By Ed Miseta, Chief Editor, Clinical Leader
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TransCelerate BioPharma has been working to improve clinical trials across the industry. The non-profit organization is focused on advancing innovation in R&D while identifying and solving common R&D challenges. The goal is to improve patient safety and deliver higher quality medicines to patients.
DrugDev is hoping to play a role in improving clinical trials as well, via a family of technology solutions that bring together investigators, sponsors, and CROs, enabling them to perform more clinical trials. Over the past two years, the company has acquired CFS Clinical for investigator payments and the TrialNetworks study platform for optimizing clinical operations. It also serves as the third-party host of the Investigator Databank, a colaboration for site and investigator data sharing by Pfizer, Janssen, Lilly, Novartis and Merck.
Now, TransCelerate and DrugDev will work together to advance clinical trials. TransCelerate announced it has selected DrugDev to develop and host the Investigator Registry. Along with TransCelerate’s shared Investigator Platform, the Registry is expected to streamline some of the more inefficient clinical trial processes. TransCelerate member companies will now be able to pool investigator data together into a centralized, cloud-based resource using DrugDev’s Golden number. The Golden Number is a unique identifier that allows pharma companies to create a single source for all the data collected, and produce a single index number for each investigator.
DrugDev was certainly selected because of its history with the Investigator Databank which has also shown significant buy-in from the investigators as well. TransCelerate believes the collaboration is a significant step forward in the continuing evolution of trials and will ultimately make investigator selection easier for sponsors and CROs, while making the entire trial process more efficient. The ability of sponsors to better match investigators to trials will drive improved performance, including faster start-up times, more timely patient recruitment, increased patient retention, enhanced operational efficiencies, and fewer non-performing or under-performing sites.
The Investigator Registry is expected to provide greater opportunities for investigators as well, making them known to TransCelerate member companies. At the same time, making their site profile information available to the registry will reduce the number site information requests they receive, allowing them to focus more time on clinical activities and services. It should also help to bring more recognition to investigators, which DrugDev CEO Ibs Mahmood believes is long overdue.
“The investigators are the foundation on which clinical trials are built,” he says. “I can’t imagine a world, anytime soon, where anything other than a small minority of trials will be run without involving an investigator. In trials we are administering an experimental chemical to patients, so it is something that absolutely needs appropriate medical oversight. So investigators are very much needed in the conduct of trials.”
Unfortunately the process of finding and engaging with investigators is not handled with the care it deserves. Sponsors and CROs might consider investigators as an afterthought, connecting with them at the last minute and only when deemed necessary. With all of the talk in pharma about partnering, they are one group that more often than not is treated as service providers. While not intentional, pharma can also make investigators feel unimportant by paying them late and sporadically – for example in 60 days or in 90 days. Any employee subject to those terms would likely not be too satisfied. As a result, many investigators are leaving the industry that is in need of their services.
“At the same time, the industry is learning from what it has done in the past and genuinely trying to do things in a different way,” says Mahmood. “Central to that will be reengaging investigators, and that makes having one source with which to connect the industry even more vital. As the industry continues to work to make trials more efficient, this is something that needed to be done. The only way we will be able to stop the slide of clinical trial inefficiency is if we have standardization through technology. In the future, I believe the companies that best use technology to focus on clinical excellence will be the winners.”
At this time the Investigator Registry can certainly be considered the inspiration for the Investigator Databank. TransCelerate obviously exists to drive efficiency in clinical trials through the adoption of standardized processes. If TransCelerate produces a paper on a topic, and enough members start doing it, it may become the norm in the industry. The Investigator Registry is getting a great kick start through this adoption. As its adoption by members becomes the norm, I think we can expect it to be a win for both sponsors as well as CROs.