Applied Clinical Trials-05-01-2020

The need for statisticians, mathematicians, and computer and data scientists to collaborate on modern methods for “substantial evidence” in drug development is critical.

Leveraging approaches in RBQM to enable effective corrective and preventive action processes.

Implementing centralized risk-based monitoring can help meet strict GCP requirements for study conduct, oversight, and recording.

Physician scientist-turned entrepreneur discusses the adoption of remote, decentralized, and virtual trials and the likely new research landscape post-pandemic.

Regulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic.

With hundreds of trials for potential coronavirus drugs in the works, concerns swirl around the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

The agency has taken the lead in orchestrating a series of meetings of the International Coalition of Medicines Regulatory Authorities to help share information and collaborate in speeding COVID-19 drug and vaccine development and approval.

A compilation of recent notable news developments that pertain to the clinical trials industry.

A look at the effectiveness of one training and educational program in helping to initiate rollout of risk-based quality management practices.

Click the title above to open the Applied Clinical Trials May 2020 issue in an interactive PDF format.

With the bevy of coronavirus-specific information, databases and trackers, registries, and other tools out there at the moment, the challenge in store is integrating these resources to help in both clinical care response and informing drug intervention in real-time.