Authors


Sharon Karlsberg

Latest:

Strategies to Close the Gap in Clinical Trial Recruitment

2021 survey highlights challenges and opportunities for investigators, coordinators, and patients.



Tracy Parker and Rebecca Starkie

Latest:

Navigating Evolving DEI Measures in Clinical Patient Recruitment: A Deep Dive

It is crucial throughout the clinical trials space to understand the challenges and triumphs of DEI.


Niketan Panchal

Latest:

AI/ML Approaches to Assisted Medical Writing—Part 2

Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.


Angie Sanchez, MD

Latest:

Clinical Trials and Trust

Understanding the role of social determinants on clinical trial participation and trust.


Avigail Rein, MD, PhD

Latest:

Rethinking ECOG Scores to Improve Patient Access and Clinical Trials Eligibility

Recent study results highlight need for new metrics in ECOG scoring to mitigate variability.


Earl Seltzer

Latest:

Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce

2020 Tufts CSDD study examines relationship between investigative site personnel diversity and study participant diversity.


Nicole Connelly

Latest:

Reducing White Space in Clinical Development

Lessons learned from COVID-19 vaccine trials.


Kevin Peng

Latest:

Adapting Site Selection for Clinical Trial Decentralization and the Future Landscape

Sites not expected to fade away even as DCTs continue to grow past COVID-19.


Stephen Bamford

Latest:

Sharing Anonymized and Functionally Effective (SAFE) Data Standard for Safely Sharing Rich Clinical Trial Data

Presenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.


Helena Lüning

Latest:

COVID-19 Pandemic Exemplifies the Benefits of CROs

The adaptability and innovative capacity of CROs highlighted in EUCROF survey.


Angela Terhune-Hargrove, MHA

Latest:

Breaking Historic Barriers to Ensure Psychedelic Therapy’s Future

Education and equitable access are key to unlocking its full potential in the present and future.


Stephen Bamford, Luk Arbuckle, Pierre Chetelat

Latest:

Diversity in Clinical Trial Data Transparency: A New Horizon for Data Sharing with Truthful Statistics

The pursuit of balance between data utility, privacy protection, and equitable representation.



Elizabeth Rountree

Latest:

COVID-19 Will Have a Heterogeneous Impact on Clinical Trials, Biopharmas

A discussion of how the coronavirus pandemic will have a multitude of impacts on the conduct of trials, as well as on the industry itself.


Scott Schliebner

Latest:

Diversity in Clinical Trials: Path to Achieving Health Equity

Beyond technology, awareness, and access—cultural competence is key.


Laurence Collette

Latest:

Sample Size Re-Estimation as an Adaptive Design

Using the promising-zone approach can salvage an underpowered trial.


Joe Dustin

Latest:

Clinical Trial Optionality: Its Reality is Within Reach

How advanced ePRO tools and approaches offer a path forward.


Amaury Jeandrain

Latest:

How Digital Twins are Driving Sustainability in Clinical Supply Planning

Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.


Dr. Hilde Vanaken

Latest:

Smart New Normal in Medication Management—Personalized, Integrated, and Flexible

What the next generation medication management in clinical trials should entail and insights on smart technologies and synergistic partnerships—backed by real-life implementation use cases.


Caroline Redeker

Latest:

Optimizing Patient Recruitment and Engagement Strategies

Five strategies to reduce risk and achieve deadlines.


Ashish Indani

Latest:

Establishing Metrics and Standardization for Non-CRF Data in EDC

While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.


Edward Triebell

Latest:

A New Era in Clinical Trials

Industry challenges present an opportunity for innovation and the adoption of new solutions, particularly in addressing barriers related to patient recruitment, engagement, and retention.


Sirj Goswami, PhD, and Jason Rizzo, MBA

Latest:

Artificial Intelligence Drives Industry Response to Project Optimus

The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.


endpoint Clinical

Latest:

Case Study: Successful System Integration for Decentralized Clinical Trials endpoint Clinical and THREAD’s Solution Ensures the Successful Flow of eConsent Data

Today’s clinical studies are increasingly complex and require patient-centric trial designs, like decentralized trials, more than ever before. As trials incorporate more decentralized components there is an ever-present need for multiple system integrations to support the various trial functions, with the goal being that all trial data flows seamlessly between systems and is stored in one repository for efficient oversight and analysis. These numerous integrated systems require closely managed integration, synchronization, and supportive partnerships to minimize error and maximize efficiency. In this case study, partners endpoint and THREAD dig-in to explore how IRT can be integrated with decentralized clinical trial (DCT) technology, working through tightly integrated workflows, to provide a streamlined process, a better user experience for Sites and Participants, higher quality data and real-time access to information.


Rohit Kadam

Latest:

AI/ML Approaches to Assisted Medical Writing—Part 2

Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.



Tamie Joeckel

Latest:

Best Practices in Managing CGT From Protocol Design to Data Management

Though the fields of immunotherapy and cell and gene therapies have seen significant growth since April 2012, CGT clinical research remains a challenge.



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