Working in a Phase I trials unit
A few months ago I started working for a Phase I clinical trials unit as a medical officer/sub-investigator after 17 years in clinical practice.
What is a Phase I study ?
A Phase I study is usually a first-in-human study of a new experimental medication in healthy volunteers. There are a number of other types of phase I studies, but usually the drug is still in a very early developmental phase after laboratory and animal testing or there has been a change to an already approved medication that needs testing at starting level.
The information the study tries to obtain is usually about drug levels in the body, side effects and toxicities and s basic information on whether the drug does what it is designed to do.
All studies are approved by and ethics committee and meet a set on international standards and guidelines set out for how a trial should be run.
What does a sub-investigator do?
A sub-investigator in a Phase I unit has a number of duties at different stages of the Phase I trial.
Consenting and screening volunteers to participate in the trial involves talking to a volunteer about the study. This involves
- learning the study which usually includes the study protocol (50-100 pages), the Investigator’s Brochure (50-100 pages), the consent form (15-20 pages) and any other information such a pre-trial slides.
- Explaining the study in detail to the volunteer, going through the consent form together and answering all questions
- After a volunteer feels comfortable and has signed the consent for they are screened for medical problems and a range of other parameters to assess their safety and suitability for the study and whether they meet all the inclusion and exclusion criteria for the study.
Reviewing all testing such as blood and urine and ECGs to once again assess for medical conditions and whether the volunteer meets the criteria for the study.
Once the study is underway, the job involves checking-in the volunteer in to he unit and once again checking the various parameters and medical history for safety prior to dosing, being present at the time of dosing of the drug, monitoring during the study, check in out the volunteer and checking the volunteer at follow up time points.
At every stage the job involves a high degree of clinical acumen, high level communication skills and a keen eye for picking up medical problems in an otherwise “healthy volunteer”.
Every study has a Principal Investigator who oversees the study and is directly involved with decision making.