• 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

  • 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

  • Patient-Centric Focus, Awareness, Technology Can Fix Pharma’s Lack of Progress on Trial Diversity

    Clinical Research News | Conversations of diversity in clinical trials has been just talk for a long time. It’s great that study results are being reported with demographic data about race and ethnicity, but it’s still up to the individual pharma company whether it wants to report diversity or not. This is not the path toward meaningful change.

    Jul 30, 2021

  • Machine Learning Can Predict If COVID-19 Trials Will Succeed

    Clinical Research News | A pair of computer scientists at Florida Atlantic University have come up with a machine learning approach to predict the likelihood of a clinical trial being terminated down the road and attribute factors contributing to study termination or success. When applied to the flurry of COVID-19 trials launched since early last year it performs particularly well.

    Jul 29, 2021

  • Data Privacy And Patient-Centeredness Driving Technology Adoption

    Clinical Research News | The potential of artificial intelligence (AI), internet-connected devices, wearables, and cloud computing to disrupt traditional clinical trials was explored during a presentation on patient-centered endpoints at the recent DIA 2021 Global Annual Meeting. The common goal is to make studies more palatable for participants, improving their engagement and retention, and to help pick up the pace and cost of making new medicines.

    Jul 26, 2021

  • 5 Reasons Why a Decentralized Method Works for Clinical Trials

    Clinical Research News | With sponsors like IQVIA, Pfizer, and GSK joining the Decentralized Trials & Research Alliance and the FDA giving decentralization its nod of approval, it’s safe to say the clinical research industry will continue to embrace decentralized trials.

    Jul 23, 2021