• Wholly Remote COVID-19 Drug Trial Gets High Marks On Operational Front

    Clinical Research News | A fully remote randomized clinical trial, born of necessity in the early days of the pandemic, provides evidence that the study model is viable even when testing drugs with potential heart rhythm effects. Whether the concept will be as well embraced post-pandemic remains anyone’s guess.

    Mar 9, 2022

  • Sponsors Validating Multiple Digital Endpoints For Clinical Trials

    Clinical Research News | The development and validation of novel digital endpoints in clinical trials was the subject of several case studies shared at the recent Summit for Clinical Ops Executives (SCOPE), including a pilot study of a speech-language assessment tool by Regeneron Pharmaceuticals and trials of at-home monitoring devices for gait speed and nocturnal scratching by Pfizer. Rapid adoption of wearables has provided opportunities to innovate and better understand patients and biomarkers of health abnormalities

    Mar 7, 2022

  • Fast Track Designation for Myeloid Checkpoint Inhibitor, Neuromodulation for Heart Failure, Digital Twins in Trials, More

    Clinical Research News | A first-in-class myeloid checkpoint inhibitor was granted fast track designation, clinical trial results are in for vagus nerve stimulation to treat heart failure, a clinical trial launches to assess glycosaminoglycan profiling as all-cancer detection method, and new agreements have been entered or extended to promote decentralized trials and the use of digital twins

    Mar 2, 2022

  • Rules And Roles Of Decentralized Clinical Trials Coming Into View

    Clinical Research News | The current regulatory landscape for decentralized clinical trials (DCTs), and a trio of use cases focused on medical devices and in vitro diagnostic (IVD) products, were among a bevy of presentations on the decentralized study model at the recent Summit for Clinical Research Ops Executives (SCOPE).

    Mar 1, 2022

  • Follow the Money: Immunological Therapeutics, Signal Regulatory Protein-Targeting Therapeutics, Regulatory Compliance Technology

    Clinical Research News | New pharma-focused venture cap fund, funding to drive trials for treating immunological and inflammatory diseases and shingles, and more.

    Feb 28, 2022

  • Takeda Test-Driving Clinical Trial Software Prior To Study Starts

    Clinical Research News | Takeda Pharmaceuticals is implementing a “digital visit testing site” for clinical trials, using internal volunteers to test-drive devices in a sandbox environment simulating real-world study conditions prior to their actual deployment. It’s an element of the company’s just-in-time software builds that kick off this month in “proactive preparation for the future.”

    Feb 25, 2022

  • Scoring System For Predicting ARDS Treatment Response In COVID Patients

    Clinical Research News | Researchers from Massachusetts General Hospital (MGH) and the University of Cyprus (Cyprus) have come up with a mathematical model that can predict treatment response for different subpopulations of patients with COVID-19 complicated by acute respiratory distress syndrome (ARDS) and determine biologic mechanisms of patient outcome.

    Feb 23, 2022

  • DE&I Initiatives May Need An Accessibility Component

    Clinical Research News | Ensuring the Black voice in clinical research was the focus of a panel discussion on diversity, equity, and inclusion (DE&I) at last week’s Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. The conversation was led by two-time cancer survivor Kimberly Richardson, president of the Black Cancer Collaborative, who vividly recalls being scolded and silenced when she questioned why her slow-growing granulosa cell tumor needed to be aggressively treated with three-drug medicinal cocktail.

    Feb 21, 2022

  • Engaging Local Communities To Support Patient-Centric Clinical Trials

    Clinical Research News | Ways to effectively engage local communities in clinical research—as trial participants, study sites, and referral partners—was a top topic of conversation at the recent Summit for Clinical Ops Executives (SCOPE) in Orlando, Fla. Karen Correa, head of global clinical operations at Takeda Pharmaceuticals, focused on tactics for educating and motivating healthcare professionals to be ongoing clinical trial referrers, while Kafayat Babajider, associate director of patient portals for Janssen Research and Development, provided a status report on its six-month-old, insights-driven My Trial Community platform.

    Feb 18, 2022

  • New Program Brings AI to Enrolling Cancer Patients in Trials

    Clinical Research News | A leader in precision medicine and AI-enabled clinical trial enrollment for oncology patients has launched a program designed to simplify the enrollment process and open clinical trial access to all cancer patients. The goal of Massive Bio’s new 100K Singularity Program, which uses artificial intelligence (AI) and real-time access, is to transform the current clinical trial enrollment process.

