Vaccine clinical trials are very complex, around 12 years are needed between Phase I and Phase III studies until a license can be achieved, and the investment can be up to tens of millions of dollars. Another complexity is recruiting hundreds or even thousands of healthy subjects or subjects under specific demographic conditions; this increases the plight of the operations.
Indeed, the COVID-19 pandemic changed the vaccine clinical trial paradigm and helped to speed up the emergence of new methods for efficient recruitment, consent, and streamlined trial conduction. However, we can still point to some shortfalls in vaccine clinical trials. For example, large RCTs might include multiple sites, some of which are inexperienced and thus may get unreliable results affecting the final result for the entire trial (1).
The rise of clinical trial technology and new tools has happened hand in hand with guidelines, standards, and regulations like the ICH GCP, FDA CFR part 11, and EMA Annex 11. Vendors now deliver compliant and validated computer systems that are helpful tools for mitigating risks like human errors, increasing data quality across the trial, and digitalizing some of the stakeholders’ most draining tasks
Here are some ways technology enhances, closes gaps, maximizes, and do more efficient vaccine clinical research
1. Site Management: To address the challenge of recruiting a large number of participants in phases II and III, recruiting strategies can be enabled by tech.
Research sites can take advantage of management tools; for example, managing potential participant pipelines with a CRM-style tool can be way more efficient than spreadsheets. (Trial360). Study teams can streamline their operations through digitizing processes, gaining real-time data, and complete visibility of the enrollment processes.
Sites can take advantage of technology by acquiring tools like Electronic Medical Records (EMR) and e-signatures. The best option for technology adoption is to find a flexible architecture or on-demand software solution specially designed for sites.
2. Reporting & Surveillance: On the other hand, vaccine clinical trials require strict surveillance control of adverse events, randomization, population group segmentation, and often pediatric or elderly participants. Even in rural locations or vulnerable populations, monitoring the subjects can be enabled by eCOA/ePRO tools. For example, one of the main reasons for participants’ dropouts is the burden of traveling to the site; this can be reduced with a surveillance monitoring app.
Additionally, using these tools helps solve common problems like duplicate data, format differences, and data centralization.
3. Data Management: Evaluating vaccines’ safety, immunogenicity, and efficacy requires processing thousands of data sets. ESources tools like an eCRF can enrich data and allow advanced cohort analytics. High-quality data is powerful for decision-making and generating predictive outcomes for the sponsor.
A data quality guarantee, accuracy, and integrity can boost clinical trial and submission timelines. Besides, eCRFs are a fluent communication tool among monitors and coordinators, allowing automatic and manual queries right in the system to be resolved by the role in charge.
For low and middle-income countries (LMICs) still critical to close the gap and build their own scientific capability and infrastructure (2) in vaccines; for this purpose, technology can be a great ally, for example, in terms of standard unification and harmonization (ICH GCP) and fixing capability issues.
Even though the proportion of clinical data has increased in LMICs, it is critical to understand the landscape for the sponsors, CROs, and sites in these locations to get technology-based tools that meet their needs.
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- Janiaud, P., Hemkens, L. G., & Ioannidis, J. P. A. (2021). Challenges and Lessons Learned From COVID-19 Trials: Should We Be Doing Clinical Trials Differently?. The Canadian journal of cardiology, 37(9), 1353–1364. https://doi.org/10.1016/j.cjca.2021.05.009
- Grenham, A., & Villafana, T. (2017). Vaccine development and trials in low and lower-middle income countries: Key issues, advances, and future opportunities. Human vaccines & immunotherapeutics, 13(9), 2192–2199. https://doi.org/10.1080/21645515.2017.1356495