• DIA 2023 Topic: The Industry-Wide Definition for RBQM

    Clinical Research News | At an RBQM expert dinner hosted by CluePoints and the Tufts Center for the Study of Drug Development’s (CSDD), Ken Getz shared the results of a global industry-wide survey on RBQM adoption and attitudes. The survey was conducted by Ken and his team at the Tufts CSDD in collaboration with CluePoints and Price Waterhouse Cooper.

    Oct 6, 2023

  • NCI To Conduct Massive Study To Evaluate Multi-Cancer Detection Assays

    Clinical Research News | The importance of data has become apparent to everybody in recent years. We can now interrogate massive datasets to add value to clinical trials and utilize technology more efficiently to speed up time to market.

    Oct 3, 2023

  • Medidata Launches Diversity Program, HHS Extends Partnership to Develop Monoclonal Antibodies, Flatiron Renews FDA Collab

    Clinical Research News | Flatiron Health renewed its collaboration with the Oncology Center of Excellence (OCE) of the United States Food and Drug Administration (FDA) to jointly develop and implement specific research projects; Medidata launched a program to improve diversity, equity, and inclusion in clinical trials; The U.S. Department of Health and Human Services (HHS) announced new details of its agreement with Regeneron to extend its public-private partnership to develop life-saving monoclonal antibodies as part of Project NextGen enhancing our preparedness for COVID-19 strains and variants; and more.

    Sep 28, 2023

  • Follow the Money: NCI Awards Grant For Prostate Cancer Treatment Study, Recruiting Participants For Immunotherapy Drug Trials

    Clinical Research News | The Icahn School of Medicine at Mount Sinai nets a grant to identify the best prostate cancer treatment for people with HIV; EverImmune will conduct a phase I/II clinical trial for its drug candidate Oncobax AK in patients undergoing immunotherapy; NIH establishes the Multi-Omics for Health and Disease Consortium to advance the generation and analysis of “multi-omic” data for human health research; more.

    Sep 27, 2023

  • Proteomics-Based Assays To Enable Precision Medicine For Ovarian Cancer

    Clinical Research News | Over 900 genes have been implicated in the resistance of tumors to platinum-based chemotherapy that map to many different cellular pathways, thwarting efforts to identify a biomarker to predict refractoriness.

    Sep 26, 2023

  • Adopting New Patient-Centric Payment Solutions for Whole-Industry Benefits

    Clinical Research News | The clinical trial landscape has a long-acknowledged problem – a lack of participant diversity. Most clinical trial participants are from higher-income households, white and male.

    Sep 22, 2023

  • COVID Vaccine Developers May Want To Pivot To Symptom Prevention

    Clinical Research News | Vaccine developers may want to consider designing formulations intended to prevent symptoms rather than infection, which the COVID-19 pandemic has demonstrated can be hard to do with any long-lasting effect.

    Sep 19, 2023

  • City of Hope’s Harmonized, Findable, Accessible Precision Medicine Data Platform

    Clinical Research News | INNOVATIVE PRACTICES AWARDS—When City of Hope wanted to better use its primary and secondary clinical research data and harmonize files on more than 700,000 patients so they were findable and accessible, the hospital built a highly scalable, compliant cloud-based platform.

    Sep 14, 2023

  • Changes Afoot In The Regulatory Landscape For Companion Diagnostics

    Clinical Research News | The U.S. Food and Drug Administration (FDA) has been making moves signaling its intention to better align the regulatory framework for companion diagnostics (CDx) to what is happening in real-world clinical practice.

    Sep 13, 2023

  • Study Finds Breast Cancer Spreads During Sleep, Highlights Role Of Hormones

    Clinical Research News | The recent discovery that the metastatic spread of breast cancer accelerates during sleep sparked a lively conversation at last month’s Next Generation Dx Summit about new paths of exploration for thwarting a deadly pan-cancer process claiming 12 lives worldwide every minute.

    Sep 12, 2023

  • Automated Speech Analysis: A Promising New Avenue For Patient Monitoring In Alzheimer’s Trials

    Clinical Research News | As experimental drugs to treat Alzheimer’s disease increasingly target the disease’s very initial stages, monitoring the impact of novel treatments on cognition has become a complex undertaking for trial sponsors.

    Sep 8, 2023

  • The Clinical Realities Of Chronic Wounds With Dr. Caroline Fife

    Clinical Research News | When Dr. Caroline Fife stepped into her first clinical trial in 1997, she was met with a waiting room packed with patients. Despite the large number of potential participants, none of them were considered healthy enough for the clinical trial. That was when she realized something was very wrong.

    Sep 5, 2023

  • Phastar Appoints New CEO, New Global Research Centers, New Partnerships Announced, More

    Clinical Research News | Phastar appoints a new CEO amid organization changes and growth plans; Celltrion opens a Global R&D Center in South Korea for research capabilities and technologies spanning all areas of biopharmaceutics; Clario and AliveCor, Standigm and Nashville Biosciences, C2i Genomics and the Tel Aviv Sourasky Medical Center (Ichilov) announce partnerships; more.

    Aug 31, 2023

  • Massive Acquisition Of Obesity Drug Developer, Clinical Programs For Rare Genetic Disease, Clinical Translation Of Gene Therapies, More

    Clinical Research News | Novo Nordisk acquires Inversago Pharma and the development of an appetite regulator; ADARx Pharmaceuticals will advance clinical programs on a rare genetic disease with new funding; Kriya Therapeutics plans to use Series C funding for clinical translation of gene therapies; more.

    Aug 30, 2023

  • AI-Powered inClinico Aims To Solve The Phase 2-To-3 Transition Problem

    Clinical Research News | Insilico Medicine recently broke the news that one of its platforms, powered by artificial intelligence (AI), succeeded in predicting the outcomes of several phase 2 clinical trials.

    Aug 24, 2023

  • Novel Biomarker Tracks Tightly With Tau Tangles In Alzheimer’s Disease

    Clinical Research News | Researchers in the U.S. and Sweden have identified a biomarker (MTBR-tau243) for Alzheimer’s disease that tracks with the amount of damaging tau tangles in the brain and, when combined with a specific phosphorylated tau species (p-tau205), is nearly as predictive of cognitive function as tau-positron emission tomography (tau-PET) imaging.

    Aug 23, 2023

  • ‘Swarm Learning’ Approach To Improving Care Of Colorectal Cancer Patients

    Clinical Research News | Over the next three years, researchers from across five universities in Germany will be using “swarm learning” on retrospective tissue samples to gain insights on the tumor biology of hereditary colorectal cancer (CRC).

    Aug 22, 2023

  • Toward Optimizing Site Feasibility Assessment For Clinical Trials

    Clinical Research News | Selecting appropriate sites is one of the most crucial factors for determining successful completion of a clinical trial. It is important to ensure that potential trial sites have the capability to meet the protocol requirements and the capacity to deliver the study objectives in a safe and efficient manner.

    Aug 18, 2023

  • Neurosurgeons In Czech Republic Test Writing Capabilities Of ChatGPT

    Clinical Research News | Researchers in the Czech Republic succeeded in using ChatGPT (Chat Generative Pre-trained Transformer) to produce a convincing scientific article in only one hour with no special human training—a feat intended to point out the current capabilities of large language models (LLMs).

    Aug 16, 2023

  • AI Bringing Major Change To The Way Studies Get Conducted

    Clinical Research News | Clinical research stakeholders, most especially study sponsors, are now firmly onboard with the idea of using artificial intelligence (AI) to improve the conduct of clinical trials.

    Aug 15, 2023