How to become a clinical trial volunteer

Because of what it implies, few people are willing to become a clinical trial volunteer. It is known that, by joining a clinical trial, you expose yourself to possible risks or side effects. Clinical trials are the last step of drug development (sometimes also health devices), and are required before any new drug can be release onto the market. New drugs can be released only if they are proven to be safe for the population and if they show a good efficacy for the targeted disease. Safety data of a new medication on animals is insufficient for its approval by the FDA or other health authorities. Hence, the only way to demonstrate its efficacy and safety is by testing on humans. Therefore, clinical studies are essential to the development of new drugs and treatments. This is why many clinical trials volunteers get involved in the hope they can help other people. If you wish to become a clinical trial volunteer, here is a 4-steps way to joining a clinical trial.

Clinical trials are necessary to determine approval or not of a new drug onto the market

First step – Are you healthy or do you have a specific disease or illness
First thing you need to know: you can be a healthy volunteer, which mean you do not have to be ill in order to join a clinical trial. There are 4 phases in a clinical trial, called Phase I, Phase II, Phase III, Phase IV. Phase I of clinical trials usually involve testing the new medication on healthy volunteers to study its safety on human use. Phase I typically tests for changes in blood work, changes in vital signs, changes in electrocardiograms, short term side effects and any other reactions that can be linked to the investigational drug. Because of the unknown reactions or side effects of the new drugs, Phase I clinical studies tend to compensate generously people who volunteer. Phase II and Phase III of clinical trials generally involve patients (with the targeted disease or illness). During Phase II and III, more safety data are collected, but other goals, such as studying the efficacy of the new drug, how they work in human, the best dosage and way to administer it, its excretion, etc. Phase IV are “post-approval” studies. After their approval by the FDA, pharmaceutical or biotech companies often do phase IV studies in order to collect more information on a larger cohort.

Second step – Determine the clinical trials that suits you
Unlike many believe, chances are that there will be a clinical trial that will suit you. Clinical trial volunteers are welcomed in many fields : migraines, sinusitis, allergies, leukemia, obesity, etc. There are studies for almost every condition that needs a treatment.

Third step – Finding and joining a clinical trial
Many resources are available for you to find a clinical trial. The best place is to start here, on the internet. Several websites offer good directories of centers that run clinical trials, or the active studies. They also allow you to specifically search for an illness, such as migraines or allergies.

Fourth step : Joining a clinical trial: eligibility
When you find a study of interest, make sure you read the eligibility criteria. Is the clinical trial you are looking at enrolling only healthy clinical trial volunteers, or are they only looking for sick patients. Are they looking for men only, or women only? What is the age group they are targeting. Are there other criteria, such as smoking, history of other diseases. Look for the `Contacts` to find where the studies are being conducted and contact information of the center running the clinical trial, or to ask any other relevant question.
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What else do you need to know?

Will the sponsor pay for your travel if you are coming from far away (another city or state) to volunteer.

Make sure you read the consent form carefully and ask the staff to explain all the procedures that will occur during the trial, to avoid any surprise

Know your rights. As a volunteer, you always have the right to withdraw consent from the trial, this at all time. Although, you do not have to give an explanation when withdrawing consent, is it always better to inform the sponsor of your reasons behind it, so they can document it and readjust their goals and next studies if needed. Also, both sponsors and health authorities need to know if there were any abuse or bad treatment from the center conducting the trial.

Where should you look?

“ Clinical Trials (or Clinical Research Trials) study human response to a new drug or therapy. A Clinical Trial Volunteer is a person who volunteers in testing a new drug or therapy. The information is collected at the Clinical Research Center, and will determine whether the investigational compound or therapy will be approved for release on the market.” So you’ve done your preps. You looked up the definition of clinical trials, gathered information and facts on the different phases  (Phase I-IV), different studies (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use), risks and side effects (in regards to different type of phases or targeted disease) and have decided why, you personally, would like to become a clinical trial volunteer.

