• Follow the Money: Blood Collection Tech, SPR-Based Proteomics, AAV Gene Therapy Vectors, More

    Clinical Research News | Technologies for blood collection and testing, immune-competent organoids, flow cytometry for cell therapies, and SPR-based proteomics; funding for Brown Cancer Center

    Dec 28, 2021

  • Top Stories of 2021: COVID-19 Vaccines, Decentralized Trials, External Control Arms, Increased Diversity, AI

    Clinical Research News | Businesses everywhere also looked to leverage the COVID-associated disruptions to the benefit of themselves and society—with new technology to enable and facilitate decentralized clinical trials, arguments for the increased acceptance of external control arms, and the place of AI in clinical data. We also explored practical ideas for increasing clinical trial diversity and reported on a new initiative for better data sharing and standardization in the realm of rare diseases.

    Dec 27, 2021

  • Equipping Your Cold Chain Infrastructure for Decentralized Clinical Trials

    Clinical Research News | Decentralized clinical trials (DCTs) mitigate the burden of transportation, lodging, meals, and dependent care that often pose barriers to study participants. Still, the adoption of DCTs requires a fundamental shift in infrastructure to maintain compliance. This not only includes a shift to the cloud for virtual collaboration between stakeholders and data sharing, but also the elements of infrastructure that cannot be virtualized, such as the cold chain.

    Dec 23, 2021

  • ArisGlobal’s FDA Rollout, Science 37 in China, Russia, More

    Clinical Research News | ArisGlobal announces FDA go-live for adverse event reporting, Metabolon plans collaborations with Boston hospitals for lactation research, THREAD names Amazon-alum to Chief Product Officer role, and Science 37 expands to China and Russia. Plus new products from Certara, Leica Microsystems, and more.

    Dec 22, 2021

  • Recognize, Recall & Refine: Eliminating Bias in Computer Vision

    Clinical Research News | More and more, we’re seeing AI’s ability to transform drug development. It plays an increasing role in evaluating how patients respond to treatment during a clinical trial and helping to extract meaningful insights that can improve drug development and bring drugs to market faster. But, the power of AI lies in the quality and quantity of its data backbone, so consistently evaluating that data to ensure it is representative of all patient populations is crucial to its success.

    Dec 17, 2021

  • Seven Bridges Launches the Unified Patient Network With Genomic, EHR Data

    Clinical Research News | Seven Bridges Genomics has launched a new subsidiary, the Unified Patient Network (UPN), to facilitate clinical research and collaboration between participating health systems and biopharma companies. The UPN will combine de-identified sequencing data and EHR content for five million patients and allow biopharma companies to license cohorts from that dataset for research. Licensing fees from biopharma will fund the network.

    Dec 13, 2021

  • Improving Public Health Through Drug Monitoring

    Clinical Research News | From a regulatory point of view, detailed and complete monitoring and reporting of adverse events and other drug problems has been recognized as the best way to build a strong, sustainable system for medicine safety and for public confidence in medicines.

    Dec 10, 2021

  • PCORI Approves Funding For mHealth, CARES Trial, More

    Clinical Research News | The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved two slates of research funding awards totaling $49.5 million to support nine new comparative clinical effectiveness research (CER) studies aimed at improving care for adults and children across a range of health conditions.

    Dec 8, 2021

  • Follow the Money: 3D Telepresense, Transplant Rejection Trials

    Clinical Research News | Clinical trials for lung transplant rejection and sickle cell disease, immersive 3D telepresense for remote patient engagement, and precision dosing technology.

    Dec 2, 2021

  • Engaging Risk-Based Quality Monitoring Teams Through Role-Playing

    Clinical Research News | Most pharmaceutical companies today have a dedicated team for risk-based quality management (RBQM) whose job it is to imagine the many ways clinical trials could go wrong to prevent their failure. Gone are the days when averting risk was largely an exercise in source data verification based on the perceived difficulty in study execution, says Marcin Makowski, M.D., Ph.D., head of centralized monitoring and data analytics at GlaxoSmithKline (GSK).

    Dec 1, 2021

  • Roche Announces IMPACT Trial Results, RWE Acquisitions, More

    Clinical Research News | Acquisitions for THREAD, Elsevier, and Global Healthcare Opportunities. Partnerships for international trials and AI-based clinical trial acceleration software. Plus new products from Intuity Medical, Florence, uMotif, and more.

    Nov 30, 2021

  • (Clinical) Trial or Error: The Modernization of Respiratory Clinical Trials

    Clinical Research News | Historically, clinical trials are slow and costly, and of all therapeutic areas, none is more expensive than respiratory trials. How can the pulmonary field that is still struggling to cope with COVID-19, massive wildfires, and the epidemic of lung injury due to vaping, meet the critical need for accelerated drug development and improved clinical care? The answer must come directly from investigators and clinicians doing the work, applying technology in new ways based on what they’ve learned.

    Nov 23, 2021

  • Simplifying CDISC Compliance With Cloud-Based Clinical Metadata Repositories

    Clinical Research News | Although CDISC standards are clearly helping to expedite the review of submissions, many organizations are completing this compliance step at the end of a clinical trial. The data rework involved in this process requires significant time and resources, particularly as metadata is often held in disparate systems and the evolving standards tend to be implemented manually. Clinical metadata repositories (CMDRs) can be used to embed CDISC standards into the study’s design, build and submission.

    Nov 19, 2021

  • Gut Microbiome Linked To Aggressive Prostate Cancer

    Clinical Research News | Evidence has been mounting for decades that what men eat can lower or raise their risk of prostate cancer—including aggressive forms of the disease that can be lethal. But that’s only part of the story.

    Nov 18, 2021

  • COVID Vaccine Trials Offer Lessons For Improving Clinical Trial Diversity

    Clinical Research News | Concerted effort was required to ensure equitable inclusion of Black, Indigenous, and People Of Color (BIPOC) communities in COVID-19 vaccine trials—a complete reversal relative to historic norms. It would have been an impossibility without temporarily slowing or halting enrollment of White individuals so that the demographic composition at final enrollment closely mirrored the larger U.S. population.

    Nov 16, 2021

  • On The Tragic Passing Of Medidata’s Glen de Vries

    Clinical Research News | All of us at Cambridge Healthtech Institute, including the staff of Clinical Research News and the SCOPE conference team, are deeply saddened by last week’s tragic passing of Medidata co-founder Glen de Vries in a small plane crash in New Jersey. Encounters with the clinical trial visionary were always a privilege both for the learning opportunity and because of his especially friendly demeanor.

    Nov 15, 2021

  • Advances In Precision Medicine And Artificial Intelligence Are Set To Transform Cancer Treatment

    Clinical Research News | It’s time for healthcare organizations to open clinical trial options to patients at the beginning of the patient journey, not the terminus.

    Nov 12, 2021

  • What’s Behind Growing Adoption Of Cell-Based Vaccine Platforms

    Clinical Research News | Cell-based vaccines, initially developed to add speed and scale to pandemic response efforts and reduce dependency on chickens in the vaccine manufacturing process, have over the past few years also shown to be more reliably effective than traditional, egg-based products.

    Nov 10, 2021

  • ERT, Bioclinica Rebrand As Clario

    Clinical Research News | ERT today announced that following its early Q2 merger with Bioclinica, the combined company is renamed Clario.

    Nov 3, 2021