Something old, something new: the data that will reshape clinical trials

The dramatic availability of new data sources along with the opportunity to leverage existing data pools, is radically changing the way we think about clinical trials, writes Mike Capone, chief operating officer of Medidata, the provider of cloud-based solutions for clinical research, in an Expert View piece.

With the right preparation, historical trial data and genomic data will transform clinical trials, resulting in sponsors gaining insight earlier, making trials safer, and more closely achieving their therapeutic goals.

The key to the success of this transformation is understanding how to use this data for new insights without being overwhelmed by streams of new data.

Transformational change in the industry will come from both old data sources and new.

Lost opportunities and decisions made in the dark

Let’s start with the old. Thousands of clinical trials have been conducted over the years. Many of these trials result in published reports in peer-reviewed journals. This is an important resource. As sponsors develop new products, especially in the early stages, they consult published data in their therapeutic area to draw insight for their own development program. Yet we are missing a huge opportunity because data is not typically published on unsuccessful clinical trials, which means we do not learn from what has not worked in the past.