Aavon Clinical Trials

Careers

FAQ

‘LEARN THE LINGO’ OF CLINICAL STUDIES

These are some common questions we hear from new patients. Call with your personal questions. Call – 713-282-5600.

Protocol

A protocol is the blueprint of a study. Each study has a protocol that plans out the trial step by step with the criteria clearly stated, including medical qualifications of who can and cannot join the study, the schedule of procedures and dosages, and the study length of time. It is designed to protect the health of all participants. The clinical staff follows the protocol to monitor the patients’ health, to determine the treatment’s safety/effectiveness, and to help answer any detailed research questions you may have regarding the study.

A clinical trial is a research study in which volunteers receive investigational medical products developed by pharmaceutical and biotechnology companies. Qualified physicians called Investigators, as well as other research professionals, are selected by the sponsoring companies to conduct these trials in order to determine the benefits of their investigational drugs.

Clinical trials are usually conducted in four phases—phase I, phase II, phase III and phase IV. A small number of people participate in phase I trials while the later phases encompass a larger number of volunteers.

There are guidelines that determine who can participate. First, a volunteer must qualify for the study. Criteria permitting volunteers to participate in a clinical trial are called “inclusion criteria.” Factors that disallow volunteers from participating are called “exclusion criteria.” Age, gender, the type and stage of a disease, previous treatment history, and other medical conditions are examples of such criteria.

Second, some clinical trials seek participants with specific illnesses or conditions to be studied. Others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participant safety, and ensure that researchers learn the information they need.

In a clinical trial, a volunteer is usually assigned to a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.

A placebo is an inactive product used to assess the experimental treatment’s effectiveness. The participant, physician and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteer during the study. Regardless of which treatment is received, however, the level of medical attention and respect that each participant receives is the same.

Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. They should also understand the credentials and experience of the staff and facility involved in conducting the study. Questions to ask a physician or medical caregiver:

  • How long will the trial last?
  • Where is the trial being conducted?
  • What treatments will be used and how?
  • What is the main purpose of the trial?
  • How will patient safety be monitored?
  • Are there any risks involved?
  • What are the possible benefits?
  • Do I have to pay for any part of the trial?

In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member. The participant’s health will continue to be monitored during and after the trial. A detailed description of what is expected of volunteers will be outlined in consent forms along with specific clinical trial information.

What is informed consent?

Prior to participating, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent, a process that can help you decide if participating in a trial is right for you.

When you give written consent to participate in a clinical trial, you acknowledge that you understand and accept all aspects of the research study, including any risks or benefits involved. However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between you and the research staff before, during and even after you decide to become a study volunteer.

To begin, the research staff is obligated to discuss all the pertinent information about the trial with you, its purpose, the procedures involved, the potential risks and benefits. It is your responsibility to ask questions if there is something you don’t understand. You can ask the researcher to repeat the information or explain it in another way using everyday words.

If English is not your first language, research centers can and should be able to produce documents or explanations for you in your preferred language. If not, you shouldn’t participate in the study.

In some instances, a single visit may not be enough time for you to fully understand the information provided. Therefore, it is essential to take the time you need to make an informed decision.

Informed Consent

The informed consent form (sometimes called ICF) is the general overview of a specific study that provides you with important information such as the purpose, duration, compensation, and possible risks and expectations you should have, if you want to participate in that study. These key details will assist your decision in participating or not. Our clinical staff are available to explain the details and answer any questions you have. However, this is not a contract–you may withdraw from the study at any time. Also, every study will have a different informed consent form.

Placebo-Controlled

The informed consent form (sometimes called ICF) is the general overview of a specific study that provides you with important information such as the purpose, duration, compensation, and possible risks and expectations you should have, if you want to participate in that study. These key details will assist your decision in participating or not. Our clinical staff are available to explain the details and answer any questions you have. However, this is not a contract–you may withdraw from the study at any time. Also, every study will have a different informed consent form.

Why should I join a clinical trial?

You may potentially receive early access to new investigational treatments.

Clinical trials may offer alternatives to the common medicines used to treat medical conditions.

You will help advance research and modern medicine

Clinical trials may offer alternatives to the common medicines used to treat medical conditions.

You may receive compensation.

