Historically, most interventional research has been conducted using well-established designs such as the randomised controlled trial. In recent years however, frustrations with the speed and ever-growing financial burden of such studies has led researchers to more often consider the use of innovative designs.
What are innovative designs?
The term innovative design encompasses a wide range of methodologies, each of which brings its own potential advantages over conventional research methods. Nonetheless, they all share the common goal of providing increased efficiency in some form (e.g. in terms of reducing financial costs), with many carrying the significant benefit of allowing multiple questions to be answered in a single study. Examples of innovative designs that have now been successfully used in practice include:
- Adaptive designs: employ techniques that can help overcome statistical and ethical issues that may be faced with a traditional design, such as where there is a need to reassess the sample size during the study, or where eligibility criteria may need to be updated. Our previous RDS blog on adaptation discusses in detail why these methods are being more regularly used today
- Seamless cross-phase designs: minimise ‘white space’ i.e.the time between data analysis in one phase of research, and recruitment of patients to the next. Simultaneously, they provide the flexibility to evaluate other important questions like dose-finding or sub-population selection, ultimately helping define the safety and utility of several interventions
- Master protocols: comprise a single, overarching design developed to evaluate multiple questions efficiently with standardisation of procedures across evaluations. Important examples include basket and umbrella trials
- Basket trials evaluate a therapy in multiple diseases that share common traits (defined, for example, by molecular mutations)
- Umbrella trials evaluate multiple therapies for a single disease stratified into several sub-groups
While master protocols have been generally used in oncology settings, several recent discussions have highlighted their potential value in other areas, such as immune-mediated inflammatory diseases.
How the RDS can help
Effectively delivering an innovatively designed trial can be challenging. RDS is available to help your project in a variety of ways. You should:
- Get in touch with us early in your research process: innovative designs can be more difficult to plan than a conventional study. For example, you might need to conduct PPIE work to make a compelling case for the innovative approach
- Assess and get guidance on the innovative approach: innovative designs aren’t always the right choice and we recommend discussing this with your adviser, a statistician, and an ethics expert
- Be aware of any regulatory considerations at play: anticipate potentially needing to liaise with HTA bodies and regulators, such as the Health Research Authority and the Medicines and Healthcare products Regulatory Agency
- Construct a TSC/DMEC/advisory group with the required expertise: the RDS can use our network of contacts to help with this.
Want to know more?
Over the coming year, RDS London and RDS North East and Cumbria are working together with all our regional offices to develop our support offering in this space - stay tuned for more updates.
In the meantime, if you would like support to decide whether an innovative design is right for your research application, please contact your local RDS.