About this paper
Consensus is building around the idea that greater access to patient-level clinical data is a good thing – good for science, business and humanity. From a business perspective, pooling data can significantly reduce the cost of drug development while improving the efficiency of clinical trials. It can also lower clinical trial costs by reducing the number of patients needed for new studies. But data sharing and transparency raises new issues and brings a host of new questions, benefits and risks. For example, unless appropriate safeguards are in place, open access to clinical trial data could compromise patient privacy, enable faulty science, and be a resource-intensive burden for trial sponsors and data stewards. This paper discusses different approaches to successfully implementing clinical trial data transparency while mitigating these risks.