By their very nature, clinical trials carry a certain amount of risk. This risk varies from trial to trial. Prospective participants should ask as many questions as possible about the potential risks of any clinical trial. At the very minimum, participants should inquire about the following aspects of a clinical trial.
About Informed Consent
An informed consent document is not the same as a contract. Informed consent documents detail the risks of a particular research protocol. The purpose of an informed consent document is to help prospective participants understand the key parts of a clinical trial. These documents outline the requisite procedures of a clinical trial, the trial’s expected duration and the purpose of the clinical trial.
Participants must be fully informed before agreeing to join any clinical trial. By law, research coordinators must translate informed consent documents if a participant’s native language is not English. Also, informed consent is an ongoing process as physicians begin to discover more details of the potential risks and benefits of continuing a clinical trial.
Specifically, some clinical trials may cause adverse reactions and unpleasant side effects. Informed consent documents give potential participants a means to weigh the risks versus the benefits of joining a clinical trial. Prospective participants should think of informed consent documents as the beginning of a dialogue between researchers and those who join a study.
About Adverse Reactions
When testing a new drug, for example, adverse reactions may occur. These side effects can range from mild discomfort to life-threatening situations. Informed consent documents help prospective participants understand the likelihood of experiencing adverse reactions to the best ability of the clinical research team.
As researchers discover more information on the potential and severity of adverse reactions, participants will be informed as soon as possible. It is unethical and illegal for clinical trials to place participants at risk without informing them of the possibility of severe adverse reactions.
Often, patients experience little or no side effects at all after joining a clinical trial. Mild side effects may include headaches, indigestion or nausea in some cases. In the worst case scenario, severe side effects can require additional medical care or hospitalization. To minimize the risk of severe adverse reactions, participants and researchers must maintain a close relationship to remain vigilant against serious side effects.
About Time Commitments
Participating in a clinical trial may require a long-term commitment depending upon the protocol of the study. Informed consent documents outline the duration of the clinical trial, so prospective participants can decide whether or not the time commitment is acceptable.
For instance, some clinical trials may last as long as a few days, but some studies may last for months and require numerous laboratory tests. Informed consent means that both researcher and participant remain true to the study’s protocol. Contrary to popular belief, participants can discontinue a clinical trial at any time because an informed consent document is not a contractual obligation.
If prospective participants require more information on our Columbus, Ohio clinical trials, our facility is open 8 a.m. to 5 p.m. Monday – Friday. Those interested in our studies can also contact us via telephone, fax or email to ask any questions about our open clinical trials.
Clinical trials are beneficial to all parties involved (i.e. participants, physicians, sponsors, etc.). Without clinical trials, medical science cannot progress. Clinical trials test new ways to diagnose, treat and prevent medical conditions to shed light on health problems.
Benefits to Participants
By joining a clinical trial at Optimed Research in Columbus, Ohio, participants have the opportunity to help advance medical science. Treatment trials may potentially give participants access to medicines that are not yet available to the general public.
Another positive aspect of joining a clinical trial is access to medical specialists. The sponsors of clinical trials take great care to select a trustworthy team of medical experts when sponsoring a clinical trial. Working together, physicians and participants can help advance medical science in unforeseen ways.
Joining a clinical trial opens up opportunities for all patients stricken with a particular medical condition. Participants interested in helping others like themselves can take solace in knowing that by joining a clinical trial others will benefit in the future.
Benefits to Physicians
Physicians also benefit from participating in a clinical trial. By conducting a clinical trial, doctors can gain a more thorough understanding of the most forward theories and treatments for a particular health condition. All doctors have the best interest of their patients in mind. So by being a part of a clinical trial, doctors can place themselves at the forefront of medical science to help as many people as possible responsibly.
Benefits to Sponsors
Sponsors are able to develop new drugs and other treatment interventions as more hard data become available from clinical trials. Without clinical trials, sponsors would not be able to advance medical science either. By working closely with doctors and participants, sponsors can find the best way to move clinical trials forward in a responsible manner for the benefit of all parties involved.
Every clinical trial carries a certain amount of risk. To better understand the specific risks of joining a clinical trial at Optimed Research in Columbus, Ohio, prospective participants are welcome to contact us 8 a.m. to 5 p.m. Monday – Friday, and our team of professionals will answer any questions regarding the risks and benefits of our Columbus, Ohio clinical trials.