Peer-Reviewed Articles

To Sign or Not to Sign FDA Form 1572?

By Natalia Buchneva

Exploring that pivotal question for clinical investigators, sponsors, and global CROs.

Does PI Certification Make a Difference?

By Kathryn Rena Hodges, PhD, Duane Akroyd, PhD

Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.

Monoclonal Antibodies: Clinical Pharmacology Knowledge in Support of FIH and Early Development

By Narine Baririan, Pharm. D

There are several pharmacokinetic factors and peculiarities that should be considered carefully when designing and running first-in-human (FIH) studies for monoclonal antibodies.

CISCRP Corner

Sharing Stories of Clinical Trial Participation from Start to Finish

How mapping patients’ health journeys can drive a deeper understanding of their experiences and motivations.

Patient Experiences with Clinical Trial Medicines and Instructions

Providing easy to understand and culturally appropriate investigational medication education and support can make all the difference in improving the patient experience.

Patient Perspectives on Seeing Trial Results

The third in a series of results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) landmark 2017 Perceptions & Insights Study.

ACT TV

Events

Rare Diseases & Orphan Products Breakthrough Summit

October 15 - 16, 2018
Marriot Wardman Park, Washington, D.C.

Basket and Umbrella Trials for Oncology

October 17 - 18, 2018
Philadelphia, PA

IRT 2018

October 22 - 23, 2018
Philadelphia, PA

Blogs

Quiz Time: What Methods Would You Use for HTA?

By Peter O'Donnell

Imagine you are in charge of European legislation on pharmaceuticals. Imagine you've been told to draft rules on how to conduct clinical assessments at European level to help measure the value of a medicine. What would you go for?

FDA Seeks Reliable Patient Information to Support Regulatory Decisions

By Jill Wechsler

As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers.

New Data Sharing Platform—DataCelerate—Aims to Improve Clinical Development

By Moe Alsumidaie

In this interview, Michael J. Graziano, PhD, DABT, Vice-President, Drug Safety Evaluation for Bristol-Myers Squibb and leader of the BioCelerate Toxicology Data Sharing Initiative, provides more details about the DataCelerate platform.

Noteworthy

Improved Understanding of Psoriasis Buoys Treatment Hopes for Patients

By Dr. Marlis Sarkany

Advances in our understanding of the genetic, immunological, and environmental factors that contribute to the pathogenesis of psoriasis have led to the development of very effective precision therapies that alleviate patient morbidity and improve quality of life, especially for patients with moderate to severe disease.

RBM: Barriers to Adoption

By Applied Clinical Trials Editors

The results of a 2018 survey of sponsor, CRO, and technology companies.

A Roadmap to Phase I Challenges for Cell and Gene Therapy Products

By Nicole Gallo, Jason Birri, Chris Kelly, Julie Kristen Hagan

Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.

eBooks

Clinical Trials for Rare Diseases

This eBook will focus on advancing research, drug development, and trial management in rare diseases. Articles cover considerations from virtual trials and eCOA to the case for highly-skilled CRAs.

View all eBooks

 

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