Authors


Matthew Satterthwaite

Latest:

How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and Retention

Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.



David Li, MD, PhD

Latest:

Initial Design Considerations for Immuno-Oncology Trials

Perspectives and insights regarding regulatory considerations when planning and conducting immunotherapy studies.


Dan DeBonis

Latest:

How Digital Technology and Remote Assessment Strategies Can Aid Clinical Trial Research

While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.


Jules Moritz

Latest:

When Trials Stumble, Mobile Research Nursing Lends a Helping Hand

With the assistance of mobile research nursing, in-home visits provide solid alternative to trial participants, especially during COVID-19.


Matt Latey

Latest:

Make Your Clinical Trial a Priority in a Busy Landscape

A more crowded space is presenting new challenges for stakeholders that must be addressed to improve efficiency.


Trinette Mitchell

Latest:

The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations

Tufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.


Alexandra Kalpadakis-Smith, PhD

Latest:

Properly Training Physicians in Dermatology Trials

Poor representation of dark skin tones in textbooks emphasizes need for change.


Kate Godwin-Smith

Latest:

Better Patient Engagement Begins With Electronic Informed Consent

While eConsent has become more widely adopted since COVID-19, work still needs to be done in improving patients’ understanding.


Evidera

Latest:

Addressing Challenges With Intelligent Point-of-Care Device Deployment

Key challenges and strategies to consider when developing devices intended for home-use or deployment in a clinical research setting.


Jill Platko

Latest:

The Importance of Simple Clinical Trial Diaries

Sponsors can simplify diaries by taking a closer look at the three common sources of complexity.


Libbi Rickenbacher

Latest:

Increased Digitization in Clinical Trials: Expectations for the Year Ahead

Top predictions for the major trends that will shape clinical trial design in 2022.


Pierre Etienne

Latest:

Just How ‘Real’ is Real-World Data?

Addressing sources of tension on differentiating types of data.


Brian O’Dwyer

Latest:

Self-collection of Blood Specimens in Clinical Trials

Operational and patient burden considerations for self-collection of blood specimens in clinical trials


Steve Sibley

Latest:

Simultaneous New Drug Submissions: Is it Possible?

A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.


Devendra Raj, PhD

Latest:

Global Regulatory Publishing Trends

A review of submission formats for drug development.



Richard Yeatman

Latest:

eSource Interoperability Between EHR and EDC

Evidence from a Phase III cancer trial points to notable advances in data-transfer tech.


Rakhi Kilaru

Latest:

Harnessing the Power of Scientific Surveillance

Statistical methods used via this technique in centralized monitoring.


Mabel Crescioni

Latest:

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?

Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.


Kelly FitzGerald, PhD, CIP

Latest:

Obtaining Informed Consent for Future Reuse of Patient Data

Best practices in data re-identification and control when designing future trials.


Narinder Chopra

Latest:

Understanding the Complexities of Diversifying Clinical Trials

Tufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.


Gretchen P. Jackson, MD, PhD

Latest:

Accelerating Clinical Trial Design and Operations

Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.


Sandra Smyth

Latest:

Towards Data-Driven Clinical Trial Planning and Strategy

Optimizing feasibility through increased data collection.


Meg Richards, PhD

Latest:

How Life Sciences Companies Can Strengthen Regulatory Submissions With External Control Arms

Data from past clinical trials has provided researchers with a good starting point to create more ECAs.


Tim Rich

Latest:

Decentralized Clinical Trials Bring Research to the Patient—in More Ways Than One

DCTs proving to solve numerous pain points for patients in clinical research.


Ashley George

Latest:

Virtual Clinical Trials Post-COVID-19: Collaboration Will Be Key to Success

The use of virtual trials will surge in the future and could become the de facto standard for clinical studies, says a recent Pistoia Alliance poll.


Anna Pinsky, MD, PhD

Latest:

The EU Regulations Catching US Pharma Companies Off Guard

Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.


Jeff Policastro

Latest:

Changing the Paradigm in AI Implementation

How pharma companies can reduce the risk of failure with AI-based innovations.


Warren Stacey

Latest:

Putting Labeling on the Boardroom Agenda

How smart packaging can aid clinical trial adherence.

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