What Is a Clinical Trial?

May 13, 2009

What Is a Clinical Trial?

Clinical trials are research studies in which people help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.

Why are there clinical trials?

A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.

What are the different types of clinical trials?

Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer.

Screening trials test the best way to find cancer, especially in its early stages.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases:

* Phase I trials:

These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

* Phase II trials:

A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

* Phase III trials:

These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and cancer centers nationwide.

Source: National Cancer Institute


What is a clinical trial?

August 19, 2008

For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.

What is the difference between a clinical trials register and a clinical trials registry?

A clinical trials register is the formal record of an internationally agreed minimum amount of information about a clinical trial. This record is usually stored in and managed using a database.

A clinical trials registry is the entity that houses the register, and is responsible for ensuring the completeness and accuracy of the information it contains, and that the registered information is used to inform health care decision making. A clinical trials registry is more than its database.

Source: WHO

You can also refer complianceonline to see good webinar on clinical trials


A must training of individuals involved in carrying out research in human subjects

July 18, 2008

The US government is considering setting up a register of institutional review boards (IRBs) and asking for enhanced training of individuals involved in carrying out research in human subjects.

Reason behind training

The move follows a damning report on the US Food and Drug Administration’s oversight of clinical trials, published in September 2007 by Daniel Levinson, the inspector general of the Department of Health and Human Services (DHHS).

Among the deficiencies noted in the report were that the FDA did not have any clear picture of the number of trials being conducted in human subjects and low rates of clinical trial site auditing (less than 1 per cent). Of the estimated 350,000 trial sites the FDA was believed to have inspected 2,855.

What FDA Focus more during inspection is:

Moreover, when inspections did take place, they generally targeted completed trials and often focussed on verifying the quality of the data rather than human subject protection, according to the report.

What the US offices are looking for

  • Training
  • Educational programmes

Advantage

The implementation of such training and education programs might help to ensure that individuals involved in the conduct or review of human subjects research at institutions … understand and meet their regulatory responsibilities for protecting human subjects.