With Covid-19 throwing clinical trial speed into the spotlight, we dive into the new innovations — like "organ-on-a-chip" tech and digital twins — enabling researchers to design better-informed, more efficient studies.
One effect of the current coronavirus pandemic has been the disruption of many clinical trials globally. As a result, there’s been increased attention on the gaps within the traditional paradigm of clinical trials. To address them, a more data-driven and patient-centric approach is necessary, at every step of the trial.
The initial step in a clinical trial is designing the study, which is critical in ensuring its success down the road. Study design can often be tasking, manual, and time-consuming for researchers.
This first step involves establishing important metrics such as defining the study population, the study cohorts to evaluate, dosing regimen of the interventions, to risks and side effects. These metrics, along with study timelines and site responsibilities, are then compiled into the study protocol document.
The study’s design also depends on its specific objectives, as different models may be considered. For example, randomized controlled trials (RCTs) — the gold standard in experimental trials — reduce bias by researchers, but take a long time to conduct. (In RCTs, both participants and researchers are “blind” to who receives the placebo or the treatment.)
Study design is a pivotal step, as poorly designed studies can impair patient recruitment and retention later on, causing delays. Needing to make major changes later on in the study can also inhibit their progress, incurring new costs and drawing out timelines.
To mitigate this, rising new technologies are offering researchers more precision and automation in designing more effective clinical trials, to help ensure study quality and timely regulatory approvals.
In part 1 of our series on clinical trial technologies, we look at promising new technologies with use cases in study design, including:
- Real-world evidence
- Digital twins
We also dive into Covid-19’s impact on clinical trials, and how researchers are approaching trials