With eligibility, DM Clinical offers participants reimbursement for time and travel. Compensation varies according to each study.

Who can join a clinical trial?

Almost anyone can participate in a clinical trial. You can participate in clinical trials to advance medical research – regardless of your age, health, ethnicity or background. There is no insurance required, nor any proof of legal status or citizenship.

Many trials are for healthy volunteers. These include most vaccine trials. Others are looking for people with specific illnesses or medical conditions, such a type 2 diabetes. These potentially offer participants the chance at access to new investigational therapies, well before they are approved for the general public.

Clinical research volunteers are paving the way by contributing in trials to help bring novel medicines to the US and the world.

Almost anyone can participate in a clinical trial. You can participate in clinical trials to advance medical research-regardless of your age, health, ethnicity or background. There is no insurance required, nor any proof of legal status or citizenship.

Many trials are for healthy volunteers. These include most vaccine trials. Others are looking for people with specific illnesses or medical conditions, such a type 2 diabetes. These potentially offer participants the chance at access to new investigational therapies, well before they are approved for the general public.

Clinical research volunteers are paving the way by contributing in trials to help bring novel medicines to the US and the world.

Yes. Every study is a little bit different.

Most trials offer compensation for your time and effort, which could be anywhere from a few hundred to a thousand dollars or more.

The compensation you receive is approved by an independent ethics board, and is relative to what is required of you in that trial including the length and number of study visits. The compensation is detailed in the informed consent document you will receive at your first study visit.

When you speak with our Patient Enrollment Specialists, please feel free to discuss the compensation with them. We appreciate the sacrifice of your time and effort entailed in study participation, and want to be upfront with you about compensation.

It varies by study. Studies typically require you to come to the clinic a few times, complete e-diaries, and/or speak with clinicians on the phone. The majority of our trials are conducted in outpatient clinics—that means that no overnight stay is needed for most of the studies. Most visits are similar to what you would experience at your regular care visits to your doctor, such as a physical exam, vitals, medical history, blood/urine sample.

It varies by study. The ethics and laws that govern medical practice also apply to clinical studies, and we adhere to these strict standards. However, studies, by nature, involve investigational products that might be ineffective or cause side effects.

Clinical studies are overseen by the U.S. Food and Drug Administration (FDA). Clinical studies also follow strict protocols that we adhere to, and they are reviewed by Institutional Review Boards (IRBs)—a board of highly qualified individuals who are dedicated to ensuring patients’ rights are protected.

Each participant goes through an informed consent process that explains in detail each step of the trial. Our team will help clarify information regarding the specific medicine that is being studied, the number of required doctor or clinic visits, potential side effects and many other aspects of the study and your participation. You are encouraged to ask any and all questions throughout the process.

Each clinical trial is provided with a protocol – which are the guidelines for a study. There are trials that seek patients with a specific medical condition and others that seek healthy participants. Each study is different. The protocol provides inclusion and exclusion criteria depending on various factors that allow us to determine your eligibility or ineligibility for a specific trial

Pharmaceutical companies, various health organizations, and federal agencies fund clinical trials.

No. Clinical trials are funded by various organizations or federal agencies. These sponsors cover the costs of the trial.

It is important to ask questions. Our team is there to provide the information and care you need, so please do not hesitate to ask any questions regarding the study. A few common questions are:

  • Who is my main point of contact?
  • How long will this study last?
  • What is the purpose of the study?
  • Has this study drug been tested before?
  • Why do we believe this treatment would be effective?
  • What kinds of tests and treatments are involved?
  • Will this trial affect my day-to-day activities?

Yes. A patient has the right to choose to leave a clinical trial at any time and for whatever reason. We ask that you let our clinical staff know that you are withdrawing.

This varies by study. When patients are notified whether they received the placebo, we refer to this as “breaking the blind.” Not all studies break the blind. If the criteria allow, you will be notified once the study has reached completion.

Yes. All medical records and research materials that might identify you are held confidential in accordance with the law, and are never sold or shared with third parties.

Our streamlined and organized processes allow us to perform rapid enrollment and fast startup while maintaining a high level of quality source data.

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7103 South Peek Road Suite 220, Richmond, Texas 77407.

713-282-5500

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