Infectious diseases are emerging and spreading at an accelerated pace. As our global population grows — from 7.8 billion in 2020 to a projected 9.9 billion in 2050 — vaccine development is essential to help control existing and future pandemics.
Because viruses can spread around the world in months, the ability to accelerate clinical trial timelines without compromising quality is increasingly essential. When the World Health Organization declares an infectious disease a public health emergency, drug developers must respond immediately to recruit participants and move vaccines through clinical trials.
While funding helped COVID-19 vaccine candidates move through assessments, clinical trials, and Emergency Use Authorization in record time, digital technology ultimately kept other studies on track during a period of extreme disruption. Videoconferencing, mobile technology, and remote patient monitoring allowed patients to participate from anywhere. Real-time access to direct data capture (DDC), electronic patient-reported outcomes (ePRO), and electronic clinical outcomes assessments (eCOA) enabled study teams to monitor data remotely, allowing them to operate safer and faster.
Case Study: Gathering Patient Data During a Pandemic
In the midst of the pandemic, a leading pharmaceutical company had a Phase III trial planned for a SARS-CoV-2 prophylactic therapy. The company needed to evaluate post-exposure prophylaxis and pre-emptive treatment in 1,000 patients.
The snag: these patients all lived in long-term care facilities (LTCF), and some may have been exposed to the virus.
Ultimately, these high-risk patients could not visit sites in person, and telemedicine was not an option. With the help of technology and several home health nurses, the sponsor was able to efficiently collect the data needed to complete the study.
How It Happened
The sponsor used a direct data capture (DDC) system that allowed it to collect data and supporting materials remotely. Instead of gathering the data and transcribing it later into an electronic data capture (EDC) system, the DDC system captured data directly. The system accepted both structured and unstructured data: including eCOA and ePRO, direct data such as vital signs, and audio, video, and photos.
Instead of using telemedicine, the sponsor dispatched traveling coordinators and nurses to each of the 82 LTCFs. Nurses, wearing appropriate PPE, took patients' vital signs and completed eCOAs. Rather than write down results on a paper form, which a member of the study team would have to transcribe later into the EDC, nurses entered readings into an application installed on a tablet that sync'd to the DDC platform.
The DDC platform was also designed to work with and without internet access — an important feature in unpredictable environments. Automated edit checks ensured data was entered completely while the coordinator still had access to the patient. Barcode readers facilitated accurate record keeping.
To enhance security, devices were specifically assigned to individual users. This procedure also facilitated FDA requirements for ALCOA+ data integrity (attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available).
The Result: Study Complete With Weeks to Spare
By pivoting from the traditional EDC model to an eSource DDC platform, the sponsor not only kept its clinical trial on track, but also completed study startup in 10 weeks — substantially quicker than traditional methods.
By using eSource technology and mobile clinicians, the sponsor made it easy and convenient for patients to participate. This type of remote participation is a cornerstone of decentralized clinical trials, a full- or partly virtual design that's received increased attention over the past year.
It's difficult to predict when new viruses will emerge and how fast they will spread. When they do, vaccine and therapeutic developers can use eSource platforms to respond quickly and get the data they need to help protect the public from infection.