• USC Addresses Brain Research Diversity Crisis in India, Pfizer Advances Research for Additional COVID-19 Treatments, More

    Clinical Research News | A clinical trial supply forecasting service helps inform decision-making related to the quantity of medication produced for use in clinical development; a new innate immune biology lab to study the innate immune system and its cells; a post-stroke atrial fibrillation (AF) platform collects real-time imaging data and securely transfers it to the central investigators to improve the detection of AF; and more.

    Mar 30, 2023

  • Dealing With Data Biases and Overwhelm in Clinical Research

    Clinical Research News | At a panel presentation during the ViVE event in Nashville, Tenn., on Monday, Kulleni Gebreyes of Deloitte, hosted a discussion about unbiased data in health care.

    Mar 29, 2023

  • Follow the Money: University of Utah Accelerates Heart Failure Gene Therapy Research, OpenClinica’s Cloud Technology to Simplify Clinical Trials, More

    Clinical Research News | Funding for progressing a neurodegenerative disease drug candidate into clinical development, virus filters engineered to provide superior filter productivity and robust viral clearance during clinical trials, developing messenger RNA therapies for applications in cancer immunotherapy and exploring therapeutic alternatives with various nucleic acids, and more.

    Mar 28, 2023

  • MUSC’s Opt-Out Approach To Recruitment Proves Popular With Patients

    Clinical Research News | Consumers are by now accustomed to opting out of everything from unwanted telemarketing calls to text messages about a flash sale at their favorite department store. It is perhaps unsurprising then that they would not object to the idea of an opt-out approach to cold contact about a clinical trial for which they are potentially eligible.

    Mar 23, 2023

  • Gender Parity Still A Stretch Goal For Global Trials

    Clinical Research News | Two different perspectives on the participation of women in clinical trials arise when looking at the situation locally and internationally. At the ground level in the U.S., at least on protocols that don’t exclude them, women often outnumber men by a wide margin even if all socioeconomic subgroups aren’t represented. On the other hand, females account for only about 31% of study participants across all 450,000 ongoing global trials.

    Mar 15, 2023

  • Community Pharmacists Can Help Sponsors Meet Trial Diversity Requirements

    Clinical Research News | Independent, community-based pharmacists are in an ideal position to improve the equitable representation of racial and ethnic groups in clinical research, as required under the recently enacted 2023 omnibus spending bill. How to accomplish this is spelled out in a white paper, termed the Diversity Now protocol, newly published by the company that focuses on improving the recruitment and retention of underrepresented populations.

    Mar 14, 2023

  • ‘Circle Of Trust’ Model For Recruiting Indigenous Populations Into Trials

    Clinical Research News | An existing trust-based intervention known to increase minority participation in clinical trials won’t do much to improve the representation of American Indians (AI) and Alaska Natives (AN) in studies, according to Arch G. Mainous III, Ph.D., professor in the department of community health and family medicine as well as health services research, management and policy at the University of Florida. Community engagement is critical when dealing with indigenous populations from a particular tribe or reservation.

    Mar 9, 2023

  • Jill Pellegrino of CVS Health Clinical Trial Services on Using RWE to Improve Clinical Trial Efficiency and Applicability

    Clinical Research News | In 2020, retail pharmacy giant CVS launched CVS Health Clinical Trial Services to increase patient recruitment efforts and encourage equitable participation. In the latest Scope of Things podcast episode, Jill Pellegrino, vice president of recruitment and RWE at CVS Health Clinical Trial Services, speaks with host Deborah Borfitz about the company’s extensive clinical trial offerings.

    Mar 7, 2023

  • Tackling the Logistical Challenges of DCTS: Joined Up Services and Owning the Process

    Clinical Research News | When hybrid and decentralized clinical trials rely on a patchwork of different suppliers, vendors, and couriers, logistics become a substantial administrative burden for sponsors and sites alike. That’s why an integrated project management approach to home health and distribution is vital.

    Mar 3, 2023

  • Digital Health Technologies Gaining Ground In Clinical Trials

    Clinical Research News | Growing interest in the use and utility of digital health technologies (DHTs) was on full display at the recent Summit for Clinical Ops Executives. While outsourcing professionals were learning from Merck’s experience in evaluating and selecting DHT suppliers, digital data specialists were getting a progress update on a study comparing sensor-based symptom measures with traditional clinician-rated assessments in patients with early, untreated Parkinson’s Disease.

