In a recent white paper, Advarra discussed the challenges in the study startup process within the field of clinical research. It highlighted how modern technologies can address these challenges. Here are the key points it presented.
Challenges in Study Startup
Study startup processes in clinical research are often slow and prone to delays and errors. That’s because of manual workflows, which can lead to higher costs and delayed launches. External factors like labour shortages and competition further complicate these processes.
As decentralised clinical trials become more popular, technology will become a mainstay of the process. The white paper delved into the potential impact of technology adoption on enhancing the efficiency of study startup processes. It discussed four modern tech capabilities that could help solve the aforementioned problems.
Using standardised templates and enterprise research collaboration systems can streamline document exchange and automate key functions.
Technology allows for targeted, contextualised, and delegatable notifications to avoid information overload and ensure relevant stakeholders receive updates.
Global Program Visibility and Oversight
A shared global dashboard provides transparency into startup activities, helping teams collaborate effectively and identify areas where they may be falling behind.
Integrating various systems involved in clinical trials, such as IRB, eTMF, and training certification, enhances efficiency and reduces manual processes.
The text notes that not all systems need to be integrated but highlights key connections that sponsors often find most valuable:
- IRB to eTMF and eISF connections
- Training certification integrations
- Regulatory packet sharing between sites and sponsors
- Participant information integrations between systems
- Single sign-on for user convenience.
- Overall, the text suggests that by adopting these technological advancements and standardising processes, sponsors can achieve a more efficient and predictable study startup workflow in clinical research.
Whilst these tech solutions help accelerate the startup process for a clinical trial, the leading virtual research organisation (VRO), ObvioHealth, elaborates on one of them. According to the VRO, in addition to participant information integration, you also need electronic consent (eConsent) to “empower patients with information and sponsors with data integrity.”
Challenges of Traditional Informed Consent
According to ObvioHealth, paper-based consent can be inefficient. As a result, it can lead to diminished data quality and study validity. The company lists a few challenges this form of documentation may face.
- Informed consent is a crucial part of clinical trials, but time constraints often lead to inadequate participant comprehension. If a participant doesn’t understand what they are agreeing to, that consent might become invalid.
- Regulatory and protocol compliance for informed consent is essential, as failure to comply can lead to serious consequences. As a result, any findings recorded from a participant who hasn’t provided informed consent would have to be struck out of the study.
- That means inadequate informed consent can negatively impact study validity, participant safety, data accuracy, patient retention, engagement, and sample size.
Designing eConsent to Mitigate Failures
On the other hand, by harnessing the power of modern technology—or, by moving from paper-based consent to eConsent—you can mitigate almost all challenges. That’s of course as long as the eConsent has been designed well.
A well-designed eConsent solution can provide participants with information in a way that truly helps them make informed decisions.
- eConsent should be designed to be user-friendly and engaging for participants. This holds their attention during the onboarding process. As a result, when they agree to participate, they do so with a complete understanding of the information they are providing.
- Features like animations, self-guided videos, controlled scrolling, and quizzes can improve participant comprehension. These deviate from the traditional, paper-based, method of informing participants through written texts alone. As a result, they help keep the attention of the participants even through more detailed blocks of information.
- Digital repositories that store signed consent documents have the ability to enhance transparency and ensure compliance. This allows both the participant and the study leaders to (literally) be on the same page.
Benefits of eConsent
The adoption of eConsent has been greatly accelerated due to the COVID-19 pandemic, bringing substantial benefits to participants, sponsors, and regulatory bodies.
This technology empowers participants with knowledge, making the process more engaging and convenient.
It improves participant retention, compliance, and data quality, leading to better outcomes. It also supports regulatory audits by increasing transparency and prioritising participant understanding.
eConsent goes beyond digitising the traditional process; it fundamentally makes the process of delivering the trial more efficient.
It reduces the burden on participants, enhances their understanding, and increases retention and compliance.
Overall, eConsent benefits all stakeholders in clinical trials.
The best part is, eConsent isn’t just a matter of taking a traditional process and making it digital. As ObvioHealth puts it, “Instead, this small but essential step that initiates the patient into a trial is fundamentally improving trial delivery.”
Parul Mathur has been writing since 2009. That’s when she discovered her love for SEO and how it works. She developed an interest in learning HTML and CSS a couple of years later, and React in 2020. When she’s not writing, she’s either reading, walking her dog, messing up her garden, or doodling.