Most experts agree that clinical data standardization can improve research dissemination, increase data quality, facilitate data exchange and even accelerate regulatory approval. Developing and adhering to standards requires the concerted effort of multiple stakeholders including data experts, software engineers, contract research organizations (CROs), regulators and scientists.
Last week, eClinical technology expert Medrio and the data-driven CRO Bioforum announced a partnership to optimize clinical data standardization. The partnership will provide customers with access to Medrio and Bioforum assets to enhance clinical data management.
“We’re excited to launch this collaboration and confident that together we can help our life sciences clients improve efficiencies in all stages of clinical development — from study design and start-up through execution and submission,” said Amir Malka, co-founder and president of Bioforum, in a statement.
It’s often thought that the more data one has, the better. This is irrefutable for some indications such as cancer, where family history, lifestyle, tumor biology plus one’s genetic makeup, age and gender can affect patient outcomes. Now, there are many more ways to collect patient data including patient-reported outcomes through wearable devices. These disparate forms of data can pose a challenge for analysts and study coordinators who are required to organize these results into specific formats for regulatory approval.
The different ways data is reported poses another challenge for sponsors. In a 2013 workshop on sharing clinical data, founder and president emeritus of the Clinical Data Interchange Standards Consortium (CDISC) Dr. Rebecca Daniels Kush pointed out that reporting the gender of study participants differs between studies. Because these designations are largely arbitrary (e.g. 1 and 2, M and F, 0 and 1, etc.), data must be analyzed by hand to confirm the proportion of males to females in a study. Not only does this require significant time and money, but information can be lost when information is gathered in different ways.
With all of these disparate forms of data, there is an urgent need to change the way clinical data is handled.
“Reducing variation and standardizing clinical data is central to improving its quality and usability,” said Mike Novotny, Founder and Chief Executive Officer of Medrio.
Under this new partnership, Medrio customers will have access to Bioforum’s data standardization platform which is designed to collect data throughout a study, then format it to be compliant with US regulations and adherent to CDISC standards. The platform, known as JET-Convert, is intended to help accelerate the decision-making process and enable information exchange between trial stakeholders.
Ultimately, standardizing data will go a long way to improving clinical trials. However, sponsors should be mindful that standardization does not ensure data quality, and at the same time, high-quality, well-organized data alone will not be enough to affect change.
“Data obviously is very prevalent in our industry and becoming much more accessible to all of the different constituents within the industry,” told Dr. Michael Kleppinger, executive vice president of clinical market development of Syneos Health, to Xtalks at DIA Global Annual Conference 2019. “It’s all about how we convert that data to actionable intelligence.”
In other words, optimizing clinical data standardization isn’t the only solution to improving clinical trials — but it’s a start.