Add to ORKGOversights in the design and conduct of phase I trials have resulted in morbidity and mortality1,2. Empirical evidence to improve regulatory review of phase I trials is lacking. We studied the characteristics of phase I trials, frequency of harms, and dissemination of results
Purpose: Alternatives to the standard design for con-ducting phase I trials are proposed with increa...
International audienceIntroduction: This study aimed at exploring adverse events (AEs) reporting in ...
International audienceAimsFollowing the serious adverse events that occurred in January 2016 during ...
Drug development is ideally a logical sequence in which information from small early studies (Phase ...
Emanuel and colleagues’ meta-analysis found that phase I studies are very safe.1 However, the accomp...
Most proposals to modify phase I trial designs address one of several issues: patient safety, patien...
Phase I trials use a small number of patients to define a maximum tolerated dose (MTD) and the safet...
Background: The primary goal of phase I studies is to effi-ciently and accurately determine the reco...
Objective: Phase IV trials are often used to investigate drug safety after approval. However, little...
Phase I clinical trials, the first studies in humans of a new anticancer agent or a new anticancer t...
In March 2006 a first-in-man trial took place using healthy volunteers involving the use of monoclo...
An efficient phase I trial is a crucial step in developing a new drug in a safe and timely manner. T...
Phase IV studies are conducted in real-life conditions to expand the knowledge on the efficacy and s...
Phase II clinical trials of experimental treatments play an essential role in drug development. Hist...
International audienceBACKGROUND: Determination of drug safety and tolerability is usually based on ...
Purpose: Alternatives to the standard design for con-ducting phase I trials are proposed with increa...
International audienceIntroduction: This study aimed at exploring adverse events (AEs) reporting in ...
International audienceAimsFollowing the serious adverse events that occurred in January 2016 during ...
Drug development is ideally a logical sequence in which information from small early studies (Phase ...
Emanuel and colleagues’ meta-analysis found that phase I studies are very safe.1 However, the accomp...
Most proposals to modify phase I trial designs address one of several issues: patient safety, patien...
Phase I trials use a small number of patients to define a maximum tolerated dose (MTD) and the safet...
Background: The primary goal of phase I studies is to effi-ciently and accurately determine the reco...
Objective: Phase IV trials are often used to investigate drug safety after approval. However, little...
Phase I clinical trials, the first studies in humans of a new anticancer agent or a new anticancer t...
In March 2006 a first-in-man trial took place using healthy volunteers involving the use of monoclo...
An efficient phase I trial is a crucial step in developing a new drug in a safe and timely manner. T...
Phase IV studies are conducted in real-life conditions to expand the knowledge on the efficacy and s...
Phase II clinical trials of experimental treatments play an essential role in drug development. Hist...
International audienceBACKGROUND: Determination of drug safety and tolerability is usually based on ...
Purpose: Alternatives to the standard design for con-ducting phase I trials are proposed with increa...
International audienceIntroduction: This study aimed at exploring adverse events (AEs) reporting in ...
International audienceAimsFollowing the serious adverse events that occurred in January 2016 during ...