Clinical trials data: sharing success

Clinical trials data: sharing success

Andrew Jack’s recent article in the Financial Times touches on a hot debate across the pharmaceutical industry: should European and US drug companies be required to share clinical trials data with both researchers and competitors? Whilst many pharmaceutical and biotech firms are resisting regulators’ attempts to improve transparency, I would rather concentrate on how these companies can benefit from increased data sharing.

It is important to realize that the real world population is rarely reflected in the selected population of a single clinical trial dataset. Combining and mining multiple datasets has the ability to produce a more holistic view, which is the standard both patients and regulators expect therapies to be measured against.

Today’s pharmaceutical companies are increasingly working with one another in pre-competitive preclinical research efforts. This is in recognition that no one company has a monopoly on scientific insight and that millions of shareholder dollars are spent in repeating research and development (R&D) work already performed by others. Imagine a scenario, therefore, where all clinical data is anonymized and made accessible to both researchers and competitors. Competitive advantage, as with preclinical, would then stem from the best, innovative use of the data.

This better use of data is imperative as we approach an era of personalized medicine, where identification of subsets of the real world population are vital in identifying those who will respond positively, negatively or not at all to therapies. UK Government initiatives such as the 100,000 Genome Project and Clinical Practice Research Datalink (CPRD) promote the benefits of combining large datasets of real world data to predict outcomes and provide a foundation for the development of precision medicines.

Pharmaceutical companies need to embrace the challenge of using combined datasets to uncover insights they didn’t previously have. This has the potential to benefit both the competing companies producing drugs and patients who will have improved outcomes.