Research Note: Adaptive trials

摘要

The number of clinical trials published each year shows no sign of reaching a plateau,’ despite the cost of conducting a clinical trial rising five-fold over the past decade.* Randomised clinical trials (RCTs) can have a profound and immediate impact on health policy and clinical practice, but while activity and quality have increased, only around half of all trials are published.’ Even when RCT evidence exists, there may be a failure to adopt this as best practice if the results are considered non-applicable to the specific patient at hand, or where there is mismanagement of commercial and academic interests,’ or other biases in the design, management, or reporting.’ Clinicians are often faced with the need to make treatment decisions across a range of comorbidities, whereas evidence from RCTs is predominantly presented for a single medical indication and frequently assumes homogeneity in participant responses. A one-size-fits-all approach to clinical trials is not in harmony with the heterogeneity and complexity of modern diseases. While the pipeline of new treatments is ever-increasing, the capacity to formally evaluate new treatments in RCTs is diminishing, due to the large inherent costs, overburdened healthcare system and low participation rates.° Almost half of publicly funded trials do not meet recruitment targets,° increasing the costs and the risk of inconclusive results.