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FAQ

For individuals unfamiliar with the process, clinical trials may raise numerous inquiries.

The Atlas model places a strong emphasis on making our procedures and trials as accessible and understandable as possible for our patients. We recognize that you might have questions about our processes, protocols, and the advantages of joining our trials. Therefore, we offer potential participants a variety of concise and detailed responses to frequently asked questions about clinical research. Our goal is to answer as many of these questions as we can, but should you not find the information you seek, please don’t hesitate to contact our dedicated support team, who are always prepared to help you.

Who may participate in clinical trials?

A participant in a clinical trial must meet the study’s eligibility requirements and live in the Greater Rochester region. Some research projects seek volunteers with diseases or ailments to study in clinical trials, whilst others want healthy subjects. All clinical studies have participation guidelines. The use of criteria for each unique study is an important tenet of medical research that aids in the production of dependable results.

These criteria rely on elements like:
  • Age
  • Gender
  • Disease type and stage.
  • Past treatment history
  • Other medical conditions
It is vital to highlight that the criteria are not used to reject people on an individual basis. Instead, the criteria are utilized to choose suitable participants and keep them secure. All factors assist to guarantee that researchers can answer the questions they intend to learn.
What exactly happens during a clinical trial?
The clinical trial procedure varies depending on the type of experiment being undertaken. The clinical trial team consists of doctors, nurses, and other health care experts. They assess the participant’s health before the start of the study, provide precise instructions for participation in the experiment, closely follow the subject during the trial, and keep in touch after the trial is done. Some clinical studies need more testing and medical visits than a participant would typically receive for an ailment or condition. For all types of studies, participants collaborate with the research team. Clinical trial participation is most successful when the protocol is strictly followed and there is regular interaction with the research team.
What advantages and disadvantages come with taking part in a clinical trial?

Eligible volunteers can benefit most from well-designed and conducted clinical studies by:

  • Take an active part in their medical treatment.
  • Get access to novel research therapies before they are generally released.
  • Contribute to medical research to help others.

Clinical trial hazards include:

  • Therapy may have unfavorable, dangerous, or even deadly adverse effects.
  • The individual may not benefit from the treatment.
  • Compared to a non-protocol therapy, the protocol could involve more time and effort from them, such as visits to the research site, additional treatments, hospital stays, or complicated dose requirements.

Informed consent is a process designed to ensure that individuals fully understand the essential details of a clinical trial before choosing to participate. This process continues throughout the trial, providing participants with ongoing information. To assist someone in deciding whether to join the study, the doctors and nurses involved explain the study’s specifics. The research team then presents an informed consent form, which outlines important aspects such as the study’s purpose, duration, required procedures, and key contacts. The risks and potential benefits are also detailed in this document. The participant can then choose whether to sign the form. It’s important to note that informed consent is not a binding contract, and participants can withdraw from the trial at any time.

What are the possible negative outcomes and adverse responses?
Undesired actions or effects of a drug or treatment are known as side effects. Every potential side effect is listed in the informed consent document, which is examined prior to the start of the study. Possible side effects can encompass headaches, nausea, hair loss, skin irritation, or other physical issues which may differ depending on the specific medication being researched. Both short-term and long-term side effects of experimental treatments need to be assessed.
What factors should individuals take into account before taking part in a clinical study?

Individuals should have a thorough understanding of the clinical trial and should not hesitate to inquire about it with healthcare providers, including details on care, expectations, and expenses.

The participant may find the following questions useful when talking to the healthcare team. The informed consent document contains answers to some of these questions.

What is the aim of the research?

Who will participate in the research?

What is the reason researchers have faith in the potential effectiveness of the new treatment under evaluation? Has it undergone testing previously?

What types of examinations and therapies are included?

How do the risks, side effects, and benefits of the study stack up against those of my current treatment?

In what way could this experiment impact my day-to-day existence?

What is the estimated duration of the trial?

Is hospitalization necessary?

Who is responsible for covering the cost of the treatment?

Will I receive compensation for additional costs?

What kind of ongoing care is included in this research for the long term?

