• Looking Forward to EU Regulation (EU) No 536/2014

    Clinical Research News | The EU Clinical Trials Register will be implemented on 31 January 2022, with the launch of the harmonized Clinical Trials Information System (CTIS) in all EU and EEA Member States. It is one of the most fundamental changes in the regulatory landscape for clinical trials in Europe. It is both historic and exciting.

    Jan 26, 2022

  • Canadian Brain Institute Opens Data Sharing on Alzheimer’s, Parkinson’s, More

    Clinical Research News | After a decade of methodical preparation, Canada’s Ontario Brain Institute's (OBI) neuroinformatics platform, Brain-CODE, launched its open data sharing feature for global brain disorder research.

    Jan 25, 2022

  • Logistical Challenges Of The ‘Reverse Supply Chain’ For Biospecimens

    Clinical Research News | The pandemic has served to highlight shortcomings of traditional practices around the cold-chain transport of biospecimens for clinical trials—including no backup plans when airports, borders, and study sites unexpectedly close. Even in normal times, default choices such as contracting mostly if not exclusively with premium couriers, can “artificially increase the cost of clinical trial conduct,” in the view of Thomas McDonald, associate director of biospecimen logistics for Bristol Myers Squibb Co. (BMS).

    Jan 24, 2022

  • Where AI Can Add Efficiencies To Clinical Trials

    Clinical Research News | Acceptance of artificial intelligence (AI) in clinical research is on the rise thanks, in part, to its pairing with human expert oversight. The result is faster, more efficient clinical trials with less of the bias associated with purely manual evaluations while sidestepping the potential risks of AI.

    Jan 20, 2022

  • Trials@Home Exploring European Experience With Decentralized Model

    Clinical Research News | Next year, a pan-European pilot study gets underway comparing the performance of hybrid and fully decentralized clinical trial models with conventional brick-and-mortar settings where the endpoints are operational metrics such as recruitment speed and diversity of enrolled populations. The focus of the study—the cornerstone of the broader Trials@Home project—is to see what decentralized approaches are possible across a continent with a mix of different languages, regulatory authorities, and privacy laws.

    Jan 18, 2022

  • Parallelization Now Proven Approach in Clinical Trials

    Clinical Research News | Technology will continue to play a large role in how we conduct trials, but new ways of working will have to be implemented to truly drive change. During the COVID-19 vaccine trials, several new approaches emerged that helped speed the trials and bring the vaccines to market in record time. One such approach is fast-tracking, or parallelization.

    Jan 14, 2022

  • 2022 Participant Engagement Award Finalists Announced

    Clinical Research News | Finalists have been named for the sixth annual Participant Engagement Award. Their work will be highlighted, and a winner will be named at the upcoming 2022 Summit for Clinical Ops Executives (SCOPE), February 7-10 in Orlando, Fla.

    Jan 13, 2022

  • Seqster, National Pancreas Foundation, Launch Pancreatic Disease Patient Registry

    Clinical Research News | Seqster announced today a multi-year partnership with The National Pancreas Foundation, a nonprofit organization that provides hope for those suffering from pancreatitis and pancreatic cancer, to create the country’s largest, most inclusive pancreatic disease patient registry. The registry uses Seqster technology to connect to any EHR, genomic DNA test, and wearable/remote monitoring device, providing patients with a complete longitudinal health record in real-time.

    Jan 11, 2022

  • Bayer Pilots Platform Turning Surplus Clinical Trial Kits Into Donations

    Clinical Research News | The scalable, not-for-profit technology platform Kits4Life is helping the clinical trial community divert unused and excess study supplies to healthcare organizations around the world that are qualified to accept humanitarian aid. In doing so, the cross-sector initiative has turned the “meaningless act” of destroying the surplus into an impactful gesture of corporate social responsibility and sustainability.

    Jan 11, 2022

  • Trendspotting: Decentralized Trials Maintain Momentum, Additional Remote Solutions, AI and Reducing Bias

    Clinical Research News | We spoke with clinical research leaders to gain insights into expectations for the coming year. They predicted direct-to-patient drug shipments, supply chain digitization, payviders, and AI with wearables and other clinical data, and more.

    Jan 10, 2022

  • Multiomics Used To Stratify Multiple Myeloma Patients Into Affinity Groups

    Clinical Research News | All new multiple myeloma patients being treated at the Tisch Cancer Institute at Mount Sinai are now being assigned to one of 12 subgroups based on shared genetic and molecular features of their disease. The multiple myeloma patient similarity network (MM-PSN) is one of the latest computational modeling tools being used here to translate clinical data into better treatment decision-making in the clinic, and the first to apply multiomics to the stratification of patients with the blood cancer.

    Jan 6, 2022

  • Balancing Convenience And Engagement In Decentralized Clinical Trials

    Clinical Research News | Decentralized clinical trials (DCTs) are a valued option for many would-be study participants as well as a chance to customize the research experience and cater to their needs, according to Ken Getz, founder and chair of the Center for Information & Study on Clinical Research Participation (CISCRP). Findings of CISCRP’s 2021 Perceptions and Insights study indicate interest in DCT approaches is quite high provided they don’t interfere with the quality of patients’ personal relationship with study staff.

    Jan 4, 2022

  • 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