The rising cost and complexity of clinical research is compromising new drug research and development. Speaking to BioSpectrum Asia, Ms Andrea Zobel, Senior Director of Product Management, Clinical Trial Supplies and Logistics at PAREXEL, highlights the importance of EClinical trials and their role in speeding up clinical research and encouraging discovery of novel drugs.
Speaking to BioSpectrum Asia, Ms Andrea Zobel, Senior Director of Product Management, Clinical Trial Supplies and Logistics at PAREXEL, highlights the importance of EClinical trials and their role in speeding up clinical research and encouraging discovery of novel drugs.
What are e-clinical trials and how are they conducted?
The term "e-clinical trial" is used for clinical trials in which technologies are used for documentation, processes and communication. This includes e-clinical technologies which have been available for several years, such as clinical trial management systems (CTMS), electronic data capture (EDC),interactive response technology (IRT) systems, electronic clinical outcome assessments (eCOA), and e-diaries for patients. These solutions have replaced paperwork and manual processes while enablingan increase in remote activities, such as remote monitoring in place of frequent visits tosites and investigators by clinical research associates (CRAs). Taking remote activities even further,a clinical site can be replaced by a ‘virtual site,’ with patients recruited prior to the study and connected to the investigator during the study conduct with the help of e-clinical technologies.In this situation, a patient is supplied with devices for communication, diagnostics,treatment, and the transfer of data and outcomes throughout the entirety of the study. Technologies are also available and in development for the drug product itself. Smart packages can monitor various data points and provide information about drug intake and therefore compliance of the patient. In the clinical supply environment, various technical solutions are available for tracking the location and status (i.e., temperature) of the drug.’Smart labels’ can be applied, which allow label information to be changed electronically without the need for relabelling. This allows just-in-time labelling in the case of pooled medication that can be assigned across multiple studies. It also enables the updating of expiry dates.Additionally, mobile applications connect drug packages via barcodes or sensors with databases and give patients, investigators, and all players in the supply chain access to important data.
Outline a few key trends in e-clinical trials space.
Two key trends in the e-clinical trials space arethe shorteningof timelines and the reduction of costs by replacing costly, manual processes with automated technologies. Patient and site centricity are also evolving due to e-clinical trials, with many sponsors considering how they can improve the patient and investigational site experience during a clinical trial. Personalized medicine is another trend being altered by e-clinical trials. While this trendreduces the number of patients who can take a certain medication, it also increasesthe need to find patients for clinical trials. To encourage participation, clinical trials should offer patients a convenient environment, easy access to trial information, and the option for simpler travel. Not only do these factors allow patients to participate easily, but they alsoprovide specialized investigators with the option to expand the region from where they can enroll patients.All of this is only possible when e-clinical technologies are available.
Please highlight some of the key drivers of the e-clinical trials market.
Patient and site centricity are key trends in the e-clinical space and drive implementation of e-clinical solutions. Many consumers now use health technologies in their daily lives in the form of wearable activity trackers. Users are oftenactive on social media, sharing their health and activity data with their community of followers. This trend toward shareable e-health is an important trend in healthcare, with e-clinical trials now designed to offer a similar experience. For some disease indications, devices are already established and regularly send health data to the attending physician. This enables ...
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