Is It Safe to Participate in a Clinical Trial?
When people first consider the idea of participating in a clinical trial, their primary concern understandably involves safety of the research and avoiding any long-term bodily damage. As important and beneficial as clinical research is, it is critical to protect and ensure the safety of all participants. Our staff at the WVU CPRC will be monitoring participants throughout the process.
Participation in a clinical study, is it safe? One of the first concerns of someone who may be interested in participating in a clinical trial is if there will be any long-term bodily damage that may occur to them as a result. Although clinical research is very important and beneficial above all protecting and ensuring the safety of participants is the first and main concern of all researchers. At WVU CPRC the staff monitors participants throughout the entire process.
Early-stage drug trials. In a study recently released by The British Medical Journal it is indicated that, “Less than 1% of healthy patients enrolled in early-stage clinical trials experience serious adverse events, half of which are unrelated to the drug or procedure studied.” Researcher’s findings offer good support for the general safety of phase 1 trials. Lead author Ezekiel J. Emanuel, MD, PhD, clarifies that “some have claimed that these trials pose high risks of harm to participants. But these findings show such claims to be essentially without empirical validity.”
As a clinical researcher our top priority is participant safety. For clinical researchers participant safety is the first and main concern when conducting research. Medications are often tested for years to investigate for any potential side effects that may occur. According to the FDA, during phase 1 of clinical trials, “The goal is to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted.”
Side effects associated with the drug are identified quickly One detail that is not normally recognized by many people is that side effects, and serious side effects, are identified quickly after the participant begins to take the medication. Clinical investigators are highly trained doctors or designated individuals equipped to quickly identify and treat any side effects that may occur.
