New program to expedite clinical trials through data sharing

“In the pharmaceutical industry, there is a systemic challenge in finding faster ways and the proper number of patients to launch a clinical trial or study​,” William S. Dalton, M.D., Ph.D., founder and CEO of M2Gen, told us. “This is an even bigger challenge when the target population that will most likely benefit from a new therapy is identified based on molecular characteristics that are uniquely expressed in small subsets of patients​.”

To help combat these issues, M2Gen, an informatics solution company, and the Oncology Research Information Exchange Network (ORIEN), a research partnership among North America's cancer centers, announced the ORIEN Avatar Research Program to advance precision medicines for cancer patients.

“ORIEN Avatar is focused on anticipating patient need, especially for those patients who are likely to need access to novel cancer treatments through clinical trials​,” said Dalton.

The new program will specifically focus on expanding and accelerating targeted trials for advanced stage cancers and high-risk patients by proactively studying data to identify the clinical trials that may benefit them.

“This is accomplished by understanding the clinical and molecular characteristics of each patient in the ORIEN database​,” explained Dalton.

These patients are then categorized into communities, which become the individual patient’s “Avatar.”

According to Dalton, these communities will help the researchers learn more about each patient’s needs in order to create evidence-based approaches to help meet those needs, such as matching him or her to clinical trials. 

“As we learn from the patient’s Avatar, we believe we can begin to predict need which allows us to anticipate and create options before the need manifests​,” added Dalton. “ORIEN Avatar is grounded in the belief that sharing data across multiple centers and multiple pharmaceutical companies will ultimately lead to new discoveries and create more options, and ultimately better outcomes for patients​.”

The program is constructed as a subscription service for partners, so it can be scaled to include any number of companies. M2Gen, who will manage the collaboration, has announced that Celgene Corporation will be the industry's founding member.

“By offering a large database of de-identified patient information to its partners, ORIEN Avatar will help pharmaceutical companies accelerate the process for identifying patient populations that can be proactively screened for clinical trials​,” said Dalton. “By being proactive and using the shared data, physicians and patients will have clinical trial options identified before the patient actually needs the trial​.”