One of the endemic problems in clinical trials is patient recruitment. The ability to enroll often determines a trial’s success, and that can be especially challenging when recruiting patients with rare diseases, as the patient pool is severely limited.
According to research, there are over 40,000 clinical trials enrolling patients in the U.S. Some need over a thousand participants, whereby every participant must meet specific criteria to enroll. So maybe it comes as no surprise to learn 80 percent of clinical trials suffer delays because of these recruitment issues.
The Million Dollar Question(s)
So what lies at the root of the problem? How can sponsors rectify the issues concerning patient recruitment? With the influx of new technologies, it is quickly becoming possible to bring the clinical trial closer to home.
The mobile device, for instance, now makes it possible for patients and investigators to stay in close touch throughout the course of a study. As a result, sponsors are actively seeking to ease the patient’s life with fewer visits, giving greater autonomy to them over how they adhere to the trial. Of course, this raises questions over compliance, but that falls outside the scope of this particular article.
The Evolving Supply Chain
Nevertheless, what’s important to note is that as clinical trials become more digitalized, the clinical supply chain must evolve along with it. But how can the supply chain evolve to become more patient-centric?
- Direct-to-Patient shipping – The rise of direct to patient shipping has made processes more convenient for patients who might live too far from the trial, or who may have mobility issues. Sponsors must adopt DTP services to enhance recruitment and retention rates
- Leveraging IRT – With interactive response technology or IRT, sponsors now have the ability to gain access to patient data. What’s more, IRT systems can be used to provide further instructions to the patient on dispensation, altogether mitigating the risk of errors
- eLabels – Electronic labels are becoming more commonplace as they allow investigators to update information on a regular basis. This provides the patient with greater clarity on drug compliance
- Real-Time Monitoring – Through the use of wearable technology, investigators are able to monitor and manage their patients through real-time tracking. Real-Time monitoring, although in its infancy, has the potential to encourage greater patient compliance
- Smart Packaging – And on that note, new innovations in packaging are now making it easier for patients to adhere to treatment. With non-compliance a thorny issue after patient recruitment and retention, there is now a concerted effort for industry to switch from injected treatments to oral drugs
The Digitalization of Clinical Trials
The integration of wearable technology and smartphones in clinical trials, although in its early days, has already begun to show benefits. With real-time monitoring, for instance, being able to generate data means investigators can gather better, more improved patient-reported outcomes. Furthermore, direct to patient shipping affords greater flexibility to investigators, and more importantly, the patient. Patients are far more likely to remain compliant with the drug treatment, meaning improved subject retention for the sponsor. Lastly, with the cost of drug development continuing to sky rocket, the digitalization of processes drug development mean sponsors can bring clinical trials closer to the patient.
*Adapted from ‘Digitalizing your Clinical Supply Chain to create more Patient Centric Clinical Trials’ by David Dronneau (Sanofi)