How can I determine if the treatment is effective? Am I going to receive the outcomes of the experiments?

Who will be responsible for my treatment?

What steps should a potential participant take before meeting with the research coordinator or doctor?

Each clinical trial conducted in the United States requires authorization and oversight from an Institutional Review Board (IRB) to minimize risks and ensure the benefits outweigh any potential drawbacks. An IRB is a group of physicians, statisticians, community advocates, and others who guarantee the ethical conduct of a clinical trial and safeguard the rights of study participants. Every organization involved in biomedical research with human participants is required by federal law to have an Institutional Review Board (IRB) that must approve and monitor the research on a regular basis. Consider the following arrangements:

Create a plan and make a list of potential inquiries.

Request the presence of a friend or family member to provide support and listen to the answers to the questions.

Remember to bring a tape recorder to capture the conversation and listen to it again afterwards.

Is the participant still seeing their primary healthcare provider while participating in a clinical trial?
Agreed. Many clinical trials offer brief treatments for a specific illness or condition, but do not offer long-term or comprehensive primary care. Furthermore, collaborating with the research team allows the participant to verify that no other medications or treatments will interfere with the protocol, with the help of the healthcare provider.
Is it possible for a person to withdraw from a clinical trial once it has started?

Yes. A person can withdraw from a Clinical trial at any point. Upon opting out of the trial, the participant must inform the research team and provide an explanation for discontinuing participation in the study.

What is the source of ideas for clinical trials?
Researchers are typically the ones who generate ideas for clinical trials. Following tests in the laboratory and on animals, researchers advance the most successful treatments to clinical trials. Testing a new treatment in a trial provides a more detailed understanding of its potential risks and benefits.
What entities provide funding for clinical trials?
Various organizations or individuals, including doctors, medical facilities, foundations, volunteer groups, pharmaceutical and medical device companies, as well as federal agencies like the NIH, DOD, and VA, sponsor or fund clinical trials. Experiments can occur in different settings, including specialized clinical research facilities, hospitals, universities, doctors’ offices, or community clinics.
What does protocol mean?
The protocol serves as the research schedule for a clinical trial. The strategy is meticulously created to protect the well-being of the people involved and address particular research inquiries. A protocol outlines the eligibility criteria for participants, the timeline of tests, procedures, medications, and doses, as well as the duration of the research. During a clinical trial, individuals adhere to a protocol and are regularly monitored by the research team to assess the safety and effectiveness of their treatment.
What exactly is a placebo?
A placebo is a substance that contains no active ingredients and has no therapeutic benefits. During clinical trials, new treatments are frequently evaluated by comparing them to placebos in order to determine their effectiveness. In certain research studies, individuals in the control group may be given a placebo rather than a real medication or intervention.
What does the term control or control group refer to?

A control serves as a benchmark for assessing experimental observations. In numerous medical studies, a set of patients receives an experimental medication or therapy, while another set receives either a standard treatment or a placebo for the same condition.

What are the various types of clinical trials?
Clinical trials focus on assessing new treatments, drug combinations, and innovative surgical or radiation techniques. Prevention trials seek to discover better ways to prevent disease in individuals without prior conditions or to stop a disease from returning. These approaches may include medications, vaccines, dietary supplements, or lifestyle changes. Diagnostic trials aim to find more effective methods or tests for diagnosing specific illnesses or conditions. Testing trials determine the best ways to detect particular medical issues. Quality of life studies, also known as Supportive Care studies, explore strategies to improve comfort and enhance the quality of life for individuals managing chronic illnesses.

If you would like to learn more about clinical trials, please contact us or read our FAQ.

Mrs Pabitra Basantia

Recruitment Manager

As a patient recruitment manager at Atlas, my job involves creating and carrying out plans to efficiently find and sign up suitable patients for our research studies. This includes working with healthcare experts and groups that support patients, launching focused recruitment efforts, and enhancing the involvement of potential participants. My commitment is to make sure that qualified individuals are recruited on time and successfully. Should you have further inquiries about volunteering for a study, don’t hesitate to reach out to me. I appreciate you thinking about volunteering to help progress medical research.