Are Clinical Trials safe?
Clinical trials are conducted in a healthcare setting, usually in
a hospital or clinic, and are monitored by trained healthcare
professionals. An Institutional Review Board (IRB) approves all
clinical trials. This is a committee comprised of medical,
scientific, and non-scientific members. It is their responsibility
to ensure the protection of the rights, safety, and well-being of
human subjects participating in a trial. Trials are also reviewed
by the
FDA
.
Your physician oversees your well-being and would be good to
consult with regarding your possible participation in a trial.
(If the patient is willing, most trial centers are interested in
involving the patient’s regular physician. It isn’t reasonable to
involve outside physicians in the intricate day to day details of
the trial, but it is good practice to at least send a copy of the
informed consent for his review. Also release of information
forms, signed by the patient, will allow both parties access to
medical records. This will further ensure the patient’s safety
and well-being)
Do I have to stay overnight?
Some treatments of clinical trials require a patient to stay
overnight on an “inpatient” basis. For these treatments, you will
need to be admitted to the hospital. Other treatments can be
administered on an “outpatient” basis. This means that you will
not stay over in the hospital or clinic but will go home when your
treatment is done. The members of the treatment team will discuss
with you whether your treatment involves an overnight stay.
Will my records remain private?
The FDA understands the need to protect the privacy of research
subjects. Study records need not identify subjects by name but
they do need to provide some type of identifier to permit cross
indexing a subject’s study record. Identifying information must be
available to respond to allegations that may arise, such as the
claim that a subject’s consent was not obtained, or that the study
records do not represent actual studies or do not present the
actual results. When an individually identifiable medical record
is copied and reviewed by the Agency,
FDA
safeguards the
information and uses or disseminates the information only under
conditions that protect the individual’s privacy to the fullest
possible extent consistent with laws relating to public disclosure
and the Agency’s law enforcement responsibilities.
Research subjects’ expectations concerning confidentiality will
vary depending upon the study and the subject’s relationship to
the clinical investigator. Because
FDA
oversight responsibilities
may compromise subject confidentiality, the Agency requires
consent documents to note that FDA may inspect the records and
to describe the extent to which confidentiality will be maintained
by
the investigator. The subjects must be informed if anyone other
than authorized hospital or office personnel will have access to
records containing their identities. Although
FDA
regulations
neither require nor prohibit sponsor access to study records,
subjects must be made aware of the extent to which such access
will be allowed.
When clinical investigators conduct a study for submission to
FDA
, they agree to allow FDA access to the study records. The
investigator is responsible for making subject’s records available
to FDA for inspection and copying. The Agency will inspect and
copy records regardless of whether or not the subject has agreed
to such review.
What happens upon completion of the trial?
When a clinical trial ends, several things may happen. For some
chronic illnesses, a pharmaceutical company may continue to
provide the study medication to those who are responding well.
On some occasions you may stop receiving the investigational
medication. In this case, you may have to wait for the drug to
become available to the public.
After a study is complete, all of the information is collected and
analyzed. This information determines whether a study drug is
effective, whether it is safe and whether it has any side effects.
FDA medical advisors and specialists closely review this data
before approving any new drug.
Even after a drug is approved, pharmaceutical companies will
continue to conduct studies that compare the new drug to other
drugs already on the market. They are looking at comparisons
involving safety, effectiveness and cost. Other studies may
determine if a therapy can be administered to children or special
populations.)
After our patients complete a clinical trial, they will be
scheduled to return to the clinic for follow-up treatment. It is
our policy to see them for at least three visits. These visits may
include medication monitoring and/or individual counseling
however, this will be dependent upon the needs of the individual.
During these aftercare visits our investigators will determine the
needs of these individuals on a case by case basis. If the
investigator feels it is necessary for further referral, then it
will be provided. Regardless of the case, it is our goal to
provide each patient with continuity of care.
What if my condition doesn’t improve?
Although most of the newer medications show good efficacy with
fewer side effects, not all patients will experience an
improvement in their condition. However, we can assure our
patients that they will receive very closely monitored one-on-one
care. In the initial phase of a clinical trial, visits are usually
on a weekly and sometimes daily basis. During this time the
patient’s progress is closely supervised. If the patient’s
condition has not improved or has deteriorated after a reasonable
amount of time on treatment, then the Principal Investigator will
opt to discontinue the patient from the study and seek alternative
treatment. Also, patients may discontinue their participation at
any time during the study.
To find additional information regarding clinical research, the
U.S. Department of Health and Human Services publishes a booklet
called “What Are Clinical Trials All About?” This booklet provides
detailed information for a patient considering participating in
a
clinical trial.
