Path to Phase I
The first step of the process
what is Discovery and Development
IND
What is Investigational New Drug Application
Phase I Clinical Trials
Before joining a Phase I clinical trial, participants must sign this document, ensuring they understand the risks, even if compensation is offered.
Informed consent
The second step of the process
what is Preclinical research
finding molecules with activity at a target
what is hit identification?
Animals
Until the 1970s, 90% of clinical trials were carried out on this group of people who ended up there for some reason or another
What is prisoners?
Required for FDA approval
what is an IND
test the absorbtion, metabolism, distrubution, and retention
This meeting with FDA staff can answer questions and address concerns before they arise on the IND application (hint: it's a very simple name)
Pre-IND Meeting
This group is responsible for reviewing research protocols to make sure a clinical trial is ethically acceptable and safe for participants.
Institutional Review Board (IRB)
percent of drugs that pass step 1
what is 20%
done using antisense tech, gene knockouts, siRNA, or monoclonal antibodies
what is target validation?
If the FDA does not respond within this number of days after IND submission, the sponsor may begin clinical trials.
This percentage of patients in a systematic review of 475 clinical trials from 2008-2012 reported no drug-related adverse effects.
percent of drugs that pass phase I
what is 70%
information on manufacturing, personnel, record keeping, and quality control required by FDA
what is CGMP (current good manufaturing practice)?
This is the term for an IND that allows researchers—not industry sponsors—to conduct studies, often used in academic medical centers for investigator-initiated trials.
Investigator IND
Johns Hopkins was indirectly responsible for this woman's death due to an oversight in reviewing a drug called hexamethonium
Ellen Roche