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Before you start participating in a clinical trial, you must first provide “consent”, which means you agree to participate . You will receive detailed information about the trial to help you decide. The informed consent process is designed to protect patient safety. It is designed to ensure that all potential trial participants have enough information to make an informed decision about whether or not to take part. During this process, the purpose of the clinical trial should be explained, including what your role might be, how the trial will work, as well as the benefits and risks of participation and any alternatives to the trial. You will also learn about your rights as a participant. This includes the right to decide whether or not to take part in the trial and the right to withdraw at any time, even if the trial is not complete.

At Incyte, we are researching many conditions in our clinical trials. However, the information on this website is not a substitute for a discussion with a healthcare provider. If you decide to participate in a clinical trial, you may learn additional information about your condition, but it is important to remember that a healthcare provider is the single best source of medical advice regarding your health. Please consult a healthcare provider if you have any questions about your condition.

An observational study collects information about you and your medical care. The focus of this type of study is on usual or routine medical care. This is the care or treatment routinely given by a doctor for a certain condition or illness.

A clinical trial is one of two main types of clinical studies. A clinical trial uses people to test out an intervention, which could be a drug, device, activity, or procedure. It is also referred to as an interventional clinical study.

The other main type of clinical study is an observational study. In an observational study, researchers observe participants on their current (or “usual”) treatment plan and track them over time to observe how they respond to a treatment. Observational studies help investigators observe and evaluate a specific question or health outcome in human participants. Participants may receive medical products such as drugs, devices, or procedures as part of their routine medical care. However, unlike in a clinical trial, the participants are not assigned to specific interventions by the investigator.

In order to be prepared for a clinical trial, it’s important to do your own research first. Learn about as a clinical trial volunteer/participant and be sure to talk to your healthcare provider. Plan ahead and write down your questions to ask. Ask a friend or relative to come along for support and to hear responses to the questions. You should ask about the benefits and risks of the study, as well as what will be expected of you. Empowering yourself with knowledge can help you make an informed decision about whether or not a specific study is right for you.

This website provides you with an overview of the clinical trials process and allows you to search for Incyte clinical trials currently in progress.

Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB), which requires protection of patient personal information. Our priority at Incyte is to protect patient privacy and confidentiality. If you participate in a clinical study, your name and personal health information will not appear or be disclosed. All of your personal details will be linked to numbers so that you remain anonymous throughout the study. This continues even after the study is complete, when results are published in scientific journals.

You can enter your condition and search our clinical trials from this website or search all of our trials to find one that may be right for you. All Incyte Clinical Trials are registered on ClinicalTrials.gov, a service of the US National Institutes of Health. You can find other trials by searching clinicaltrials.gov.

When a clinical trial ends, you may or may not be given the results directly. Before any results can be shared, the research team must carefully examine all of the information collected throughout the trial. This must be done before they can make decisions about what those results mean and whether or not they have medical relevance.

Ask your study team and the trial investigators about the results and when to expect them. They maintain access to all of the study records and results. Typically, results cannot be shared until the clinical trial has been completed, and in some cases, certain results might not be shared. But, the main results from clinical trials are often published in peer-reviewed scientific journals and clinicaltrials.gov.

There are situations in which people may seek access to investigational medicines before they are reviewed and approved by a regulatory authority, such as the US Food and Drug Administration (FDA). At Incyte, we sponsor clinical trials and, in some cases, offer expanded access to our investigational medicines.

Medical research done in people must follow strict rules. Every clinical trial has a plan called a “protocol”. The protocol is a set of instructions that everyone in the trial must follow. It is the plan for how the trial will be conducted.

It describes what is being studied, how treatments will be administered and why each part of the trial is necessary.

Before it begins, a trial must be approved by a government department and other organizations including an Institutional Review Board (IRB).

Different countries require different approvals. Approvals ensure that trial participants will be treated well, and risks are managed as carefully as they can be.

Yes. Every clinical trial must be approved and overseen by an “Institutional Review Board”, also called an “IRB”. An IRB is an independent group that makes sure a clinical trial is safe enough to be worth any risk to participants. These group can also be called an “Independent Ethics Committee”, or an “IEC”.

The group can include doctors, statisticians, community advocates, and others. They review and approve the trial plan, called a protocol, and the materials that might be given to the participants. They also make sure that the participants are treated well while they are in the trial.

