About Research Studies


1. What are research studies?
2. Why are research studies done?
3. Where can people find out about research studies?
4. Why do people volunteer to be part of a clinical trial?
5. Where are research studies conducted?
6. What is “informed consent”?



1. What are research studies?


A research study is created to answer specific health questions. These questions may involve new treatments, new combinations of medicines, or new approaches to preventing and detecting disease.


Carefully conducted research studies are the safest and fastest way to find treatments that work in people, and new ways to improve health.


Research studies are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and the length of time for the study.


2. Why are research studies done?


Many research studies are done to see if a new drug or device is safe and effective for people to use. Some studies compare existing treatments to determine which is better. For most studies, researchers, doctors, and other health professionals administer the research studies according to strict rules set by your country’s regulatory agencies.


3. Where can people find out about research studies?


One way to find information about research studies is by searching this Website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is eligible to participate, locations, and phone numbers to call for more information.


4. Why do people volunteer to be part of a clinical trial?

 

·         Clinical trials are an important part of the research of new medicines.

·         Being in a clinical trial allows participants to play a more active role in their own healthcare.

·         Participants may be able to receive an investigational drug before it is widely available.


There are possible risks involved with any clinical trial. The doctor and study coordinator review these risks with potential participants before they agree to participate.  Study pparticipation is strictly voluntary and participants can decide to leave a trial at any time without penalty or explanation.


5. Where are research studies conducted?


Research studies can be sponsored by an organization such as a pharmaceutical company, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the studies, which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.


6. What is “informed consent”?


The government requires researchers to give prospective participants complete and accurate information about what will happen during the study. Participants must sign an "informed consent" form before joining the study, indicating they have been told that the study is research, and that they can leave the research study at any time. This informed consent helps ensure that a prospective research study participant understands what’s involved in the study.