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The Facts

Clinical trials are research studies designed to answer specific questions about new medications that may prevent, treat or cure conditions. These studies are designed to assess both the safety and effectiveness of a product. They are also carefully conducted under strict U.S. Food and Drug Administration (FDA) guidelines.

These are really rhetorical questions (but play along anyway). Have you ever:

been given a prescription medication?
taken over-the-counter (OTC) drugs?
used an inhaler or insulin meter?
had a surgical procedure or
worn a medical device?

Everybody has been touched by advances brought to our society thru clinical research. More valuable than any monetary donation individuals can make, participants are the standout heroes who carry the ball over the goal— who make vaccines, better therapies, even the cure possible. We change each other's lives for the better.

Looking for a guarantee?  They don't exist.
Participants have rights? They trump everything.
Informed consent? Every single time.
Got questions? Ask them all. Whenever you want.
Need time to sleep on it? No rush.
Physicals? Medication? Procedures? Included. For free.
Compensation, too? In many cases.
Need a little handholding?  We got you.
Ready to learn more?  Let's get this party started.

What to Expect

When you participate in a clinical trial, expect to:

Potentially impact the health of many other people, including your own friends and family.
Increase your awareness and improve your knowledge about your personal health.
Gain access to top-notch medical care at no charge to you.
Receive compensation for your time and travel.

When you participate in a clinical trial, expect to be treated like a medical hero, too. You're entitled to feel like the essential research partner that you are. In addition to gaining access to the best medicine has to offer, you'll gain face-time with hot-shot experts, too.

To understand how clinical trials work, review the steps. While studies are all different depending on the disease, what is being tested, and how protocols are designed, all of them have these steps in common to safeguard patient rights, ensure full disclosure and informed consent, and a reliable way to collect the most accurate data for review and approval by the FDA.

What ALL Studies Have in Common

Many participants say that one of the most beneficial aspects of participating in clinical trials is having amazing access to the best medical staff in their chosen fields who are on the cutting edge— who spend considerable time with them and who monitor their health on a regular basis free of charge. Beyond the monetary compensation received as well, participants report looking forward to their visits and learning more each time about the study, their health, and scientific discovery in general. It's often called "fun and exciting" and participating is also a source of pride in what you're contributing to the world and your own family.

KEEP READING FOR MORE...

1. Pre-Screening

This initial conversation takes place by phone or at the clinic with a member of the study team who tells you about the study and asks several questions to establish eligibility. It's really an introduction for best fit.

2. Consent*

Informed consent is both a set of forms AND the process by which patient rights and the study's expectations are explained and you agree to take part.

3. Screening

This involves details about your medical history plus physical examinations and preliminary tests conducted to determine if you meet all study requirements.

4. Randomization

If you're eligible to participate and have consented to enroll, you will be randomly assigned to one of the treatment groups.

5. Study Visits

Your number of visits varies by study. Visits can include examinations, lab tests, dosing, labs, surveys and procedures. Participants can leave the study at any point.

6. Intervention Ends

At this point, your participation will no longer require that you receive the study treatment. Data from all participants are now being collected, analyzed and compared.

7. Follow-up

Your participation doesn't end there. The study team will check in with you by phone or ask you to come in. This follow-up lets them know how you're doing after ending study treatment.

8. Completion

Your participation in the study has officially ended now. The team will keep your contact info for future studies.

A Word About Compensation

Studies compensate participants on a study-by-study basis and it can vary widely.. Just as different studies have completely different areas of interest, exams and procedures they perform. As a reflection of the perceived burden presented to the participant, study researchers/sponsors have pre-set an amount of compensation per participant based on number of visits completed, for example. It really just depends. But it's very easy to find out.

Some studies pay participants each time you show up, while others make you wait until the end of the study or when your participation ends (whichever comes first). All of this is shared with you during the consenting process (informed consent), or even sooner if you ask. We encourage everyone to get clarification on expecatations from the beginning, For some it matters more. Others, not so much. But ultimately, it is your decision alone and you are free to withdraw at any time.

But be aware that getting "paid" to participate is a big "hot-button" topic within industry. Many believe that paying people for their participation— especially if they are "vulnerable"— amounts to coercion. We believe that people should be given all available information in easy-to-digest language and allowed to make up their own minds. But that they should always be compensated for the critical role they play in bringing new therapies to market. Our position at iParticipate is that coercion is improbable in the presence of transparency and informed consent .
What do you think? Feel free to blog here.

Questions?

The FACTS