Belgium as an innovative clinical trial location in Europe has been saved
Belgium as an innovative clinical trial location in Europe
Well-designed clinical trials are of paramount importance in providing patients with fast access to new treatments. In recent years, efforts have been made to transform the traditional clinical trial into more flexible, innovative designs, leveraging advancing insights into genomics and digital technology. For the new clinical trial designs to achieve their potential in speeding up and improving patient access to innovative treatments, a collective understanding of the pros and cons of these designs and practical considerations for all stakeholders is of foremost importance.
One drug, one target, one trial
A traditional clinical trial typically tests one drug, one target at the time. While useful in many cases, this traditional clinical trial design is associated with long drug development cycles, high costs, and unnecessary delays in patient access for some treatments and diseases.
Innovative clinical trial designs
Innovative trial designs such as umbrella, basket, and platform trials (collectively known as Master Protocols) address these challenges by allowing the study of multiple diseases, multiple treatments, or both, in one trial. The parallel characteristics of these trial designs mean that fewer patients receive a placebo. In addition, Master Protocols are highly adaptable. Therefore, they have the potential to accelerate clinical trials decreasing the time from bench to bedside in diverse disease areas. Innovative clinical trial designs have proven to be especially relevant in oncology, neurology, rare diseases, and pediatric diseases, where time is even more valuable and populations are small and diverse.
The recent COVID-19 pandemic has also accelerated the uptake of other innovative clinical trial designs. These include seamless trials, with overlapping phases, and decentralised trials that test a treatment in the patient’s own environment, enabled by digital technology.
Endless design possibilities
Apart from the overall cost and time benefits, each of the clinical trial designs presented in this whitepaper offers its unique way to drive innovation. In addition, the designs can be combined, leading to endless possibilities in innovative clinical trial designs. Understanding the benefits and attention points for each of the designs helps to identify when to use them, which type or combination of types is most beneficial given the specific goals of a trial, and how to apply these designs successfully.
An increased understanding of these new trial designs on a country level would allow that meaningful steps forward can be taken to create an advanced ecosystem (e.g., improved data infrastructure, patient recruitment) that facilitates innovation in how clinical trials are carried out.
Belgium as the location for innovative clinical trials
The aim of this whitepaper is to provide an overview of innovative clinical trial designs and their associated opportunities and challenges from a scientific, practical, and regulatory perspective.
This whitepaper also includes a set of recommendations on the implementation of these innovative clinical trial designs in Belgium, in order for the country to maintain its position as the ambitious frontrunner for clinical trials in Europe in light of recent EU regulations.
Recommendations for Belgium
- Agree on a common understanding of innovative trials, their definition and intended use
- Stay up to date with the latest developments in the science and technology of innovative clinical trials and offer data sharing guidance, for example, by means of a knowledge sharing platform organised by a neutral party that bring relevant stakeholders together.
- Invest in statistical know-how
- Advance the understanding of biology and biomarkers
- Support the use and recognition of digital health technologies in clinical trials
- Support data sharing between hospitals and between the patient and the trial site by ensuring interoperability of digital data and building data infrastructure
- Ensure clarity and understandability of the informed consent