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The AI model that is changing clinical trial design

Drug Target Review

Clinical trials are expensive, slow and often limited by outdated design constraints. These digital twins are created for each trial participant using their baseline data – regardless of whether they are assigned to the placebo or treatment arm – and simulate how that individual would have responded under control conditions.

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Managing CGT trials: the role of IRT from discovery to clinical development

Drug Target Review

The journey of cell and gene therapies from preclinical discovery to clinical trials is complex and challenging, impacting every team member involved, from researchers in the lab to patients receiving treatment. These digital platforms are designed to manage and automate critical trial processes, especially related to drug management.

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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

FDA
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The Ultimate Guide to CRF Annotation in Clinical Trials

Quanticate

Clinical trials rely on comprehensive data collection to prove the investigational drug/device’s efficacy and safety, the Case Report Form (CRF), a structured document designed to record all trial-related data for each participant makes this possible.

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ICH E6(R3) Guidance: Why Clinical Trial Teams Need More Than Just a Process Update

Quanticate

This Step 4 document is the version recommended for regulatory adoption across all ICH member regions. This article is based on the final, Step 4 version of the ICH E6(R3) Good Clinical Practice guidance, officially adopted on 6 January 2025 by the International Council for Harmonisation.

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From lab to clinic: the rise of Radio-DARPins in oncology

Drug Target Review

With investigational new drug (IND)-enabling studies now complete, Orano Med is preparing to submit a filing to the US Food and Drug Administration (FDA) and is aiming to initiate clinical trials later this year. We have observed tumour-to-kidney ratios above two in biodistribution and a good safety profile.

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Pharmacognosy and Drug Patents: Unveiling Nature’s Medicinal Treasures

Drug Patent Watch

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This includes: Preclinical studies Clinical trials Regulatory approval Manufacturing and marketing Throughout this process, pharmaceutical companies seek to protect their investments through patents.