What is a
Clinical Trial?

What is a Clinical Trial?

Before a medication or new device for treatment of medical issues is available to the public, the United States Food and Drug Administration (FDA) must review and approve the medication or device for public use. The FDA does this to learn more about the product and make sure that it is effective and safe.

To get FDA approval, the company that makes the medication or device is required to conduct clinical research studies.

The companies ask people to volunteer for clinical research studies. In these studies, volunteers are given the investigational medication or device and are evaluated by study doctors and staff members.

After clinical research studies are complete, the pharmaceutical company submits the study information to the FDA. The FDA reviews this information and decides if the investigational medication or device can become available to the public.

How do I qualify?

Every clinical trial has eligibility requirements related to your age, health, and reproductive status. You must meet all of the eligibility requirements to take part in a trial.

If you see a trial that interests you and you meet the stated eligibility requirements, you can apply online to take part. After you’ve applied, a trial staff member will contact you to invite you to a meet with doctors and staff members at our clinic, to discuss the trial and be assessed against the eligibility requirements.

What to expect

If you are eligible and agree to participate in a trial, you’ll be asked to visit our clinic a set number of times (depending on the length and design of the trial).

You may be asked to stay at our clinic overnight. If this is the case, you’ll be provided with a room and meals, and have access to movies, TV (including sports packages), video games, board games, and computers with internet access.

During your trial clinic visits, trial doctors and staff members will evaluate your health and response to any medication you’ve been given and answer any questions you may have. Some of the tests and assessments they use may include:

Reviews of your medical history
Physical exams
Vital signs measurements
Blood and urine sample collections
Questions about how you are feeling
Reviews of any medications you are taking
Reviews of any side effects you may experience

Study doctors and staff members will go over all tests and assessments. You will be encouraged to ask questions about anything you don’t understand.

Refer a Friend

When you select the Share This button, you will be directed to enter your friend or relative’s contact information and the study number. Your friend or relative will receive only one notification about the study.

If your friend or relative participates and is dosed in a clinical trial with us, we may pay you $200-$500, as a way of showing our appreciation for your efforts.

*Compensation only for registered volunteers who have completed a study.

Refer a Friend

FAQs

If I qualify for a study, do I have to participate?

No, you do not have to participate. It is your decision whether or not you want to join a study.

What ID should I bring to my screening appointment?

You are required to bring in a government issue identification, for example a passport, driver’s licence, or State Identification Card.

Can I come and screen for two different studies?

You may only screen for one study at a time.

How long does a screening appointment last?

Typically, screening can take around 2-4hours. Screening consists of a consenting, following consent, screening procedures will commence, the time for these is very dependent on the specific screening procedures for the study.

Can you transfer my screening results from one study to another study, to save me doing two screening visits?

You must attend an individual screening for each study. Each study has varying assessments and blood/urine tests that are performed.

Can I bring my child to my screening visit?

We don’t allow volunteers to bring children to a screening appointment.

Do I get paid for screening and doing the clinical trial?

You will be compensated for your time and inconvenience if you signed the study consent, all payments are outlined in the Informed consent document, the only exception is if you test positive for drugs of abuse (recreational drugs), alcohol, nicotine (if applicable) and/or double enrolled in another study at another site.

If I pass screening and am eligible, will I get dosed on a study?

We are not able to guarantee a place on a study. When permitted we try and fit volunteers onto the next cohort, if they are within the screening window.

What does a backup/alternate volunteer mean?

A ‘backup/alternate’ volunteer is someone who has passed all the screening criteria and is invited for the study admission. The reserve is not dosed unless a confirmed volunteer drops out or is unable to be dosed. The backup subject can usually leave the unit when dosing is complete for those volunteers confirmed. Backup volunteer receives a prorated payment for the study days completed. The payment allowances can be found in the consent form.

Can my family or friends visit me when I’m staying in your clinical unit for overnight stays?

We are unable to accommodate visitors.

If I join a study, do I have to complete the study?

No, you are free to leave a study at any time and for any reason. However, if you do leave a study, the study doctor or study staff may ask you some follow-up questions, and you will not be allowed to re-join the study.

What if I decide I want to stop or withdraw from a clinical trial after I’ve signed an Informed Consent Document?

Volunteers are free to withdraw from a study at any time. This will not affect the standard of care you recieve, or your legal rights.

How many follow-up visits are required?

It depends on the study. Some studies may require more follow-up visits than others. The study doctor or the study staff will go over how many follow-up visits you may need to make.

Will you be paid for participating in a study?

It depends. Each study is different. Contact our clinic to learn more about study participation. Additionally, all study medication, tests, and assessments will be provided to you at no cost.

If I refer a friend for screening, will I get a referral fee?

A referral fee is available for specific populations and study designs. Make sure your referral provides your name when scheduling the appointment.

Can I get study medication outside of clinical research studies?

No, only study volunteers are eligible to receive study medication. Clinical research study medications are not available to the public.

Should I talk with my family, friends, and personal doctor before participating in a clinical research study?

