Clinical drug trials are broken down into phases, with phase 1 signifying the first time a human is exposed to a drug. Phase 1 drug trials are generally conducted on healthy humans; however, in some cases, those who are suffering from the affliction the drug hopes to treat are included in the trials. Image CreditThese
Clinical drug trials are broken down into phases, with phase 1 signifying the first time a human is exposed to a drug. Phase 1 drug trials are generally conducted on healthy humans; however, in some cases, those who are suffering from the affliction the drug hopes to treat are included in the trials.
These trials usually take the form of separating test subjects into two groups, giving one set a placebo and the other the real drug. This is to determine the efficiency and side effects and to ensure that any medical issues that arise can be dealt with swiftly. The test subjects are under the supervision of doctors and nurses, who will be alerted if the participants experience any untoward changes.
The aim and objective of phase 1 trials
Adaptive phase 1 clinical studies are predominantly designed to test the tolerability and safety of a drug. The primary objectives are to find the maximum dosage that is effective and to determine the pharmacokinetic profile.
Safety is a major concern of all taking part, with organisations such as http://www.richmondpharmacology.com/specialist-services/adaptive-phase-i-studies keeping a close watch on participants and always being on hand should the need for medical intervention arise. In some cases, these trials are carried out in a hospital, but this is not always the case.
Dosage may be increased over time during phase 1 to ascertain what a patient’s tolerability level would be, but they are never overexposed or put at risk.
Phase 1a and 1b
Phase 1 trials can be broken down into phase 1a and phase 1b. In phase 1a, both the new drug and the placebo are administered to a group daily over the course of several weeks and their effects studied. In phase 1b, studies of the results of what occurred in phase 1a are conducted. The overall results of both stages of the phase play a crucial role in whether further trials are conducted.
Should the phase 1 results be unexpected or not what was desired, there may be deliberation as to whether to continue the trials or begin them again with a different dosage. The data gathered during this phase of the trial process is crucial to the future of a potential drug; in many cases, new drugs do not make it past this testing round.