A clinical trial is a research study that is done to find out if medical treatments can improve people’s health. A medical treatment can be a drug, medical device, medical procedure, or a change in a person’s behavior such as diet or exercise.

Every clinical trial must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.

IRB’s includedoctors, nurses, statisticians, community advocates, and others who make sure that each clinical trial is ethical and that your rights are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and periodically reviews the research to ensure your safety.

Once the trial is approved by the IRB, the organizers of the study must follow a careful plan, called a protocol, that describes exactly what will happen during the study.  You will know the full details of the protocol prior to joining any clinical trial.

New treatments must pass through different phases before they can be released to the public. If the treatment is successful in one phase, it will move to the next one. Patients typically participate in only one phase of a trial. The phases are Phase 1, 2, 3, and 4.

A placebo is a pill or other substance that has no therapeutic effect. If a placebo is part of the trial you’re considering, you will be fully informed of that fact ahead of time. You would only be considered for such a trial when it’s safe and medically appropriate.

Informed consent is the process of learning about the clinical trial before you decide to take part in it. The research team running the trial will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.

If you want to participate, you will sign a consent form that details all the information that has been discussed with the research team. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form, you still have the right to leave the study at any time and for any reason.

Informed consent continues throughout the trial. This will give the research team an opportunity to update you on the progress of the trial as well as any side effects or other risks that have been identified.

Use these questions as a starting point when talking to your doctor about participating in a clinical trial.

Design of the Clinical Trial

• What is the purpose of this clinical trial?
• What phase is this clinical trial and what does that mean?
• Why do researchers believe this new treatment might be effective?
• Has this treatment been tested before?
• Have there been other trials like this one? If yes, what were the results?
• What kinds of patients will be in the clinical trial?
• How many patients are needed for the clinical trial?
• How long will the trial take?  
• Will I find out about the results of the clinical trial?

Eligibility Requirements

• Why is this clinical trial a good fit for me?
• What are my treatment options if I don’t join this trial?
• Are there other clinical trials that might help me?

Potential Benefits and Risks

• How could this clinical trial help me if I join?
• What are the possible risks?
• How will I know if the treatment is working?

Practical Concerns

• What will I have to do if I join?
• Will I have to change my daily activities or my diet?
• Who will oversee my care?
• What type of long-term follow-up care is part of this study?
• Who will pay for treatment?
• If I have questions about the trial, whom can I contact?

Start your search for aclinical trial in your doctor’s office. Talk to your doctor about any trials that he or she knows about that might be right for you.

You can also search for trials online:

• Find trials at K2 Medical that are actively enrolling participants by clicking here: {link to enrolling trials}
• gov is a searchable database of U.S. trials maintained by the National Institutes of Health.

Participants do not have to pay for the clinical trial costs at K2. The trial sponsor covers the cost of research and data analysis, which makes up most trial costs.Participants are also reimbursed for their time and travel per visit.

• You may gain access to new drugs and other treatments, sometimes years before they are widely available.
• You will be monitored closely for any side effects.
• You will have the chance to take an active role in your own healthcare.
• You will be making a valuable contribution to clinical research.

• A clinical trial can sometimes require more time and medical attention than normal care. This can include doctor visits, phone calls, more treatments, or a more complicated treatment regimen. (Ask your doctor for information about the trial you are considering.)
• The treatment might not work.
• The treatment might cause serious side effects.
• Even if a new approach helps some patients, it might not help you.

All clinical trials have guidelines spelling out who can participate. These are called eligibility criteria. The factors that allow you to participate in a clinical trial can include age, gender, the type and stage of your disease, previous treatment history, and other medical conditions.

Following eligibility criteria helps us keep you safe and ensures that researchers learn the information they need.

Yes. You can leave a clinical trial at any time and for any reason.

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

The definition of a healthy volunteer is straightforward—it’s a volunteer that does not suffer from an ailment or condition. The volunteer literally is healthy. The trial may also require that the participant is not taking any medications. Healthy volunteers are essential to clinical studies, as they help provide comparison data for researchers studying the effects of drugs or other treatments on individuals with specific illness. If you qualify as a candidate for the study in question, they may ask you to be a participant in their clinical trial, depending on how many other individuals have volunteered and qualify.

Because K2 Medical Research delivers a new standard for how clinical trials: one founded in respect, compassion, and warmth.  We aim to give our patients a sense of autonomy, equity, and dignity; to provide tools that will allow them to advocate for their own health using the latest advancements the industry has to offer.   We strive to provide our patients with an experience rivalled by only the best medical facilities in the country. Our team of clinicians are not just board-certified experts in their field, they also operate under a holistic model, treating patients as multi-faceted human beings and not just a set of symptoms.