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Research Benefits

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. 

Why Clinical Trials Are Important

Clinical trials are an important step in discovering new treatments for breast cancer and other diseases as well as new ways to detect, diagnose, and reduce the risk of disease... This uncertainty can make it hard to decide if you want to participate in clinical trial.

Reasons for Conducting Clinical Studies

In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:

  • Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition

  • Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.

  • Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition

  • Examining methods for identifying a condition or the risk factors for that condition

  • Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness

Participating in Clinical Studies

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It contains the following information:

  • The reason for conducting the study

  • Who may participate in the study (the eligibility criteria)

  • The number of participants needed

  • The schedule of tests, procedures, or drugs and their dosages

  • The length of the study

  • What information will be gathered about the participants

 

 

Considerations for Participation

Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.

Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Most trials involve some risk of harm or injury to the participant, although it may not be greater than the risks related to routine medical care or disease progression. (For trials approved by IRBs, the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.) Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These requirements will be described in the informed consent document. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.