• Experts Say Surrogate Endpoints Need More Regulatory Oversight

    Clinical Research News | “The benefits of using surrogate endpoints in drug trials are often outweighed by the harms of not knowing in a timely manner whether a new drug is effective in improving patient-relevant outcomes,” according to Huseyin Naci, associate professor of health policy at the London School of Economics and Political Science. Drugs approved based on surrogate endpoints—indirect measures for predicting outcomes such as laboratory values and radiographic images or, in oncology, response rates and disease-free survival—are sometimes later found to be ineffective or harmful.

    Oct 4, 2021
  • The Case For Considering Sex And Gender In Clinical Studies

    Clinical Research News | Researchers in Europe have found that most COVID-19 clinical trials to date have paid scant attention to the impact of sex and gender on the efficacy of pharmacological interventions—even after it became clear that those variables could have a striking effect on the outcomes of infected individuals. The findings could help make the case for “more and clearer regulations” around sex- and gender-sensitive analysis of study results.

    Sep 27, 2021
  • Clinical Trial Trends: 18 Months of Faster Tech Adoption, Real World Data, Increased Collaboration

    Clinical Research News | Namita Limaye, Research VP at IDC, gave a broad overview of IDC’s survey findings over the past 18 months at this week’s Bio-IT World Conference and Expo held in Boston and online. She highlighted trends in the life sciences and clinical trials industries that included increased collaboration, speedier adoption of technologies, reliance on real world data, and more.

    Sep 22, 2021
  • Machine Learning Adds Speed To Electronic Health Records-Based Phenotyping

    Clinical Research News | In clinical informatics research, creation of rule-based algorithms is a robust method for mining electronic health records (EHRs) to classify diagnoses. But the process requires considerable time and expertise to build, refine, and deploy, which explains why to date only 81 phenotypes have a publicly available algorithm.

    Sep 21, 2021
  • Real-World Data Suggests Statins Would Effectively Treat Ulcerative Colitis

    Clinical Research News | Researchers at Stanford have published close to 100 papers demonstrating that publicly-available data can be tapped to accelerate clinical translation. They have now integrated real-world molecular and clinical data to show, with astonishing clarity, that statins—the commonly prescribed cholesterol-lowering drug—would be an effective, if unexpected, treatment for ulcerative colitis (UC).

    Sep 16, 2021
  • Foundation Medicine, Science 37 Decentralize Trial For Rare Cancer

    Clinical Research News | Cancer-gene profiling company Foundation Medicine has teamed up with decentralized clinical trial specialist Science 37 to enable home-based clinical trials in oncology. The pilot project with Roche employing this model was launched last December.

    Sep 15, 2021
  • ClinOne Launches Oncology Tool Platform

    Clinical Research News | Later this month, ClinOne will announce a new technology platform specifically for oncology clinical trials, bringing together its solutions for peer referrals, eConsent, video visits, Uber Health, and patient empowerment into a single platform

    Sep 14, 2021
  • How To Diversify Trials: Recruitment Protocols, Other Approaches

    Clinical Research News | Researchers from Beth Israel Deaconess Medical Center (BIDMC) recently reviewed investigators’ planning documents in federally-funded cardiovascular disease trials to determine whether various recruitment strategies impacted the number of Black participants enrolled. They were disappointed by what they found, but others say real-world evidence—not just better recruitment—will most move the needle.

    Sep 9, 2021
  • New Drug Repurposing Approach Could Speed COVID Therapies To The Clinic

    Clinical Research News | In under a year, researchers at the University of Michigan (U-M) have moved from discovery to phase 2 clinical studies for a pair of drug contenders in the fight against COVID-19. The credit goes to a program, newly launched when the pandemic struck, which “systemizes” drug repurposing by helping academic investigators look for existing drugs before trying to create new ones

    Sep 7, 2021
  • Follow the Money: Patient Recruitment, Decentralized Trials, AI in Research

    Clinical Research News | HealthTech SPAC funding, platforms for patient recruitment and decentralized trials, multiple academic grants for dementia research, using AI to watch cells over time, and more.

    Sep 3, 2021
  • Foundation Medicine Integrates with Epic, Launch of Sickle Cell Disease Clin Trials Network, New Products

    Clinical Research News | New video eConsent capabilities from Medidata, Kaia Health revamps C-Suite to expand clinical capabilities, clinical trial partnerships for Curebase, Adagene, and Telix Pharmaceuticals, and Clinerion expands global hospital network. Plus new products from Smart Meter, Digital Science, and Elsevier.

    Sep 1, 2021
  • Biosafety Oversight: A Critical Component of Clinical Gene Transfer Research

    Clinical Research News | The goal of biosafety in research is the management of risk to people and the environment associated with exposure to biological agents and toxins and to genetically modified vectors, DNA or RNA. There are two ways that biosafety oversight of clinical trials could be improved to become more consistent and transparent. First, federal rules governing which clinical trials require biosafety approval should be broadened and clarified. Second, the National Institutes of Health (NIH) could restore certain aspects of central risk assessment and guidance that were eliminated recently.

    Aug 31, 2021
  • How Doctors And Patients Are Partnering To Evolve The Decentralized Clinical Trial Model

    Clinical Research News | Decentralized clinical trials (DCTs), which leverage technology to collect patient data remotely, have recently begun to change the industry by helping to increase trial access and participant diversity. As DCTs continue to evolve, we have learned that technology can allow us to bring research into almost any clinical setting. In fact, patients can even identify trials, and bring their own physician on board to administer most of the necessary care to participate; a concept I like to call Bring Your Own Physician (BYOP).

    Aug 26, 2021
  • Looking Closely at Cancer Clinical Trials and the Patient Experience

    Clinical Research News | In a study published this month in JAMA Network Open, a team from the University of Pennsylvania School of Nursing worked with 20 patients with cancer that withdrew or were withdrawn from a cancer clinical trial to help clarify the post-trial needs of cancer patients participating in clinical trials and define what constitutes responsible transitions when patients exit trials.

    Aug 25, 2021