As the calendar turns to 2020, it not only marks the beginning of a new decade, but it also marks what will soon be the beginning of the third decade since Mednet was founded in 2001. Much has changed since then, particularly in the past 10 years. As we enter a new decade, the Mednet team has been reflecting on our past experiences while also anticipating the opportunities and challenges that lie ahead. We have identified three BIG trends that we see impacting clinical trials and will continue to do so for the foreseeable future. They are:
- Adaptive trials
- Data Standardization
- Increasing Complexity of Clinical Trials
In this first of a two-part series, we’ll look at the trends that continue to shape the way the industry conducts clinical trials. In part two, we’ll discuss how Mednet is addressing these trends in our product strategy. Let’s take a look at the individual trends:
In November 2019, the FDA issued, “Adaptive Designs for Clinical Trials of Drugs and Biologics – Guidance for Industry”. The Guidance defines an adaptive trial 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.”
This innovative trial design enables new efficiencies and flexibility in the conduct of clinical trials. It can help sponsors identify the patient population most likely to benefit from a treatment more quickly but also brings new requirements to the eClinical technology world. Access to emerging data and the ability to modify a treatment based on interim data is essential and requires unprecedented transparency and flexibility.
As adaptive trials gain in popularity, we can also expect to see new technologies emerging to address new demands for automation.
Data Standardization is another BIG concept that has truly changed the way sponsors (and health authorities) access, analyze, present and share data. CDISC standards continue to promote broader views of data, not only across phases of clinical trials, but across product portfolios and therapeutic areas.
CDISC standards are continuing to gain traction on a global basis. As of December 2019, CDISC standards are now the preferred standards for electronic data submissions in China. In addition, over 30 Therapeutic Area User Guides (TAUGs) have been published that extend the Foundational Standards to represent data that pertains to specific disease areas. And more are in development!
Finally, we want to mention the increasing complexity of clinical trials. This ongoing challenge is a result of numerous factors coming together in a dynamic environment. Data sources are quickly multiplying as wearables and IoT are incorporated into trials. As previously noted, novel trial designs are merging with great promise for more efficient trials. Technology environments where clinical trial data is collected, stored, analyzed and managed are evolving as quick as the new scientific methods. Patient participation, regional regulations and standards are also contributing to increasing complexity.
In many ways, the complexity reflects significant progress and innovation in science. At the same time, it still represents a huge challenge for clinical trial sponsors who are trying to infuse efficiency, maintain compliance and bring new therapies to patients. The world of clinical trials continues to evolve. The constant change and dynamic nature of study conduct is keeping eClinical vendors on their toes. Even the deployment of technology is on the move. We now see just about every technology vendor offering some type of cloud-based solution. As Gartner notes, “With the ascendency of the cloud, many vendors and service providers face an “adapt or perish” situation.”
Adaptive trials, data standardization and increased complexity will continue to dominate the clinical trial industry. All of these trends impact the people, processes and technologies related to clinical trials. Individually and collectively, they have the ability to transform how sponsors approach their R&D efforts. Mednet appreciates the influence of these trends and the opportunities they present. In our next blog, we’ll discuss how our product strategy helps sponsors address these trends while positioning them for success now and in the future and simultaneously getting the most from their eClinical technology investment.
To get the most from your technology investment, check out
our white paper: The
Pragmatic Modernization of Clinical Trials.
 Market Guide for Life Science E-Clinical Platforms. Analyst: Jeff Smith, Published: 21 June 2019