Yes. Participants should still see their primary care doctor. Most clinical trials only give treatment for one condition over a short time. They do not give other medical care like primary care doctors. Primary care doctors can work with the research team to make sure that a participant’s other medications and treatments will not conflict with the clinical trial protocol.

No. “Standard of care” is a treatment that has already been tested and approved by the government. Standard of Care will be used for comparing the investigational drugs safety and efficacy in many trials, so a patient may receive Standard of Care in a blinded trial.

A placebo looks like a treatment but does not have any real treatment. In clinical trials, investigational treatments are often compared with placebos. Some participants are given a placebo instead of a treatment. This helps make sure that any effects are actually caused by the treatment being studied.

Clinical trials involve a team of people who have different responsibilities. Each person has an important role.

The principal investigator, also called a PI, is responsible for organizing and leading the trial as well as recording and studying the data. The PI provides direction to the team and follows a playbook which is called the trial or study “protocol”. The protocol is a set of instructions on how the study will be conducted.

The research staff members assist the PI in following the protocol. The clinical research coordinator handles the day-to-day activity at the research site. He or she has easy access to the PI and is the main contact for participants. If you have questions about the trial or your health, ask the clinical research coordinator.

Side effects are any undesired or unintended actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Some trials pay for the participants’ travel costs, time and commitment. Not all do. The amount paid varies. You should read the informed consent and ask the study doctor for this information for a specific clinical trial.

The role of personal insurance can vary by region and by trial and will be discussed with each participant before they enroll in a trial.

Yes, all people who participate in clinical trials have specific rights and responsibilities. The doctors and nurses involved in the trial are required to make sure people know these rights and responsibilities before deciding whether or not to participate in a trial.

All clinical trial participants have the right to:

• Clearly understand the risks, possible benefits, tests that will be done, and other information about the trial that is in the consent form

• Receive a signed and dated copy of the informed consent form

• Ask the doctors and nurses any questions about the trial at any time

• Leave the trial at any time and for any reason

• Ask to receive the results of the trial after it is done
  
  

All clinical trial participants have the responsibility to:

• Provide truthful answers to the questions that the study teams ask

• Follow the rules of the clinical trial that are explained in informed consent

Recruiting - The study is currently recruiting participants.

Will be Recruiting - The study has not started recruiting participants.

Recruitment Complete - The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Study Complete - The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Other - All other study statuses such as canceled or terminated

A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions.

Expanded Access - A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use.

Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.

Protocol - The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.

Statistical Analysis Plan - The written description of the statistical considerations and methods for analyzing the data collected in the clinical study.

Results Summary - A brief summary of a clinical study which describes participant flow, demographic and baseline characteristics, primary and secondary outcomes, as well as results of any adverse event information.

Plain Language Summary - A brief summary of the results from a clinical study in which complex technical and scientific terms are explained in plain language for easy understanding by readers who are not scientists or doctors.

Pre-Clinical Development:

• Before clinical trials can be done with human participants, researchers study new investigational treatments in the lab.

• This stage reveals if the drugs should be studied more.

• Once the researchers have enough information, they ask for permission to do clinical trials from the government and independent groups called ethics committees.
  
  

Phase 1 trials:

• Usually the first time a new investigational treatment is studied in humans.

• Learn if a new investigational treatment is safe enough to keep studying in other phases

• Evaluate safety issues, including dose range, side effects, and how the drug works in the body

• Usually take several months to complete

• Usually includes less than 100 participants

Approximately 70% of drugs in a Phase 1 trial will move on to the next phase.

Phase 2 trials:

• Further evaluate safety

• Learn if a New investigational treatment helps people who have a condition

• Usually take several months to several years to complete

• Usually include participants who already have the disease or condition for which the drug is being developed

• Usually includes 100-300 clinical trial participants

About 33% of drugs studied in a Phase 2 trial will move on to the next phase.

Phase 3 trials:

• Help confirm how well the drug works and to monitor side effects

• Provide the majority of a drug’s safety data

• Usually take several years to complete

• Usually includes 300-3,000 clinical trial participants

Between 25% and 30% of drugs in a Phase 3 trial will move on to the next phase.

Phase 4 trials:

• Occur after a medicine is approved by regulatory authorities and is available for patients

• These trials take place over many years.

• They are done to learn how a treatment works when people are taking it as part of their everyday lives.

• Allow researchers to monitor a drug’s risks and benefits, as well as the optimal way to use it