On May 20, we celebrate Clinical Trials Day. The day of awareness is an opportunity for research teams, patients, and the public to recognize how clinical trials have shaped modern medicine. It’s also a chance to reflect on how far we’ve come – and the amazing impact clinical research has made – on our understanding of diseases and their causes, treatments, and prevention.
We commemorate the day back in 1747 when James Lind started what is considered the first randomized clinical trial. It would be interesting to see what James might think of the progress made in clinical research in the past 275 years following his efforts to research treatments and understand scurvy.
Though Lind’s work inspires today’s clinical trials, and randomization is a critical principle, little else resembles his early efforts. Clinical research has evolved and continues to grow to bring together innovative science and technology to address patient needs.
The Clinical Trial Landscape
The clinical trial landscape has been rapidly evolving over the past few years. Clinical trial designs are becoming increasingly complex. Adaptive designs are being used to accelerate research. In November 2019, the US FDA published, “Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry”. The Guidance notes “an adaptive design is defined as a clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial.” The agency has encouraged innovative designs such as master protocols because they support the research of multiple investigational drugs or biologics, multiple disease types, or multiple patient populations under one clinical trial structure.
In November 2020, the FDA published guidance on the topic: Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs. The guidance suggests ways to expand clinical trial eligibility criteria with inclusive trial practices and designs. It also describes how sponsors can increase enrollment of underrepresented populations in clinical trials.
Simultaneously, the industry has witnessed the advent of decentralized trials (DCTs). These are also known as remote or virtual trials while a trial that has some remote components and some traditional components is known as a hybrid trial. The concept of DCTs advanced rapidly during the COVID-19 pandemic where many site teams and patients had to interact virtually due to regional lockdowns and quarantines.
Factors Adding Complexity to Clinical Trials
There are a host of other factors changing the clinical trial landscape. Sponsors are partnering with contract research organizations (CROs) around the globe to take advantage of specialized expertise, additional resources, and geographic reach. Decentralized trials are becoming more popular because of the potential to reach broader populations. Clinical data standards (CDISC SDTM, ADaM) are maturing and support greater access and sharing of critical trial data.
A new focus on patient engagement and the patient experience elevates the patient voice in trial design and conduct activities. At the most basic level, in an area where patient recruitment and retention are critical to the success of a trial, patient engagement methods are imperative to attract and retain study participants. At the same time, new data sources and the increasing focus on virtual and decentralized trial models is creating a greater focus on the patient, or study participant, and it is making them a direct line of data collection. In these models, the patient takes on a more active role in the study by directly tracking and reporting data and outcomes.
Clinical trial sites are forming site networks that offer access to multiple sites through one entity and boast a consistent, simplified, and efficient approach. Multiple technology users at these sites must access critical information about the patient, regulatory reporting requirements, and other trial-critical data throughout the trial.
The Impact on Clinical Trial Technologies
While the science and innovation are exciting, growing complexity requires new technology solutions to support clinical trial planning and execution. Automation is key, but flexibility is essential.
Technology platforms must deliver a simplified and consistent user experience while still supporting a myriad of trial designs. Whether the user is part of a site team or a sponsor’s clinical operations, clinical data management, or biostats team, they must be able to access role-appropriate information quickly and efficiently. Modern clinical trials demand that technologies support multiple roles across the lifetime of the trial. They must also be easy to learn and use to encourage site adoption.
Today, flexible technology solutions are absolutely essential to support complex clinical trials. Rigid technologies and point solutions create bottlenecks and result in delays that can impact the success of the clinical trial. It is clear that technological flexibility can empower research teams and will help to drive new innovations in science.
Happy Clinical Trials Day (#CTD2022) to all our colleagues in the clinical research arena navigating the complexities and accelerating results. To learn more about our flexible clinical trial solution and how we can help support today’s demands, please contact the Mednet team.