ADVERSE EVENTS
Should all clinical trials be halted because of a lone adverse event incedent...mind you not SERIOUS in nature?
What is the usefullness of documenting an adverse event in designing future clinicals?
Does an adverse event ever point out subpopulations suggesting contraindications?
Does a product ever make it to market with adverse events? Serious Adverse events?
Does the Birth Control Pill exhibit adverse events? How many? How serious? Should it be on the market?
Viagra?
Is 2 incidents low or unusually high?
Is the degree here considered serious?
What is the adversity?
What should be done?
Should the FDA halt trials?
The nature of clinical trials is discovery. Adverse events are typical/commonplace. Serious Adverse Events would obviously be a concern. Still not necessarily grounds for halting clinical trials but it has happened.
Again the understanding behind the discovery of an adverse event is informational & it facilitates in the design of successful clinical trials. A high incedence of adverse events with progression would be cause for concern. A low level without progression is very positive indeed.
For those curious about clinical trials & adverse events see:
journals.uchicago.edu
devicelink.com
amcp.org
dcri.duke.edu
click on the open window at this web site:
cc.nih.gov
Terms:
Definitions:
1. "Adverse Event"
ΠAny undesirable experience concerning the health of a
participant occurring during human research whether or not it is considered
related to the study intervention:
a. new onset after start of study intervention
b. worsening after start of study intervention
i. increase in severity
ii. increase in frequency
2. "Serious Adverse Event"
ΠAny adverse event occurring at any dose that
results in any of the following outcomes:
a. death
b. a life-threatening adverse event (i.e., In the view of the Investigator,
the subject was at immediate risk of death from the reaction as it
occurred)
c. a persistent or significant disability or incapacity
d. inpatient hospitalization or prolongation of existing hospitalization
e. a congenital anomaly or birth defect
f. a medical or surgical intervention is required to prevent any of the
outcomes listed in a-e, which in the judgment of the Investigator
would not have otherwise occurred
usc.edu .pdf
fda.gov
CASE studies with Significant numbers of Serious Adverse Events yet gaining FDA approval:
Herceptin:
devicelink.com
"The most serious adverse event in the pivotal trial was cardiac dysfunction (NYHA Grade I-IV), which occurred more frequently when Herceptin was administered with anthracycline and cyclophosphamide (28 percent) compared with anthracycline and cyclophosphamide alone (7 percent), or with Herceptin plus paclitaxel (11 percent) compared to paclitaxel alone (1 percent). Although the NYHA Grade III/IV toxicity, which occurred in a smaller percentage of patients, was potentially severe and/or life threatening, signs and symptoms improved in 75 percent of patients."
Valtrex {Herpes Zoster and Genital Herpes }:
pharmacynetworkgroup.com
"The following events have been identified during post-approval use of VALTREX in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, causal connection to VALTREX, or a combination of these factors."
Ziagen { HIV }:
"In clinical trials to date, the most commonly reported adverse events were headache, nausea, vomiting, malaise and diarrhea when Ziagen was taken, primarily with Epivir and Retrovir but also with all marketed and most investigational compounds. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir and other antiretrovirals."
BIRTH CONTROL PILLS: The New Patch...
ortho-mcneil.com
"The contraceptive patch contains hormones similar to those in birth control pills. Hormonal contraceptives are not for everybody. Most side effects of the contraceptive patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke or heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use hormonal contraceptives are strongly advised not to smoke. Some women should not use the contraceptive patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant."
contraceptiononline.org
Side effects with the new oral contraceptive are similar to other OC formulations. In the large European study, approximately 42% of women in both groups reported adverse events that investigators classified as possibly, probably, or definitely related to treatment. Side effects occurring in more than 1% of the study population included headache, breast discomfort, nausea, abdominal pain, and migraine.6 Other studies have reported depression and emotional ability as additional side effects of the new formulation
Flow Chart:
hsc.unm.edu
Jeff |
