• The Time is Right to Disrupt Clinical Cancer Trials and Accelerate Innovation

    Clinical Research News | As we prepare for a new decade, marked at its start by the astonishingly speedy development of a vaccine for COVID-19, clinical trial sponsors have the opportunity to disrupt the traditional drug development process like never before by using real-world data.

    Aug 18, 2021

  • Predicting Patient Response In COVID-19 Drug Trials

    Clinical Research News | Based on cellular-level insights from previous COVID-19 clinical trials, mathematical modelers at the University of Waterloo (Ontario) have simulated how the body deals with the virus as a starting point for predicting how patients will respond to new experimental vaccines and treatments—including those targeting variants of concern. While this is a generic model meant to reflect an “average human being,” it can be customized to more precisely forecast drug effectiveness in individuals according to variables such as their gender, age, and comorbid conditions.

    Aug 16, 2021

  • An Application Now Rests with the FDA: How to Manage the Review Process

    Clinical Research News | What is happening inside the FDA and the Center for Drug Evaluation and Research (CDER) statisticians in the review of the drug/device application? We look at what data are analyzed, the integrated review process, and labeling and post-approval evaluation.

    Aug 13, 2021

  • Ovarian Cancer Chip Model Reveals Drug Repurposing Opportunities

    Clinical Research News | A novel organ-on-a-chip model of ovarian cancer has been used to showcase the sinister activities of tumors, including use of circulating platelets to fuel their growth and undermine treatment with chemotherapeutic drugs. The model also demonstrated the potential of an anti-platelet drug, currently in clinical trials for a different condition: to fight back.

    Aug 11, 2021

  • What You Don’t know, Will Hurt You: Overcoming “Missingness” in Healthcare Data

    Clinical Research News | Most data sets—especially in healthcare—are missing data and, therefore, may not sufficiently representative to support the broader conclusions being drawn about groups of patients. Missing values is a problem that data scientists refer to as “missingness.” Even if data isn’t specifically missing, often the quality of the data is so poor that it is unusable and functionally considered missing. This missingness often leads directly to poor analytics outcomes.

    Aug 6, 2021

  • Follow the Money: Clinical Trial Platforms, Improving Diversity in Trials

    Clinical Research News | Novartis and PCORI both invest in eliminating racial disparity in clinical research, 4G gets a big growth equity investment for randomization and trial supply management, ObvioHealth seeks to integrate the EHR for clinical trial design, and more.

    Aug 5, 2021

  • Parexel Acquisition, Medable Expands to Europe, NSF Funds for RWE Outcomes

    Clinical Research News | Parexel acquired by private equity business, American Heart Association seeks genomic diversity, partnerships for Flywheel and HealthMyne as well as Marken and THREAD.

    Aug 3, 2021