BEING A SUBJECT FOR A CLINICAL RESEARCH..

It is important for you to talk to a physician, family member, or friends about your decision before
joining a trial. You should fully understand the trial's objective and the possible risks before making
your decision.

Clinical Research

Clinical research or trial is a research study to find out certain health information, such as new
treatments, using human volunteers. It may be conducted under controlled environments or in
natural settings.

All clinical researchs have guidelines to select human subjects-inclusion criteria. The criteria are
based on age, gender, the type and stage of a disease, previous treatment history etc. A participant
must qualify for the study before joining a clinical research.

There are different types of clinical research- treatment, prevention, diagnostic, screening and
quality of liffe (supportive care). The research team includes medical doctors, nurses and other
health care professionals. The research team provides an informed consent document to the
participants. The informed consent document usually contains details about the study, such as its
purpose, duration, required procedures and key contacts. This informed consent document also
explains risks and potential benefits. Informed consent is not a contract; participant can withdraw at
any time from the study. Hower, once the participants have signed the document, they are expected
to contact the research team frequently.

To protect the safety of the participant, the research study follows a carefully controlled protocol.
This protocol details what researchers will do in the study. As the clinical study is on-going,
researchers report the results at scientific meetings, journals and to various government agencies. In
addition, every clinical research or tril must be approved and monitored by an Institutional Review
Board (IRB) to ensure the risks are low. An IRB is an independent committee of physicians,
statisticians, community advocates and others.

Clinical research are divided into four phases. In Phase I trials, researchers test a new drug or
treatment in a small group of health subjects (human being) for the first time to evaluate its safety,
safe dosage range (linear portionality of dose and drug concentration) and identify side effects (if
possible). In Phase II trials, The study drug of treatment is given to a larger group of people
(100-300) to see if it is effective (response). In Phase III trials, the study drug or treatment is given to
large groups of patients to confirm its effectiveness. Please, read our
product development for
detials. In Phase IV trials, post marketing studies delineate additional information including the drug's
risks, benefits, and optimal use.


Double Bind Studies

This web-page provides information on double-bind studies. Why it is so important?

Resources

Clinical Cancer Research

American Association for Cancer Research

CenterWatch
Clinical Trials Listing Service.

Clinical Trials.gov
Information on Clinical Trials and Human Research Studies
Clinical Research Info