What are Phase 1b trials?

What are Phase 1b trials?

Phase 1b Clinical Trial means a clinical trial of a pharmaceutical product into infected patients with the primary purpose of determining safety, efficacy, metabolism, pharmacokinetic properties and clinical pharmacology of such product.

How do I find a medical trial?

Around the Nation and Worldwide To search for other diseases and conditions, you can visit ClinicalTrials.gov. This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.

Can anyone participate in a clinical trial?

Each study has its own rules about who can — or cannot — participate. This is called “eligibility.” Your eligibility may be based on your age, gender, overall health, type and stage of a disease, treatment history, and other conditions. Not everyone is chosen to participate.

What does Stage 3 trial mean?

A study that tests the safety and how well a new treatment works compared with a standard treatment. For example, phase III clinical trials may compare which group of patients has better survival rates or fewer side effects.

What is the difference between Phase 1a and 1b clinical trial?

Phase 1a will involve dose escalation to determine the maximum tolerated dose (MTD). The MTD will be determined on the basis of the results from the safety evaluation. Phase 1b will involve cohort expansion at one or more dose levels to determine the recommended Phase 2 dose.

What is a Phase 1b/2 trial?

A study that tests the safety, side effects, and best dose of a new treatment. Phase I/II clinical trials also test how well a certain type of cancer or other disease responds to a new treatment.

Who are not eligible for clinical trials?

Some trials only include people in a certain age group, or of one sex, or at a particular stage of their illness. The exclusion criteria state who cannot take part in the trial. For example, people who are already taking particular medicines may be excluded as these may affect the trial treatment.

What is Phase 2b clinical trial?

Phase 2b Clinical Trial means a study of a pharmaceutical product in human patients to determine efficacy and statistical trends prior to initiation of Phase 3 pivotal studies. These studies will also evaluate potential doses and dosing regimens to optimize the therapy under investigation.

How much does a patient pay for clinical trials?

Clinical trials generally pay between $50-$300 per day/visit, with compensation dependant upon the length of the time required as well as the procedures performed. Overnight stays typically pay more money than those involving repeat visits.

Who pays cost of clinical trials?

The sponsor of the study (such as the government, drug makers or technology companies) typically pays for all costs involved with a clinical research study. This includes supplying the new treatment, as well as any special testing, possible extra physician visits, and research costs involved in the clinical studies.

How long do clinical trials typically last?

It may take time for long-term side effects to appear, making this an important phase. Looking at the big picture, it takes approximately ten years for a new treatment to complete the journey from initial discovery to the marketplace. Clinical trials alone take six to seven years on average to complete.