Frequently Asked Questions
You have questions, find answers here.
There are several key factors to consider when selecting a study:
Your ability to comply with the study requirements. This will involve understanding how long the study lasts, how often you will be expected to go to the clinic, and other issues the study coordinator will review with you before you sign up.
The criteria the study has for participation. You may not be a good fit for all studies for your condition. Review the high-level inclusion and exclusion criteria to see if you match what the study is looking for, like specific symptoms and length of diagnosis.
How the drug is administered. Study information will include how the treatment is administered (e.g., a pill or IV). Keep in mind how well you tolerate that type of treatment when deciding whether to sign up for a study.
The different treatment arms. Treatment arms in a study refer to different treatment groups assigned to different dosages of a medication or, in some cases, a placebo. Placebos are a sugar pill administered just like the real treatment, but without active ingredients.
Whether the trial includes an open-label extension. Some trials include an open-label extension, which gives trial participants access to the treatment after the trial ends at no cost. For participants who respond well to the treatment, this can mean many months of access to an effective solution.
Before meeting the study staff for a screening visit — which is a visit to check your health condition and assess if this clinical trial suits you. It often includes blood work, urinalysis, heart rate monitoring, and more — you will complete a digital questionnaire on our platform as a prescreening activity.
Our digital pre-screener is a digital questionnaire designed to ensure that any study you are matched with is right for you and that you find out as early as possible in the process if a study might not be a good fit. The digital pre-screener will start with general questions (such as when you were diagnosed) and continue to more specific questions (such as what medication you are currently taking for your condition). Each of your answers will be automatically processed by an intelligent decision-tree to review all inclusion/exclusion criteria of the protocol and assess your eligibility. If you are eligible and interested, we will schedule an in-person screening visit with the study staff for you.
It is a visit with the medical team at the hospital to check your eligibility for the study. It can include simple questions or tests as described above or specific exams like an MRI or CT scan. Medical teams generally invite patients to the site twice. The first time to explain more about the study to them and the second time to obtain their consent to participate and begin screening activities.
To save you time and energy, we will schedule an on-site screening visit with the medical team only if you’re likely to be a good fit for this study. We will make every attempt to coordinate and share all other information prior to the visit to ensure that you are informed before going in for screening.
Your participation starts when you are enrolled in the trial.
During the first screening visit, you will sign the Informed Consent Form (ICF) with the study investigator and study coordinator. The ICF is a detailed document that is meant to ensure you understand the benefits, risks, and expectations of study participation.
If you sign the ICF, you are considered enrolled in the study and will begin participating in study activities. A screening visit will typically last a few hours and includes a review of your medical history and performance of assessments, such as lab tests and condition-specific assessments. Please note that some screening visits may involve additional appointments with other specialists, such as if an MRI or cardiologic examination is required.
An informed consent form provides a detailed explanation of the purpose of the study, the potential risks and benefits, and the likelihood of those risks and benefits materializing. The goal is to contextualize the study and make sure all participants understand what to expect when participating. All participants must sign an informed consent prior to participation in any clinical research.
Make sure you understand everything the medical staff explains to you. Don’t feel uncomfortable if you have been given the information orally or on a smaller document, known as an explanation sheet, the important point is to receive the explanation in your mother tongue.
Regulations prohibit payment for participation in a clinical trial. If, on the other hand, you are participating as a healthy volunteer, you may be paid.
That said, participants are reimbursed for all expenses associated with participation, such as travel and meals. Some trials also offer additional compensation. Ask the study team before joining.
Optio’s recommendation will consider your preferences to select the study that best accommodates your needs. We will help you to reduce any burden of trial participation as much as possible.
Each trial is different in terms of length. Trials can last for a few weeks up to several years. The length is also dependent on whether the study has extension periods. That said, participation in any clinical trial is voluntary, and participants can drop out at any point if they want to.
Every clinical trial has unique inclusion and exclusion criteria. If you do not qualify for one trial you are interested in, you may qualify for another one in your area. You can also complete your profile here to sign up for alerts from Optio when new trials match your profile.
A placebo is a medication without any therapeutic effect that is used as a means of comparison with a study drug. Not all trials use placebos – for example, cancer trials rarely use them. Some trials measure a study drug against the standard of care for a specific condition or against another treatment. Depending on the trial, you may be able to stay on your current medication, too.
Yes, depending on the study doctor’s assessment. This assessment will consider whether you benefited from the study drug (Did the disease stop progressing or are you in remission). In this case, the study drug can be provided at no cost for up to 3 years under certain conditions. Ask you study team about this before you join the trial.
Yes, you can. Even after you sign the informed consent form, you may choose to leave a clinical trial at any time, for any reason. You just need to inform your study team. You may be asked to give a reason.