article thumbnail

Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. One major concern is its tendency to hallucinate, confidently producing factually incorrect information.

article thumbnail

The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

CDMO Selection: The Ultimate Checklist

Drug Patent Watch

It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. Range of Services The range of services offered by a CDMO is another vital criterion.

article thumbnail

Future-proofing drug development with GenAI

Drug Target Review

Leveraging the extensive breadth of available data to identify entities and relationships across data sources, clinical research experts, therapeutic specialists, machine learning (ML) engineers and others can collectively evaluate areas of interest that may create new opportunities for the asset and a broader clinical strategy.

article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

A COU statement will typically include detailed information about how the biomarker will be measured, the analytical method involved and will be supported by various performance characteristics along with the specific clinical context wherein the biomarker is intended for use.

article thumbnail

Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. DCEs typically produce population-level estimates and require large samples to be robust.

article thumbnail

The Role of Big Data in Clinical Trials

Quanticate

Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.