Types of Clinical Research Studies
The sponsor is the company that is requesting the drug trial. You will hear this term a lot while your signing up and doing a study. Don’t get this confused with the company conducting the clinical study. For the most part, the sponsor is a pharmaceutical company that is developing an investigational drug. There are non pharmaceutical companies that sponsor trials as well. You’ll see the majors like Pfizer, Glaxo-Smith-Kline, Bristol-Myers-Squibb, Astra Zeneca and so on. You also see smaller companies you’ve never heard of and everything in-between.
The sponsor makes all of the final decisions during the study. They can change or cancel the study at anytime, for any reason. The sponsors will not know who you are except by your medical information. Study participants are generally given a number or their initials are used as identifying information.
Every aspect of the study is predetermined by the sponsor. This includes the lab values for blood, diet consumed, visitation, whether or not subjects can go outside and many other conditions.
Representatives of the sponsor are usually present during the first dosing and may come in at various times throughout the study. They do not speak to subjects, only research staff. Due to confidentiality and for the validity of the study results, is not appropriate to carry on any conversation about the study with the sponsor unless they speak to you.
Some pharmaceutical companies such as Pfizer, Abbott and Bristol-Myers-Squibb (BMS) have their own “in-house” clinics but they still out-source a portion of their studies to research clinics.