It is always a good idea to discuss study participation with people you trust. Your personal doctor may also be able to discuss other treatment options with you.

Reviews of any medications you are taking.
Reviews of any side effects you may experience.

What type of room will I be staying in?

Rooms are up to 2-4 bed occupancy. These are single hospital type beds with TV remote controls and a call light. There are bathrooms in each room as well as additional restrooms on the unit.

Do I need to provide my own toiletries and towel?

Toiletries and towels are provided at our unit. You may bring toiletries from home, but if they contain alcohol or any prohibited ingredients per the study, they will be confiscated and returned upon discard. Disposable cutlery will be provided. Limit your luggage to two bags and avoid big items. Parexel will not be responsible for loss or theft of personal items.

Is there a washing machine available to use?

A washer and dryer are available at the unit. The laundry schedule can be provided to you at the time of admission. Note the laundry service is not suitable for dry clean only’ items.

What meals are served at the unit?

We do provide Vegetarian options, but this is study dependent. Some studies require you to consume high fat meals. Please note that no outside food is allowed, this includes ordering food while staying on our unit.

Can I bring some snacks and food items with me?

Food and beverages of any kind from outside are not allowed during the in-house period of the study.

Can I have packages and mail items delivered to the unit?

Please arrange alternative address for long in house stays as outside deliveries are prohibited and will need to be checked and may be confiscated until discharge.

Where do I park for Visits?

For screening visits, you can park in the 1560 parking lot. For in-house and follow up visits you may park in west 2 parking structure (not emergency room parking on 1st level). Parking will be validated.

Will I be paid in instalments or all at once?

In instalments, it depends on the length of a study, however, the payment schedule will be available within the Informed Consent Document and information will be provided by the study coordinator.

How will I be paid for the clinical trial and when do I receive my payment?

Compensation will be issued by payment cards. If you withdraw or are removed from the study before study completion for any reason, you will receive a prorated amount of compensation based on the visits you have completed. You must give your Social Security Number or Taxpayer Identification Number to receive payment.

Are there any side effects?

As with any drug, marketed or not, there is always a potential for side effects. Within all our studies and throughout any procedures carried out your safety and welfare are of primary importance. Information regarding any possible side effects of the study drug can be found in the Informed Consent Document.

How long do you keep my data and is it confidential?

We will follow ethical and legal practices and all information about you will be handled in confidence. Data storage timelines vary dependant on the study sponsor, the time data is stored can be up to 25 years.

How long does it take for my blood results to be available?

Most blood results are available within 48hours, some studies have specific tests which can take longer to report. Our staff will update you as soon as results are reported. If requested, we can forward on your blood results in the form of a PDF file via mail or email.

I was a backup/alternate on the last study so does that mean that I won’t be a backup/alternate next time?

There is no guarantee that you will not be a backup/alternate on any admission. Backups/alternates are selected based on results. If all results are within the studies parameters, we then dose in order of which you screened. We will do our best to ensure that backup volunteers can take part in another group of the study if possible.

What are recreational drugs?

“Recreational drugs” is a loose term that refers to legal and illegal drugs that are used without medical supervision. There are four categories of recreational drugs: analgesics, depressants, stimulants, and hallucinogens. We test for all of these at screening and on admission to the unit.

What is WONCBP?

WONCBP means “Women of non-childbearing potential”, this includes women who are post-menopausal, have had their womb removed or are surgically sterile.

How frequently can I take participate in a clinical trial?

The washout period for each study drug is different. The time depends on the next study you wish to participate in and its’ specific exclusion criteria.

What is meant by Wash-out/ Half-life of a study?

Wash out periods are dependent on a study. We require a min of 30 after last dose before you may screen for another study. This is to ensure safety and no interaction between study drugs due to previous participation.

What happens if I’m not able to make an outpatient visit due to a planned holiday/vacation?

Volunteers are required to be available for all study visits. If you cannot attend the outpatient visits for one cohort you will not be able to take part, however, there may be later cohorts with suitable dates.

What is a chronic disease?

A long-term physical health condition (also known as a Chronic condition) is a health problem that requires ongoing management over a period of years or decades. An example is arthritis.

What is a long-term illness?

A long-term physical health condition is one that cannot currently be cured but can be controlled with the use of medication and/or other therapies. Diabetes is a good example.

What do you mean by serious injury or illness?

Serious injury means an injury or illness that: results in permanent impairment of a bodily function or permanent damage to a body structure or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Is there a smoking room within the unit?

Smoking is not permitted within the hospital grounds and is not allowed for most studies.

I gave up smoking a recently, can I take part in your trial asking for non-smokers?

It all depends on the inclusion/exclusion criteria for each study.

I have a family member who works for your company, can they come to visit me?

If you are related to anyone who works for Parexel or the Sponsor this would exclude you from screening/taking part in studies.

Are face masks required?

No. Wearing a face mask is highly encouraged, but not required.

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Do you have more questions?
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Do you have more questions?

Why not give us a call where our team will be happy to answer your questions?