    Feb 16, 2022

  • Inclusive Research Is Good For Business As Well As Science

    Clinical Research News | Inclusive clinical research matters to patients, shapes good science, and is imperative to business success, according to Meghan McKenzie, principal inclusion, internal partnering, in Genetech’s Chief Diversity Office. How to go about increasing diversity in clinical trials was the focus of her keynote presentation at last week’s Summit for Clinical Op Executives (SCOPE) in Orlando, Florida.

    Feb 15, 2022

  • Novartis Has An Evidence-Based Connected Health Vision

    Clinical Research News | Novartis has plans to develop one or more “connected health” solutions—a universe that includes connected devices, wearables, and software as medical devices (SaMD)—to be part of its drug program over the next five years. Its fledging digital health platform will be putting those tools in the hands of clinicians, patients, and researchers to improve the overall healthcare experience and access to trials, according to the keynote last week at the Summit for Clinical Ops Executives (SCOPE).

    Feb 14, 2022

  • PharmaLedger Project To Create Blockchain-Based Clinical Trial Solution

    Clinical Research News | A 36-month PharmaLedger project sponsored by the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations is attempting to create a scalable blockchain platform with use cases for clinical trials as well as supply chain and health data. In the trials arena, the focus initially was on eConsent, but the public-private initiative is now intent on creating an end-to-end solution for clinical trial conduct, according to a report given yesterday at the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida.

    Feb 10, 2022

  • Pandemic Pivots That Need To Persevere

    Clinical Research News | A fireside chat on what “fit-for-future” data operations might look like in a post-pandemic world was the topic of a keynote presentation on day two of the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida yesterday. The risk-benefit ratio on many innovative methodologies and technologies has flipped over the past two years, elevating their value in the “new normal” moving forward, as shared by executives from a trio of leading biopharmaceutical companies.

    Feb 9, 2022

  • Merck Using Virtual Reality To Make Pediatric Study Visits More Pleasant

    Clinical Research News | Merck took first place honors at Participant Engagement Award ceremonies on the opening day of the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida yesterday. Other honorees included Guardant Health and Tryl.

    Feb 8, 2022

  • Follow the Money: New Clinical Trials Platform, AI For Clinical Prediction, Cancer Risk Stratification

    Clinical Research News | Autoimmune disorder treatments, AI-Based clinical prediction, cancer risk stratification, available funding for clinical efficacy research, and more.

    Feb 8, 2022

  • Innovative Study Site Partnerships Help Sponsors Address The Challenges of Patient Centric Trials

    Clinical Research News | It is no surprise that the global pandemic has created challenges in allowing trial sites to conduct research focusing on efficiency and quality care. However, it has also brought to the forefront the long-established systemic issues that site teams face in trial operations and related patient care and staff burdens. Ongoing issues such as increasing administrative responsibilities and timely patient onboarding make it difficult for site teams to focus more of their time on the bigger picture of high-quality patient care.

    Feb 4, 2022

  • Trials for Mild Cognitive Impairment, Inflammatory Bowel Disease, MS; New ePRO Offering; THREAD Acquires InVibe

    Clinical Research News | Trials are in line for treating mild cognitive impairment, inflammatory bowel disease, and MS; ObvioHealth announces a new ePRO offering; positive results for Renalytix risk monitoring tool in diabetic kidney disease study; acquisitions, mergers, and more.

    Feb 2, 2022

  • Overcoming The Challenges of Outsourcing Rare Disease Trials

    Clinical Research News | Anyone who has ever played the game of telephone as a child knows only too well how a message can become completely scrambled by the time it passes through a succession of people. A similar type of communication breakdown can happen when a protocol gets communicated by a study sponsor to a contract research organization (CRO), and then handed off to study managers or monitors and ultimately clinical trial sites, especially for rare disease trials.

    Jan 31, 2022

  • The Emerging Role Of Pharmacists In Clinical Research

    Clinical Research News | The role pharmacists play in the community is the same one they should be playing in clinical research, according to Gerald Finken, founder and CEO of RxE2 whose mission it is to help make that happen. His belief is that “community-based clinical trials” in general can be better for patient care, the pharmacy as a profession, and study sponsors who have long had trouble recruiting enough patients into their studies.

    Jan 27, 2022