Introduction [00:55]
Nadeeka Dias and Chris Watson from ERT discuss the race for a coronavirus vaccine and take a deeper dive into how sponsors and CROs can use technology to address the unique challenges of vaccine trials.
What are the specific challenges sponsors face in trying to create a COVID-19 vaccine? [02:10]
The real challenge is that the threat is now, so time is not on our side. However, good clinical research takes time. Because there are currently no approved vaccines or treatments for COVID-19, researchers are working on two types of trials: trials to test treatments for patients who already have the disease and trials to test a COVID-19 vaccine.
Even though these vaccine trials are accelerated and researchers and the FDA are moving quickly, it’s still going to take a lot of time to find a vaccine that works. While collecting data in a COVID-19 vaccine trial is going to be similar to any other vaccine trial, patient recruitment will be harder and sponsors will have to ensure that patients who are enrolled aren’t asymptomatic.
What are the challenges that are unique to vaccine trials? [04:21]
Vaccine trials are often developed in response to a new plague. Because of this, clinical development teams need to collaborate quickly to mitigate trial risks and delays. These studies also require a lot of physician oversight of patient safety and adverse events. Additionally, because vaccine trials often enroll large numbers of healthy volunteers across diverse demographics, it’s important to be mindful about how sponsors will effectively collect a very large volume of data. Lastly, sponsors should consider how they can keep their patients engaged, especially as the vaccine trial transitions into a more observational phase.
What are the challenges of using paper in vaccine trials? [06:05]
Because paper is a quick way to respond to the needs of vaccine studies, paper has always been the default option for data collection in these trials. What isn’t always taken into account is the volume of data that will need to be transcribed from paper into a repository; a typical vaccine trial can produce millions of data points. This volume of data should convince sponsors to contemplate using electronic data collection.
What advice would you give sponsors still using paper in their vaccine trials?[07:27]
It’s important to consider the impact of still using paper not just on data collection but on data analysis. If all of the data is regularly uploaded into an electronic database, the sponsor will likely be able to get results quicker and achieve database lock sooner compared to using paper. An electronic platform also provides real-time access to patient data, making it easier for clinicians to monitor patient safety.
How can sponsors already using a digital solution improve their data collection?[08:45]
Electronic always gives you better data quality, but to maximize it, you need to remember the end user: the patient. Engage with patients and facilitate their journey within the clinical space so ultimately they’re providing the quality data you need to determine the results of the study.
Flexible provisioning or BYOD is an electronic solution that makes electronic data capture very affordable for vaccine studies and integrates well into the everyday lives of patients.
How can a sponsor get started with electronic data collection?[10:59]
If sponsors have reservations about starting to collect data electronically, they can always run a small pilot study in one particular territory using these techniques. Comparing the results in that territory to results in the others should make it clear whether or not a sponsor should pursue electronic data collection in their studies.
Once this data is collected, what tools are out there for sponsors to use to help them analyze and visualize the results?[12:15]
Instead of putting data into the system at the end of a study (as is done with paper data collection), data is added to the system throughout the study. A strong reporting platform that can support analysis of millions of data points and give you early insights into how the vaccine is progressing is critical.
What are the ways we can use digital to keep healthy volunteers engaged in vaccine trials?[13:25]
Incorporating technology into a well-thought-out study design can improve long-term patient engagement. A key motivator for patients is knowing that a clinician is reviewing the information they’re entering in their diaries. A digital solution can be beneficial here; concerning data can be quickly flagged and sites can easily maintain communication with patients.
Any final thoughts?[15:15]
The circumstances we’re in are unprecedented, but there are many brilliant people working together to discover treatments and vaccines. It’s important that the industry supports these studies by implementing known and established best practices for data collection.
The search for a COVID-19 vaccine and cure is an ideal opportunity to embrace, not fear, the use of technology in clinical research. The patients and healthy individuals who want to be involved in these trials are embracing technology themselves; sponsors should follow their lead.