• FDA Guidance Could Help Standardize Eligibility Criteria For Lung Cancer Trials

    Clinical Research News | For patients with lung cancer, meeting the eligibility criteria for clinical trials has been a major roadblock to their participation. Over time, studies have grown more complex and expensive and sponsors, eager to optimize the scientific yield of a trial, have become incredibly strict about who meets the enrollment requirements.

    Oct 20, 2022

  • Clinical Trials At The Intersection With Healthcare

    Clinical Research News | Digitalization and the changing regulatory landscape, shared space between routine clinical care and research, the increased complexity of clinical trials in decentralized settings, and practical challenges in providing patient-centric solutions were the focal points of a plenary keynote panel discussion at the recent Summit for Clinical Ops Executives Europe (SCOPE Europe) in Barcelona, Spain.

    Oct 18, 2022

  • When Kids Can Assent To Trial Participation, It Gets Complicated

    Clinical Research News | Experts recently gathered at a bioethics symposium on ethical considerations in research for pediatric populations, hosted by the New York Academy of Sciences, for a panel discussion focused on parental permission and children capable of assenting to participation.

    Oct 13, 2022

  • Digital Strategies For Optimizing Clinical Development

    Clinical Research News | When it comes to balancing the need for high-quality data collection and patient-centric strategies for engaging study participants, hybrid clinical trials utilizing wearable devices and other digital health tools can be challenging to conduct. But when carefully crafted, a digital strategy can also help accelerate trials, improve diversity in recruitment, and improve outcomes for participants.

    Oct 12, 2022

  • Assent Process For Pediatric Trials An ‘Experiment For All Of Us’

    Clinical Research News | Despite regulatory and congressional efforts to protect human research subjects that date back 75 years, ethical dilemmas concerning the participation of pediatric populations in clinical trials persist with no consensus on several key issues—among them the age at which children are too young to understand what they’re agreeing to, and how to respect nonverbal expressions of dissent.

    Oct 11, 2022

  • Select European Research Institutes Become the First to Join International Data Network

    Clinical Research News | Research institutes representing five western European countries—Finland, Germany, Norway, Spain, and Sweden—will become the first to join the Federated European Genome-phenome Archive, an international distributed data network designed to share highly-sensitive human ’omics data internationally.

    Oct 6, 2022

  • University College London’s Dr. Anna David on Increasing the Representation of Pregnant Patients in Clinical Trials

    Clinical Research News | University College London’s Dr. Anna David speaks about the obstacles facing pregnant patients in today’s medical landscape and the past and present strides made to increase their representation in clinical research, all in the latest episode of the Scope of Things podcast.

    Oct 4, 2022

  • Finding More Patients for Clinical Trials by Unlocking Intelligence from Patient Records

    Clinical Research News | Novel artificial intelligence methods have recently been proven clinically valid and valuable for capturing target patient populations investigated by a clinical trial. The intelligence and outputs from novel AI methods benefit clinicians by enabling an ecosystem based on knowledge discovery and sharing in a privacy-preserving manner.

    Sep 30, 2022

  • Singapore’s Largest Respiratory Medicine Research Collaboration, New Brain Health Intervention Research Initiative, More

    Clinical Research News | A first-of-its-kind benchtop platform that enables researchers to assess multiple critical quality attributes of cell samples in a single automated workflow; a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of numerous FDA-approved cancer therapies in new, biomarker-guided patient populations; and more.

    Sep 29, 2022

  • Follow the Money: New Radiation and Immunotherapy Research Initiative, NIH Funds Alzheimer’s and Dementia Research, More

    Clinical Research News | Funding for comparative clinical effectiveness research for patients and caregivers, AI-based biomedical research, diversity in genomic research, and more.

    Sep 28, 2022

  • Balancing People and Technology in Clinical Adjudication

    Clinical Research News | Event adjudication is critical to clinical research for developing life-improving therapies. Implementing a well-managed adjudication program provides sponsors with peace of mind and an unbiased evaluation they may ultimately need to earn regulatory approval.

    Sep 23, 2022

  • Community Registry Grows Research Abilities Of Pulmonary Fibrosis Foundation

    Clinical Research News | In July, the Pulmonary Fibrosis Foundation (PFF) launched the PFF Community Registry to begin collecting data directly from patients in the U.S. with pulmonary fibrosis (PF) and interstitial lung disease (ILD)—together with their nonprofessional caregivers and biological family members—as well as lung transplant recipients previously diagnosed with PF or ILD.

    Sep 21, 2022

  • 3 Ways to Communicate Your Value to Trial Participants

    Clinical Research News | Although we’re seeing an increasing trend of site networks and academic research centers insourcing technology solutions themselves, unless they’re offered an Adaptive Experience that lets them choose how they want to participate at every step of the trial, they aren’t given a choice about using the technology. Keeping technology top of mind is critically important for research solutions to succeed.

    Sep 16, 2022

  • Mount Sinai Aims To Enroll One Million People In Genetic Sequencing Project

    Clinical Research News | The greater New York metropolitan area is the epicenter of an ambitious human genome sequencing research project newly launched by Mount Sinai Health System and the Icahn School of Medicine at Mount Sinai. If the vision is realized, Mount Sinai will enroll a million patients into a study over the next five years that will sequence and analyze the DNA in their blood to tease out the role of genetics and environment on health.

    Sep 15, 2022

  • Public More Protective Of Their Health Information Than Their Biospecimens

    Clinical Research News | In the ongoing debate about whether biospecimens should be covered by human subjects research regulations, bioethicists at the University of Michigan recently added a critical datapoint in disproving one of the arguments—namely, that the public feels more protective of their biospecimens than their health information.

    Sep 14, 2022

  • IVDR Creating ‘Significant Challenges’ For Global Precision Medicine Trials

    Clinical Research News | The impact of Europe’s In Vitro Diagnostic Medical Devices Regulation on global trials for precision medicine was shared at the recent Next Generation Dx Summit held in Washington, DC. IVDR is finally coming into force and creating “significant challenges” for pharmaceutical companies sponsoring studies involving biomarker testing on EU patient samples.

    Sep 13, 2022

  • The Hospital’s Evolving Role in Complementing Clinical Trials

    Clinical Research News | People of color comprise approximately 39 percent of the U.S. population but typically only represent 2 to 16 percent of trial patients. Unlocking the clinical data captured by hospitals and health systems may be the key to closing gaps in care.

    Sep 9, 2022

  • DTRA Releases Lexicon for Decentralized Clinical Research

    Clinical Research News | The Decentralized Trials & Research Alliance announced the release of the DTRA Glossary, an interactive lexicon to provide a consistent vocabulary for and improve the global adoption of decentralized research.

    Sep 8, 2022

  • Moving the Needle: How the Practice of Pharmacy Addresses Key Issues in Clinical Research

    Clinical Research News | In the latest episode of the Scope of Things podcast, Founder and CEO Gerald Finken speaks with host Deborah Borfitz about RxE2, a community-based decentralized trial technology company spearheaded by pharmacists, designed to integrate the practice of pharmacy into every aspect of clinical trials.

    Sep 6, 2022

  • How Patient-Centered Strategies Are Transforming Clinical Trials

    Clinical Research News | Patient centricity is a term on everyone’s lips right now. The life science sector is coming round to the idea that, by putting the needs of the patient at the heart of drug development, we can improve the patient experience and reduce development timelines while creating significant business value.

    Sep 2, 2022