Trends in Trial Outcomes
(AdisInsight Database 2014–July 2024)
Trend Analysis of Trials with Positive Outcomes
Positive results from clinical trials are a crucial indicator that a new treatment or procedure is both effective and safe, offering potential improvements for individuals affected by various diseases or conditions. A thorough analysis of positive outcomes from completed and prematurely discontinued trials (2014–July 2024) in the AdisInsight database shows that 2019 had the highest number of trials reaching completion due to positive results. This year marked a significant milestone in clinical research, with numerous therapies and interventions demonstrating promise and contributing to advancements in treatment options across various therapeutic areas. The success of these trials highlights the critical need for continued investment in research and development to address unmet medical needs. For example, the ImmunoCobiVem trial, a Phase II study of cobimetinib plus vemurafenib for patients with unresectable or metastatic BRAF V600 mutant melanoma, and the CAPTIVATE trial, a Phase II study of the combination of ibrutinib plus venetoclax in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma patients, were completed based on positive trial outcomes.
Number of trials with positive outcomes for completed and prematurely discontinued trials (2014-July 2024)
Fig 12: Trials with positive outcomes from 2014-July 2024
Trend Analysis of Trials with Negative Outcomes
A negative result in a clinical trial occurs when the intervention being tested shows no effect or when one treatment is not superior to another. These outcomes can arise from various factors, such as flaws in trial design, poor execution, or an insufficient sample size (underpowered trials). Although negative results may seem like failures, they hold significant value for patients, researchers, and the broader scientific community. They can improve patient care by helping healthcare providers avoid unnecessary treatments or interventions. Negative results also promote transparency in clinical research, as publishing such outcomes ensures accountability and provides a complete understanding of treatment efficacy. Furthermore, they contribute to scientific progress by offering insights into the limitations of certain interventions, thus enhancing the overall understanding of diseases. An analysis of clinical trial outcomes from the AdisInsight database (2014–July 2024) shows that 2019 had the highest number of trials completed with negative results. Additionally, 2020 saw the highest number of trials discontinued, reflecting the challenges faced in clinical research during that year. Despite these setbacks, negative results are essential in refining research practices and guiding future treatment strategies. Notable examples include the EVOLUTION RMS2 trial, a Phase III study comparing evobrutinib with teriflunomide in participants with relapsing multiple sclerosis to assess efficacy and safety, and the Prevent trial, a Phase III study evaluating the safety and efficacy of ALVR105 (Viralym-M) compared to placebo for the prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV infections, both of which were discontinued early due to negative outcomes.
Number of trials with negative outcomes for completed and prematurely discontinued trials (2014-July 2024)
Fig 13: Trials with negative outcomes from 2014-July 2024