The next step is now to look for a clinical research center where you would like to join as clinical trial volunteer. If you have been in clinical research trials in the past, you may want to reconnect with the clinical research center: give them a call, to find out what is available for you. However, if for any reasons, you needed to look for a new center, or if you have never taken part of clinical trial, here are the five top places a clinical trial volunteer might want to browse to find a nearby clinical research center.

1.Hospital
A lot of physicians and specialists affiliated with a hospital are also involved in clinical research trials. Therefore, you may want to give the hospital a call and tell them that you would like to become a clinical trial volunteer to find out about any ongoing studies. You can even decide to be more specific and chose a particular department (respiratory, oncology, arthritis, etc.) and directly call the department or visit their website, as many of them will list the type of clinical trials available in their departments. Finally, at your next appointment at the hospital/clinic, make sure you have a look at the board near the font desk, you may find out that the clinic is also a clinical research center and many of the doctors will post their ongoing trials and needs for clinical trial volunteer there.

2.University
Similarly to hospitals, a lot of physicians and specialists affiliated to a university are also involved in clinical research trials. However, to find out about them, it may be easier to look into the university website than to call the university. Also, because a lot of  college students enroll in clinical trials, you may also be able to find many posters about ongoing clinical research studies on the university campus, such as in the cafeteria boards or in general poster boards on the university campus. So on your next lunch break, have a look on the school posting boards and find out a nearby clinical research center.

3.Local Journal
Next time you go for a walk, pick up the free newspaper. To find enough clinical trial volunteers to enroll in their studies, many clinical research centers advertise in local newspapers. Some newspapers have a dedicated section for clinical trial volunteers in the last few pages (ads section) of the newspaper. However, in some papers, you will find clinical research trials ads throughout the whole journal, so while you are reading the latest news about Hollywood, also carefully browse the surrounding ads.

4.Telephone directories
Although more associated to finding a nearby florist or plumber, the Yellow Pages book also contains a useful directory of independent clinical research centers in your region. Those centers are usually not affiliated with any hospitals or universities. So pick up your dusty and heavy Yellow Pages book (or any other telephone directory) or use their online website and search for the trial centers in your area.

5.Internet
The new way of spreading the news and information is through the use of the internet. Although internet allows a quick search, the information gathered may be less specific. For example, although the number of listing and directories for clinical trial volunteers are numerous, it may be difficult to find a clinical research center in your area. As you become more familiar with the terms and with the right sets of keywords, you may find just what you need. So hop on your computer and start “googling” your way through clinical trials.

Finally, although it may give you a good start, the list suggested above is not exhaustive and you may need to look further to find a clinical research center that carries a study that interests you as a clinical trial volunteer. Keep your ears and your eyes open, you will realize that information is more common than you thought: people you may know, radio ads, your family doctor, community center boards, etc.

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Four factors to consider

Clinical trials (or clinical research trials) are conducted with healthy volunteers or patients to evaluate a new medical treatment, drug, or device. The goal of clinical research trials is to find new and better methods of treating different diseases and disorders. Through clinical research trials, the efficacy of a new drug or treatment on humans is determined.

Another important purpose of clinical trials is to find possible adverse events (also known as side effects). Hence, new treatments or new drugs may cause adverse events that need to be detected before they can be approved by the authorities to be released on the market.

Before they are enrolled in a clinical trial, volunteers and patients are informed of any known or possible potential risks in regards to the new therapy they are considering testing. Ultimately, it is always the patient or the volunteer decision to join a study or not, based on their degree of comfort with any potential side effects and their confidence in the new therapy. Participants need to carefully assess the benefits versus the risks of enrolling in a clinical trial. Each patient or volunteer should think out prudently the possible side effects that may occur when testing a new treatment or drug. To help assess those risks, there are a few elements subjects should consider:

First, it is believe, and often with fair reasons, that the risks or the number of side effects that may occur in new therapies are elevated. However, it is important to remember that many of the drugs or treatment already approved and found on the market can also have some side effects . Hence, although some of the new medications will have worst secondary effects than the medicines already approved, many new therapies may have less effects or similar effects to the existing ones.

