These vary depending on the design of the study ... in budget will be approved at the time written approval is provided. Mid-study change of monitor and/or of clinical research organization ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review ...

Animal study data and toxicity data Manufacturing information Clinical protocols (study plans) for studies to be conducted Data from any prior human research Information about the investigator Due to ...

In the world of drug development, the timing and design of clinical trials can be crucial in getting a new drug to market ...

In a new study published in Lupus Science & Medicine, researchers reviewed randomized clinical trials (RCTs) to assess therapies for initial management of lupus nephritis (LN), focusing on their ...

Ledford, PhD, professor and vice chair of research in the Department of Family and Community Medicine, and Samantha Jones, PhD, assistant professor, the “Co-Creating Novel, Feasible, and Inclusive ...

The impact is severe. Nearly two million Americans live with PLD, with 72% reporting poor or fair health—compared to just 13% ...

The VISIBLE trial revolutionizes psoriasis research with strategies boosting diversity and rapid enrollment, addressing gaps ...