    Mar 1, 2023

  • Best-Yet Systemic Biomarker Predictor Of Knee Osteoarthritis Progression

    Clinical Research News | Researchers at Duke University have come up with the new “best-in-class” systemic biomarker predictive of clinically relevant knee osteoarthritis that significantly outperforms the top-rated urine test when it comes to recognizing disease progression. Development of the targeted multiple reaction monitoring proteomic panel has been a 12-year labor of love for the team.

    Feb 28, 2023

  • Patient Registries Now Fueling Regulatory Decision-Making

    Clinical Research News | The challenges and opportunities of working with patient registries, one of the most frequently used real-world data types supporting pharmaceutical drug development, was the subject of a series of use cases presented at the recent Summit for Clinical Ops Executives.

    Feb 23, 2023

  • MD Anderson Deploys Technology for Novel Cancer Therapy Research, Personalis and Moderna Evaluate Investigational Personalized Cancer Vaccine, More

    Clinical Research News | A University of California, Davis research team predicts the female response based on input from readily available male clinical trial participants; a new solution enables researchers to measure whole transcriptomes and paired T-cell receptor sequences—alpha and beta chains—in up to 1 million cells; Insilico Medicine receives Orphan Drug Designation from the FDA for a first-in-class small molecule inhibitor designed to treat idiopathic pulmonary fibrosis; and more.

    Feb 23, 2023

  • Pragmatic Trials Testing ‘Passive Digital Marker’ For Detecting Dementia

    Clinical Research News | Research scientists at Indiana University–Purdue University Indianapolis and Regenstrief Institute have developed a “passive digital marker” (PDM), powered by machine learning, to help identify people at risk for Alzheimer’s disease and related dementias at an earlier stage in primary care settings. Application of the PDM will now be tested in the real world in a pair of pragmatic randomized controlled trials.

    Feb 22, 2023

  • AI Transforming Real-World Clinical Development

    Clinical Research News | Artificial intelligence and machine learning solutions bringing tangible improvements to clinical trial conduct took center stage at the recent Summit for Clinical Ops Executives, where a succession of companies—including Pfizer, AbbVie, and IQVIA—took to the podium to share their use cases and road to success.

    Feb 21, 2023

  • Follow the Money: Whole Blood Product Transfuses Soldiers in Active Combat, UC Davis Launches Psychedelics and Neurotherapeutics Research Institute, More

    Clinical Research News | Funding for various metabolomic research advancements, therapeutic developments, and precision medicine applications, a new federally funded research program testing the safety and efficacy of tools for trauma victims with numerous complex injuries, accelerating research across the field of synthetic biology, and more.

    Feb 21, 2023

  • Precision Oncology: Targeting the Ongoing Clinical Staffing Challenges

    Clinical Research News | Recent staffing challenges spurred by the COVID-19 pandemic have played a sustained, negative role in clinical trial workflows. However, through precision technology, healthcare providers can decrease turnover rates and reduce the major ongoing clinical trial workflow challenges resulting from lower personnel.

    Feb 17, 2023

  • A Long Time Coming On Digital Endpoints

    Clinical Research News | Efforts to use digital endpoints to modernize clinical trials have been slowed by an assortment of challenges. But the field will be getting a big push in the right direction in another few months when the first hard evidence will be published demonstrating digital endpoints can live up to their promise of delivering smaller, speedier trials.

    Feb 16, 2023

  • Merck Outlines Structure of Saama Partnership on AI for Clinical Data

    Clinical Research News | AI for clinical data was the subject of several presentations at the recent Summit for Clinical Ops Executives event in Orlando, Fla. SCOPE speakers from across big pharma shared their use cases in applying artificial intelligence and machine learning to various parts of the clinical research process.

    Feb 15, 2023

  • Janssen Redefining Decentralized Clinical Trials With Retail And Mobile Clinics

    Clinical Research News | Janssen Pharmaceuticals (a Johnson & Johnson company) is customizing the way it conducts clinical trials, utilizing retail clinics on their own or with an affiliate healthcare system as well as mobile clinics stationed outside long-term care facilities in the community. This will enable study teams to choose the model that best suits a trial and participants to “choose the adventure” they most prefer.

    Feb 14, 2023