TransCelerate Moves Forward With Electronic Label Initiative

By Ed Miseta, Chief Editor, Clinical Leader

TransCelerate BioPharma has announced the launch of its electronic labels (e-labels) Initiative, which will work to remove barriers to adoption of e-Labels and facilitate implementation at interested sponsor companies.  The Initiative will also work to enhance label usefulness for patients, while providing more consistent labeling approaches for sites.  e-Labeling solutions  may reduce  labeling timelines in the investigational supply chain, and in the long-term create cost efficiencies for  biopharmaceutical  companies.  

“There are two initiatives that TransCelerate has just approved as full workstreams, meaning the board has approved them,” says Craig Lipset, head of clinical innovation at Pfizer and executive sponsor of the TransCelerate e-Labels Initiative. “These had previously been classified as exploratory workstreams, meaning members will contribute subject matter experts to figure out what the scope of a project would look like, and the end result we hope to achieve. When their work is done, we bring it back to the board with a timeline, a budget and the expected deliverables. The board then decides whether or not to approve it as a full workstream. The two efforts just approved involve e-labels and placebo/standard of care.”

From Paper To Digital

eLabels have been an exploratory Initiative for some time, and started off with a lot of sponsors thinking about innovative ways to use existing technologies. Many organizations have already been developing pilots or other initiatives to move content from a label onto a mobile device to be used in clinical trials. This effort would allow sponsors to update content faster than could be done on a physical label.

 “Most of your clinical trial medicines come with a booklet label- similar to a package insert,” notes Lipset. “A small font is used to get all of the information on a small sheet, and that makes it hard to read. Also, regulations require the content be presented in the languages of the countries where the trial is being conducted. But at the same time, today there are so many new and interesting ways to render content, including multimedia. Labels are also affected not only by the cost of producing them, but by changes to the content that can occur during the trial.   For example if a typo is found during the trial in one of the 40 different languages included in the labels or if the trial design has a planned change (adaptive trial).  When that happens, sponsors have to gather up any product that has been shipped and from the warehouse, change the labels, and send it back out. That creates a large time and cost element for sponsors to deal with.”

There is also a comprehension element. If multimedia and other methods can be used to communicate information to stakeholders (patients, investigators, pharmacists, clinicians, etc.), pharma can better insure that everyone is using the medicines correctly during clinical trials. Today, it is hard to know how many patients even bother to open the information contained with medicines, or how well they are able to understand it. If patients instead are using a technology to access the information, sponsors can determine who is reading it, and what sections they might find confusing.

Engage Regulators Early

Lipset points out that for many companies, the barrier was not really around technology, it was around engaging with regulators. To assist with those issues, TransCelerate is collaborating with various regulatory agencies on a global basis to help identify the pathways for the industry to move to get from paper to electronic labels. In this way, the effort will start to resemble other TransCelerate efforts, such as risk-based monitoring, where the group produced white papers, engaged with regulators to build comfort and confidence, and continued to move forward with Initiatives.

So how will this effort play out for consumers? Lipset notes there could be a hybrid approach, but to really get the most out of it, the paper label should be eliminated altogether. Instead of paper there could be technology, such as a QR code, that when scanned with a mobile device provides information on the product. The information could be updated in real time as new data becomes available.

On the regulatory side, decisions would have to be made regarding whether the technology is appropriate, whether there is sufficient confidence around the controls (i.e. to ensure the patient is seeing the right version of the information), and the best practices and expectations for companies looking to deploy the technology. Only then will regulators have confidence that the label information being used is correct and current. From the initial engagements with regulators, it appears there is an appetite and enthusiasm for the effort, as long as the industry can figure out the path on which to move from the current state to the vision of a paperless package.

Lipset notes the effort is currently focused on clinical trials, but could eventually be extended to commercial medicines as well.