Most people realize that a great deal of research takes place before a drug is approved for marketing. Few realize that residents of the South Coast may participate in this necessary testing.
Located in Dartmouth (MA), Northeast Medical Research Associates (NEMRA) conducts clinical studies in all phases of clinical research which are required by the FDA before a drug is approved for marketing. Before any study, the prospective new medication is evaluated in many animal studies which usually take several years to carry out.
“Prior to any of the procedures being performed in the study, the patients are required to read, sign and date an informed consent which outlines the conduct of the study and explains the potential risks and benefits to be derived from participation,” Dr. Paul Chervinsky said, adding “This would include any financial incentive which would be made.”
It is important to note that clinical personnel must explain the purpose and duration of the study as well as trial procedures involved. Participants always have the right to withdraw from a study at any time without penalty.
It also shouldn’t cost you to participate. Patients to not pay to participate in a study and all procedures and examinations along with the study medication are provided by the trial sponsor.
All studies of a drug are carried out under a protocol which has been approved by the FDA and an independent review board to insure safety and rationale. The protocol has to be strictly adhered to as the trials usually involve more than one site so all data collected can be combined in evaluating results of the study.
Next week’s blog will focus on the next stage of the clinical study process: Going Through Phases