Early termination of pivotal trials in Alzheimer's disease-Preserving optimal value for participants and science.

ABSTRACT

Participants in Alzheimer's disease late-phase clinical trials are frequently confronted with a situation of early termination. We discuss measures to protect the perceived value of study participation and to maximize the scientific value under such circumstances. A communication strategy should ensure that trial participants maintain a positive relationship with the research team and have their informational needs optimally met. Measures to maximize the scientific value may include data/sample sharing, strategies for personalized medicine, as well as scientific follow-up. Critical for the success of such a concept are networks of excellence, extending models of existing initiatives like Global Alzheimer's Platform Foundation Network (GAP-Net). These networks could fundamentally strengthen the role of clinical investigators if they decide on their involvement in trials based upon their estimation of the scientific value and benefit for the participants, actively contribute to scientific analyses, and mediate optimal communication among the relevant trial stakeholders.