Explore Enrichment Factors

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Background. Recently we completed a project and explored the enrichment factors that can be used to increase the ability of the clinical trial to demonstrate the treatment effect. The analyzed data is from a randomized, double blind, placebo-controlled Phase 3 clinical trial conducted in multinational centers.

Purposes and Assumptions.  Using the analysis data from this study, a series of analyses on patients’ baseline measurements in the ITT population were performed with two purposes:  1) to identify a group of patients (enriching group) who might have greater benefit from the treatment; or 2) a large placebo responders.  In terms of the disease characteristics, demographic factors, such as age, gender, and age-gender interaction were first assumed to be potential enriching factors. Meanwhile, the medical history, disease severity at baseline and concomitant drug usage as well as their interactions were also assumed to have influence on the drug effects. Read more

New Breakthroughs Create New Cancer Research Endpoints

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In December 2018 the FDA released new guidelines for clinical trials of cancer drugs and biologics. Such endpoints serve different purposes at different points in time during the trial. During early trials the focus is on efficacy and safety. Later on, trials select endpoints for clinical benefits like improved survival and symptom relief.

 

For cancer patients, the survival rate is considered the optimum endpoint all other things being equal. Tumor assessment and symptom assessment are two other common endpoint categories.

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Phase3.bio Shows How FDA Deliberations Impact Pending Drug Approvals

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New Web Destination Provides Detailed Analysis of the FDA’s Deliberations on Specific Treatments

PRINCETON, New Jersey, August 16, 2018 — Phase3.bio, a new free web service that covers FDA deliberations in depth, has just launched.

The site features expert biostatistical analysis from highly skilled PhDs, scrutiny of meeting minutes, insight on voting patterns, exploration of FDA rebuttals, in-depth study analysis, and details on discussions and meeting minutes.

The FDA review team’s deliberative process for drug evaluation can be hard to follow, and important data points challenging to isolate. Phase3.bio puts the process into perspective so directors of research at drug development companies can better understand the implications for their own pending drug approvals.

Phase3.bio synthesizes analysis into a case report, including a video presentation narrated by a drug development expert that summarizes the documentation. In addition to the video, the material is available in downloadable PDF and web versions that include detailed links and citations. Phase3.bio’s first case report is on Blincyto (blinatumomab), which was granted accelerated approval as a treatment for acute lymphoblastic leukemia patients in full remission.

“We recently surveyed people who closely follow FDA advisory meetings on new drug approvals,” says Jeffrey Zhang, Principal Biostatistician and Managing Partner at Princeton Pharmatech, which sponsored the launch of Phase3.bio. “They usually have to visit several websites to find treatments similar to their own, then pour over reports and watch videos. Phase3.bio takes that legwork out of the equation. With shrewd and incisive analysis from some of the top names in biostatistical data analysis, I think that Phase3.bio will be an indispensable tool for the entire pharmaceutical industry.”

All the resources on the site are free after a quick registration. Visit Phase3.bio, then sign up and start utilizing the resources, including our first case report on Blincyto (blinatumomab), which was a pivotal win for Amgen.

Press Contact:
Jeffrey Zhang, Ph.D.
Principal Statistician/Managing Director
Main: 609-681-5074 ext 102
jeffrey.zhang@princetonpharmatech.com