Phase 1 Clinical trials are course of action to test new methods of treating, diagnosing or preventing health conditions of the patients. The goal is to govern whether the drug going to publicize are safe and effective with minimal or no adverse effect. Variety of things evaluated through clinical trials like medications, medication combinations and medical devices.
Phase I studies of a new drug are regularly the first that include people. Phase I studies are done to find the maximum dose of the new treatment that can be given safely without affecting severe side effects. Although the treatment has been verified in lab and animal studies, the side effects in people can’t be identified for sure. These studies also benefit to resolve on the best way to give the new treatment.
Key Points of Phase 1 Clinical Trials:-
• In phase 1 clinical trials researchers aim to find best dose of the drug with minimal side effects, tested on small group of 15-30 patients.
• It starts by giving very low doses of the drug to few patients and higher doses to the other patients until side effects become severe or acceptable effect is seen of the dosed drug.
• The main thing in lime light in phase 1 clinical trial is to observe how the drug effects the body and what acceptance of drug to the body.
• Placebos (sham or inactive treatments) is not part of phase I trials.
• These studies generally include a minor number of people (typically up to a few dozen).
• Often, people with different types of cancer can take portion in the similar phase I study.
• These studies are frequently done in major cancer centres.
• These studies are not planned to find out if the new treatment workings against cancer.
Observer keeps very close eye on the people as the main concern is the safety and to watch for any serious side effects because in phase 1 studies rare side effects may not be seen until late. These studies generally done in major cancer centres and people with different types of cancer can take part in the same phase 1 study.
Overall, phase I trials are the ones with the likely greater risk. But phase I studies help some patients with life-threatening illnesses.
