By Rick Morrison, cofounder and CEO, Comprehend Systems
The next several years are likely to be significant ones in the evolution of clinical trials. A number of new technologies are coming to the market that have unprecedented potential to improve trial efficiency, correctness, and, most importantly, safety. At the forefront of these developments is real-time alerting, a powerful new technology for helping each member of the research process do their job better at each stage of the research process. Although alerting is still a relatively new feature, many sponsors are already beginning to see the efficiency and safety benefits of incorporating them into their standard procedures.
Unlocking the Power of EDC + Mobility
Alerts have been made possible by two related advances in technology: the digitization of clinical trial data through developments like electronic data capture (EDC) and the prevalence of Web-enabled mobile devices like smartphones and tablets. Alerts are the key to unlocking the combined power of these two technologies because alerts allow a clinical trial system to be configured to recognize relevant information as soon as it is entered digitally. In turn, the data can be sent to the right person on their mobile device via text message or email wherever they are whether or not they are logged in to their computer workstation.
Alerts are highly customizable in a number of ways, including in terms of timing (i.e. immediate versus aggregated once per day) and the information they include. Alerts are also relatively easy to adopt with little investment in hardware or training as many people already have mobile devices and are comfortable using them in everyday life. Because of this flexibility and ease of use, alerts can bring improvements to many facets of the clinical trial process, including in safety, efficiency, and patient interactions, as described in more detail below.
Reaching the Holy Grail with the SAE Alert
Perhaps the most compelling use for realtime alerts is in the case of serious adverse events (SAEs). An alert that is configured to notify all relevant stakeholders as soon as an SAE is entered into the system can drastically reduce the delays currently associated with identifying, evaluating, and reporting SAEs. This is a benefit both to patient safety, as potential dangers can be addressed sooner, and to trial managers, who will be better equipped to comply with their SAE reporting requirements. In extreme cases, studies can be suspended faster before more participants are harmed.
Sponsors can also consider other types of safety-oriented alerts. For example, if a study has an overall patient deceased rate of 20%, an alert could be configured to notify the appropriate stakeholders if a particular site has a significantly higher or lower rate. Such alerts could broaden the way trial safety is monitored, quickly identifying problems even where an SAE has not occurred.
Securing Efficiency Gains with the Operations Alert
Alerts can be used to improve trial operations in a number of ways. For example, financial officers could be notified if spending starts to exceed the trial budget so that they can bring the trial back on budget. Concurrently, operations managers could be alerted if a clinical site is running low on certain supplies so that they can have additional supplies delivered, or a sponsor could be alerted if a certain patient screening question is disqualifying a large portion of potential study participants so that they can reassess if the screener is working properly. In each of these cases, alerts mean less time and less money goes to waste because potential issues are automatically brought to the attention of the right people much sooner in the trial process.
Heads Up, Patients — The Subject Side of Alerting
Alerts need not be exclusively sent to sponsors and managers. Alerts can also notify patients when they need to take action, which improves the research process and creates cleaner data. The most straightforward patient alerts are ones that remind patients that they need to provide data, either by entering an electronic patient-recorded outcome (ePROs) or visiting a clinical site. ePRO reminders are particularly powerful because they can be combined with other mobile applications so that the patient can take action immediately with little effort. For example, a patient in an antidepressant trial may receive a text message reminder to provide an assessment of their mood, and then the alert can automatically open another app on their phone with a mood survey to complete.
Alerts may also be combined with other developing mobile technologies. For example, some blood pressure monitors can now be continuously monitored by a smartphone app, so a patient who experiences an unexpected drop in blood pressure could be alerted to visit a clinical site immediately for further evaluation.
The Future of Alerts
Clinical trial alerts are still relatively new, but they are likely to rapidly become commonplace in the industry. The industry should also expect to see a great deal of innovation in the use of alerts. Forwardlooking sponsors will likely find beneficial uses of alerts we can’t even imagine today. As a result, alerts are likely to remain at the forefront of new clinical trial technology for the foreseeable future.