Principal investigators' work is much needed and appreciated, but the issue of PI compensation poses challenges for both sites and sponsors. Stamford Hospital Executive Director of Research Suzanne J. Rose, PhD discusses.
- Best Practices For Trial Design And Site Selection In Pediatric Clinical Trials
- $25 Million Awards Help Cancer Researchers Make Clinical Trial Inroads
- For Hybrid Trials, Have Some Faith … In Sites
- Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs
- Meaningful Industry Change Means Balancing Tech And Human Touch
- Unleashing The Power Of Investigator-Sponsored Research (ISR) And Investigator-Initiated Trials (IIT)
- Early Exposure & Site Network Support Enable PI’s Enduring Interest In Research
GUEST COLUMNISTS
-
Early Exposure & Site Network Support Enable PI’s Enduring Interest In Research
Seasoned Phase 1 principal investigator and site co-director Manish Sharma, MD, recounts his career thus far as a PI, offering insights into PI motivation, retention, and satisfaction.
-
Take-Home Microdosing Trial Studies Sub-Hallucinogenic For Depression
MindBio Therapeutics CEO Justin Hanka details the company’s Phase 2a clinical trial investigating the use of a take-home microdosing regimen for depression.
-
What Can Digital Patient Twins Do For Clinical Research?
Digital patient twins have the potential to vastly improve our current healthcare systems by offering personalized therapeutics, enhanced health monitoring, and streamlined pharmaceutical manufacturing, including clinical trials.
-
Fortifying The 3 Cs With Strategic Approaches And Tools
In part two of this series, the authors continue the discussion by identifying specific tools and strategies that companies can use to improve communication and collaboration.
-
Assessing The 3Cs: Does Your Organization Have The Foundation For Clinical Trial Success?
In part one of this series on exploring the importance of culture, communication, and collaboration, the authors discuss the makings of a strong company foundation and offer an assessment plan meant to reveal strengths and weaknesses in those three areas.
-
Validating A Better ALS Biomarker With Coya’s Fred Grossman
Coya Therapeutics President and CMO Fred Grossman, DO, FAPA discusses a potential new biomarker for ALS — 4-HNE, an oxidative stress biomarker — and how it could be more effective than the current standard, NfL.
-
Will Today’s Clinical Trial Trends Become Tomorrow’s Routine?
Clinical trial trends can be divided into two groups — those related to changes in the conduct of clinical trials and those related to the changes in therapeutic areas. Will these trends hold steady as 2024 unfolds?
-
For Veteran PI, Research Requires Motivation, Dedication, And CRO Support
Principal investigator Dr. Luke Twelves discusses how he remained motivated to continue conducting trials and shares insights into what he thinks will inspire others to do the same.
CLINICAL TRIAL WHITE PAPERS
-
CGT Trials — The Synergy Of CRO And Specialty Logistics Collaboration
Learn how the right CRO partner is crucial to support the uniquely complex logistical needs of CGTs while prioritizing the working conditions of investigators and the comfort of trial participants.
-
The Regulatory Evolution And Data Revolution In Medical Device Development7/4/2022
The Life Sciences and Healthcare industries are among the most heavily regulated industries in the world. This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in-vitro diagnostics (IVD) sector is also going through regulatory change - a topic that is out of scope for this paper.
-
The Unique Value Of Integrated Safety Services And Technology10/13/2023
In your search for an integrated safety partner, begin by assessing a vendor’s previous experience and whether their PV knowledge aligns with the needs of your product portfolio.
-
C3 Glomerulopathy: The Asia Pacific Clinical Trial Landscape1/6/2023
C3 Glomerulopathy (C3G) is a complex, rare complement-mediated renal disease. Find out its effects in the Asia Pacific.
-
Using Electronic COAs/PROs To Capture The Patient Experience11/16/2022
As telehealth solutions and mobile health devices help empower decentralized clinical trials, discover how study sponsors look for ways to further improve the patient and site experience while delivering high-quality data.
-
Cell And Gene Therapy Logistics10/27/2023
Take an in-depth look at the obstacles encountered during the Cell and Gene Therapy (CAGT) Logistics asset journey and how to overcome them.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Mobile Research Units Enable Large Volume Screenings2/22/2023
Learn how recruitment and screening of potential patients was made possible for a Phase 3, adult patients, clinical trial by utilizing MRUs to screen large volumes of patients at community events.
-
Moving From Clinical Development To BLA Through Strategic Planning10/23/2023
Uncover how a small biotechnology company was able to successfully file its Biologics License Application submission to the U.S. Food and Drug Administration after undergoing several personnel losses and shifts.
-
Professional Services Expedite Hospital's Study Process11/17/2023
Explore the details of a transformative partnership where a children's hospital was able to overcome coverage analysis and budget negotiation issues despite a significant staff turnover.
-
How We Achieved 100% Recruitment 7 Months Ahead Of Schedule6/14/2022
Uncover how a mid-sized European contract research organization successfully completed a Phase 3 lung cancer clinical study jointly with a global CRO.
-
ClinCard Supports Tufts Medical Center’s Commitment To Care And Research2/17/2023
Administrative work is to be expected at any site. Explore how improved and efficient administrative processes can ensure a better experience for patients and the team.
-
Expert Consulting And MRCT Strategy Rescues Oncology Program1/3/2024
Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.
NEWSLETTER ARCHIVE
- 05.15.24 -- Unleashing The Power Of ISR And IIT
- 05.15.24 -- Unlocking Innovation: 6 Decades Of DIA's Global Journey
- 05.14.24 -- 3 Areas Where AI Could Revolutionize Patient Recruitment And Retention
- 05.14.24 -- Simplifying Complex Clinical Trials With eCOA
- 05.13.24 -- For Veteran PI, Research Requires Motivation, Dedication, And CRO Support
CLINICAL LEADER CONTENT COLLECTIONS
With the advent of decentralized clinical trials and the increased fascination and exploration with technology-assisted processes bringing new data — and more of it — the importance of intentional data collection cannot be overstated. Our latest ebook from Clinical Leader brings you helpful articles on a topic that is arguably the most crucial part of the study process.
More Content CollectionsFOCUS ON PATIENTS
-
“Children are not small adults," reminds Katie Smentek, MD, a PI at Mankato Clinic. Here, Smentek shares her advice for designing trials and selecting sites for pediatric patients.
-
Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction.
-
Despite the progress made in including women in clinical trials, challenges persist. Hera Biotech CEO Somer Baburek explains why the fight for inclusion isn't over.
EMBRACING DIVERSITY & INCLUSION
-
Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults.
-
The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
-
The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.