If you and your colleagues have developed a promising new drug or medical device, the next crucial step is to have an established firm that is experienced in clinical trials management to guide you through the regulatory labyrinth that must now be navigated. As monumental as an achievement as it is, it is not enough these days to simply create a product. You are to be congratulated. On average, approximately 1000 drugs are tested before one ever makes it to clinical trials. Now, it must be meticulously scrutinized during an exacting clinical process. To achieve the hoped-for positive results from these trials, the clinical trials management team will work with you through every step and every phase.
This is where you submit for approval the information about what you hope to achieve with your product, along with details about the research that has gone before. This step typically lasts 1 to 3 months.
During this phase, very small doses, below the therapeutic level are given to determine both the pharmacodynamics and the pharmacokinetics of the drug, i.e., what the drug does to the body and what the body does to the drug. This is done with an extremely small sample of people, usually no more than 10.
During this phase, the drug is tested for efficacy, starting with sub therapeutic doses that ascend, to test for dose ranging. The sample group is expanded, typically between 20 to 100 healthy volunteers.
At this point, the drug is not presumed to have any therapeutic value. An expanded sample of patients, usually between 100 to 300, is given actual therapeutic doses to check for efficacy.
Having passed through the previous phases, the drug is now presumed to have some effect. On an expanded sample of perhaps 1000 to 2000 patients, the drug is now administered in therapeutic doses to check for both efficacy and safety. One major difference between this phase and the previous ones is the results are looked at by both a clinical researcher and personal physicians, as well.
This is the postmarketing surveillance phase, where the drug is released to the general population, and anyone can seek a prescription with the approval of their own personal physician. To aid with this the Food and Drug Administration offers MedWatch, a service where physicians may voluntarily report any adverse reactions to medications suffered by their patients. The main goal of this phase is to monitor a drug's long-term effects.
Because these phases can easily take months, and even years, your clinical trials management team needs to have established relationships with qualified researchers, relationships with pharmaceutical companies, familiarity with FDA protocols (along with the protocols of the governing agencies of other countries), and a broad base of volunteers, across a range of conditions.