Ark Clinical Research
Here are some of the more frequently asked questions we receive. If you have a different question or want more information, please email us at firstname.lastname@example.org.
Q: What is a clinical study?
A: Clinical studies are conducted to test new therapies for safety, effectiveness, and tolerability. Before a drug, medical device, or surgical procedure can be prescribed or performed on patients, it must go through multiple phases of testing.
Clinical trials adhere to a strict set of ethical, legal codes and regulations to protect the safety and rights of all volunteers. These codes and regulations are set and enforced by an Institutional Review Board (IRB), Food and Drug Administration (FDA), and Office for Human Research Protection (OHRP).
Q: Who can participate in a clinical trial?
A: All clinical trials have a set of guidelines about who can participate. This is called inclusion/exclusion criteria. These guidelines can be based on age, gender, medical and medication history, and existing medical condition(s). The inclusion/exclusion criteria are set to ensure that participants are a good fit. All research volunteers must be able to qualify in order to participate in a study.
Q: What are the risks and benefits of participating in a clinical trial?
A: When testing an investigational product, researchers want to make sure that the drug, device, surgical procedure, etc. is safe. Safety evaluations are conducted throughout the research process based on whether there were any side effects experienced with the product. Researchers want to rule out and make sure that no other factors are coinciding with dose response.
Clinical trials can be beneficial to the participant for various reasons and ways. If you are a healthy volunteer, you’re directly helping the researchers find newer and better treatments for illnesses that can be debilitating and life threatening. You’re indirectly helping those of the future that may be impacted by the same illness(es) being looked into today. Clinical studies are another avenue and may be the last option for those afflicted with chronic conditions where no other treatment is available. For those with ailment and participating in research, these trials could help improve your overall quality of life.
Q: What are my responsibilities as a research participant?
A: Every study has different requirements and restrictions to adhere while being an active participant. These parameters are set for your safety and well-being. Subject compliance is key to complete data collection, ensuring accurate results, and your cooperation makes all the difference.
It is also very important to make your study visit appointments on time. Certain visits can and will be time sensitive so it is imperative that you follow the study team’s instructions closely. Promptness is part of the overall compliance we factor in and your reliability as a research participant.
Q: What are my rights as a research participant?
A: Please know that study participation is voluntary. You can withdraw your decision to participate at any point during the study. No one should ever coerce, impose, or force you to be in a study. It is your choice to make after being fully informed about the study facts, which include: Purpose of the study, study design and objectives, what your participation will entail, the study benefits and risks, key study contact information, study compensation, and what to do in an emergency. You can find this information in the informed consent form. You should be given ample time and opportunity to ask questions, address your concerns to the provider and study team at any point. You will also be informed of any new information that may impact your safety, or ability to participate.
Regulatory bodies such as the Institutional Review Board, FDA, and OHRP ensure that your rights are enforced and preserved. These committees and organizations exist for your safety and well-being.
Q: Do research participants get paid?
A: You may be compensated for your time spent participating in the study and travel; however, we find that payment is not the motivating factor in participating in our studies. Our volunteers participate because they want to make a difference and/or they appreciate the consistent monitoring and extra care they receive for their condition. While we want to make sure your participation does not “put you out" or inconvenience your family budget, the pay you receive may not substantiate reasons to participate. Put simply, participation should not be seen as a “second job".
Keep in mind, whether you are compensated or not, studies conducted here at Ark Clinical Research are at no cost to you or your insurance.
Q: What happens after my study participation ends?
A: Upon completion of the participant’s last visit, all study data is verified for completeness and accuracy. Study data is submitted to the Sponsor for analysis. This is where safety, tolerability, and effectiveness are closely evaluated quantitatively and qualitatively. Depending on the results of the study, scientists will determine the next steps for testing. If the researchers think that these results are medically important, they may decide to submit data to journals, or to others in their field for further review.
Clinical testing results are also shared with government agencies who oversee and approve investigational products/therapies to market. Once a new drug, device, or surgical procedure is approved, it may become the next standard of care.
Q: What is an EUA?