Clinical Research Info

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