Pre-clinical studies and clinical tests
The development of monoclonal antibodies and peptides as diagnostic or therapeutic agents involves several research stages, including preclinical studies and clinical trials.
Pre-clinical studies involve biochemical and biophysical characterization of antibodies and peptides, as well as functional assessment of their activity in in vitro and in vivo cell assays. These assays are performed on laboratory animals and their purpose is to document information on efficacy, safety and pharmacological characteristics that precede the conduct of human clinical tests.
Clinical tests evaluate safety and efficacy of antibodies in patients. Phase I clinical tests are characterized by being the first time a new drug is administered to humans. Therefore, all care is necessary. They are performed to obtain the first safety data from the experimental treatment in humans and to establish the dosage and recommended route of administration. Phase I clinical tests usually involve small numbers of participants (dozens) and are usually healthy volunteers. In Oncology however even in development Phase I, sick patients are recruited to participate. Phase II clinical tests begin to assess efficacy of a new drug and typically involve a greater number of patients (hundreds). In Oncology, the number of patients is usually lower. Phase III clinical tests are performed once a new drug has been proven to be minimally safe (in Phase I and II tests) and effective (in Phase II tests) and are performed in hundreds or even thousands of patients, with the objective of comparing the new treatment with available standard treatments.