Clinical trials are essential for evaluating the safety and efficacy of new treatments and interventions. Traditional clinical trial designs have limitations, such as long duration, high costs, and limited flexibility. In recent years, there has been a growing interest in innovative approaches to clinical trial design, particularly using adaptive and platform trials.
These approaches aim to enhance efficiency, reduce costs, and accelerate drug development. We will explore the concepts of adaptive and platform trials and discuss their potential benefits in advancing medical research.
1. Adaptive Trial Design:
We can categorise adaptive trial designs into two types: sequence and sequence-to-sequence. Sequence design involves using a randomised sequential block design to conduct the trial. In the sequential block design, patients (n=X) with multiple levels of severity are enrolled sequentially in each investigation arm. It is beneficial in clinical trial services.
After an interim analysis, the patient is assigned to either (Y) an initial arm or (Z) a continued arm based on the results of the interim analyses, followed by a final analysis at the end of the study.
2. Sequence-to-Sequence Adaptive Trial Design:
This design combines the traditional randomised trial sequence and a sequential block design. It consists of two phases, a simulation phase followed by a testing phase. Randomisation occurs in the simulation phase, and data are simulated according to the design parameters.
The results of the two phases are compared to identify their differences. The trial is then analysed in the testing phase using the final information from the simulation phase.
3. Platform Trial Design:
Platform trial designs represent an interesting and revolutionary alternative to traditional randomised clinical trials. Platform trial designs combine the advantages of both the linear and adaptive approaches. The term “platform” refers to a set of mutually supportive practices, technologies, or resources available to collaboratively develop new products or services.
It is often used in multimodal clinical research involving multiple modalities, devices, measurements, and scales. Platform trials combine the advantages of adaptive problems with platform trial design.
4. Clinical Trial Design Challenges:
Despite the many advantages of these innovative approaches, several challenges must be addressed before becoming effective. A large population is necessary to conduct adaptive trials.
Such trials are generally conducted on consecutive cohorts, which can take years to enrol. A limitation is the availability of patient populations with different severities and response rates in other settings. Further, they have a large scope in clinical trial design.
Adaptive and platform trials represent innovative approaches in clinical trial design that have the potential to revolutionise the field of medical research. Compared to traditional trial designs, these approaches offer increased flexibility, efficiency, and cost-effectiveness.
By incorporating adaptive elements, trials can be modified in response to accumulating data, leading to more informed decision-making and shorter trial durations. Organizations such as ClinTrek provide a framework for simultaneously evaluating multiple treatments and interventions, allowing for faster identification of effective therapies and personalised medicine approaches.