Main actors of a clinical trial

Different people interact during a clinical trial, they all have different roles, but of course depending on the firm or the exact field you work in it might change… It wouln’t be fun if it was simple!!

So here are the main actors and their roles in general.

 The project leader:

He is the one who leads the whole team, the manager. The project leader is involved early in the product life.
He writes the mains documents used for the clinical trial : the plan, the protocol, the report.
He is in charged of finding the sites where the study will be done.
He also has to maintain the budget, the timelines, and to succeed with the study! Sounds easy, doesn’t it?

The Clinical Research Associate:
The Clinical Research Associate, or CRA, is in charge of the good progress of the study.
He sets everything up in each clinical trial site involved in the study, explains to the hospital team what they will have to do, all the details of the protocol and so on.
After the study has begun, he comes regularly to check if everything is done following the protocol, and if this is not the case, he has to make what is necessary to correct it.

The Data Manager Associate:

The Data Manager is in charge of the data processing, verify and freeze the database (a frozen database can’t be modified, by anyone).

The Biostatistician:
The biostatistician does the statistical analysis required in the protocol on the frozen database.

 The investigator:
Most of the time, the investigator is a doctor. He is selected by the project leader to conduct the study in his hospital. He is responsible for including patients and for their follow-up.
Of course he is not doing this just for fun, he signs a contract and his hospital receives money!

The pharmacist:
The pharmacist, is most of the time the hospital ‘s one, stores the drug and deliver it to the patients. He also gets the empty (or not) boxes back to evaluate the compliance of patients. For example: when a patient gives back the previous month drug box if he had taken all the drug, it should be empty. If it is not you will know how many times he did not take his medication, 25% of the time, 50% ? (you wonder why? Well if a patient takes his medication every other day, no wonder why it doesn’t work!!)

There are a lot of other people playing a role in a clinical trial, and some of those I present will have a different job description depending on where they work but this will give you an idea of what kind of people are part of the clinical trial team J