomists. Our experience in working with the key virtual trial CROs has helped us solidify our belief that more and more trials will utilize alternative and more convenient approaches for patients.