Wednesday, May 27, 2015

Show Me Your Data: How Transparency is Driving Drug Development

By: Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.

The pharmaceutical industry is in an era of openness and collaboration with the transparency of clinical trial data at the forefront. At Partnerships in Clinical Trials last month, several presentations addressed the data sharing movement.

Inefficiencies in clinical research

There is so much data out there; the struggle is getting more eyes on it. We sit around and complain about how much drug development costs, yet we’re not using what’s already available. We only ever analyze 14 percent of the data from clinical trials and almost always end up starting from scratch with each new study. Throwing away this incredible resource is both expensive and time-consuming. Why not make use of what someone else has already done?

Who benefits from data sharing?

There is a challenge around analytics, as each stakeholder finds different data meaningful. Those who share their data aren’t necessarily the ones who benefit. If a pharmaceutical company shares their data, it’s most often the researchers who can swoop in and do something with it. Being able to combine data from multiple sources enables them to draw new connections. So, who owns the data? It’s curated by sponsors, but is raw data a pubic asset? Sharing the results from clinical trials can benefit the patients who participated. This can help the experience come full circle for them when they can see what resulted from their contribution to the study. Francis S. Collins, NIH Director said, “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health.” After all, without patients we wouldn’t have any data.

Should everyone be granted access to clinical trials data?

It seems as though the thought of data being made public is uncomfortable for many people. A large concern is the lack of control. There’s ambiguity around what will be done with that data, and there are serious consequences if data are misinterpreted. When it gets into the hands of the public, it can get very confusing. There will be enormous amounts of noise and contamination, so we must help people understand what data are usable and worthwhile. The industry may consider requiring that the person downloading the data sets show their plan for analysis, so it’s not just a data mining exercise.
                            
Learning from failures

Clinical trials are the most expensive experiment in the world. Half of them fail, and we never release the trial information. Those failed molecules are sitting on the shelf gathering dust. For a molecule that worked in only a quarter of patients, instead of thinking of it as a failed trial, we should be paying more attention to the fact that it was spectacularly effective in that small subset of patients. Sometimes, all it takes is one part of a failed molecule to be reinvented with great results. This wealth of data can help companies to fail and succeed faster.

The drug development landscape as a whole can benefit from data sharing, as there are many downstream benefits. Yet, there are still things we’re figuring out with data sharing. For example, what’s the metric for success – the number of trials we get online? The number of times the data is accessed? Is there value in having these things done in the first place? Time will tell as the practice of data sharing becomes more common, and we’ll realize the value and utility in being more transparent with clinical trial data.


About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina served as the guest blogger covering Partnerships in Clinical Trials 2015. 




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