Second, different subjects may experience different level of tolerance to a new medication. Hence side effects may be different between the different subjects. Pre-clinical research and data often give scientists and physicians imprecise ideas on how people may react to a new drug or treatment. This imprecision adds to the fact that every subject or volunteer is different. Therefore it can be very challenging for the physicians and scientists to determine what exact side effects someone will be experience. In order to help determine and limit as much as possible the potential side effects of a new drug, subjects have to release their medical history.

Third, the type of risks in clinical research trials may also vary depending on the type of disease or disorder the new therapy targets. In this case, the level or risks is rigorously assessed by qualified physicians and scientists from the sporing pharmaceutical company, by authorities and by ethics committees. Those ethics committee consists of qualified physicians and scientists, volunteer and patient delegates, jurists and lawyers and other non-specialists whose duty is to carry out advisory and enforcement responsibilities in regards to clinical trials in an impartial manner.

Fourth, if, at all time, there is any occurrence of a serious adverse event (a side effect that can put one’s life in danger) related to the new drug or treatment, the company sponsoring the new therapy and the principal investigator on site are required to notify the other participants right away. In some cases, the study can even be put on hold or discontinued until more information is available.

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In summary, participants have the rights to know what type of side effects they may encounter during a specific clinical trial. Companies sponsoring clinical research trials, as well as the investigators and their staff are required to alert other volunteers and patients in case of a finding of a serious adverse event related to the investigational drug in one or many participants. And at any given time , volunteers and patients have the right to withdraw their consent from the study.

For more information, visit http://www.clinical-trials-info.com/.

The story of Samantha

Samantha is the mother of two. As her baby child started showing strong symptoms of asthma, Samantha got involved in an asthma and dust study. “It was a very easy study”, she recalls, “Every week someone would come and collect dust from my apartment”. After completion of the study, the staff informed her about other type of studies conducted at the hospital, and that is how Samantha got introduced to the world of clinical trials. Because of her own experience with her child, Samantha decided to join more clinical research studies, with the hope that her involvement will benefit other people with asthma, especially the children. Although she does earn a well-rounded income to support her family, Samantha admits that the other benefit of participating in clinical trials is the supplement income that allows her to indulge herself at times. For example, Samantha uses the extra income to treat herself to trips every year and discover new cultures and old civilizations, without the worries and the guilt of digging in the family savings. Samantha has now been involved in clinical research  studies for over 12 years and has even developed very good relationships with lots of the senior staff at the clinical trial center.

The story of Davis

Davis was a 21 years old student when he started participating in clinical trials. With his busy schedule at school and high tuition costs, he had a difficult time managing his tight budget. As he was reading the newspaper in the bus, an ad regarding a clinical trial at the local university caught his attention. He called the number and after getting all the information and a lot of thinking, Davis decided to join the study. He was a little bit concerned with the possible side effects were a bit of a concern, but for Davis, the payout outweighed the worries. Two year later, even though he finished school, Davis still participate in clinical trials on a regular basis.

The story of Anna

Anna is a young professional who, when she was a little girl, found herself spending a lot of the hospital because of severe asthma attacks. With time, her asthma has improved and she barely uses any medication anymore. Anna is very grateful that, when she was a child, medication was available to help her improve her breathing and allowed her to live a normal life. Today, Anna feels that her participation in clinical trials, especially in asthma clinical trials, will help other people live a better life without having to go through the same childhood experience.

The story of Jake

Jake is a single dad. As a single parent, Jake often found it difficult to pay off the bills and to cover for the needs of his teenage girl in the same time. Although his daughter was very understanding of his situation, Jake sometimes wished he could offer her more. Through a friend of his, Jake learned about clinical trials. He contacted the clinical trial center. Several tests and blood draws later, Jake used his first paycheck to send his daughter on a trip to Europe. Up to this day, Jake still volunteers in clinical trials on an occasional basis, giving him the luxury to treat his daughter every once in a while.

The story of Ricky

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Ricky is a retired teacher. He has always been passionate with helping and teaching other people. Ricky heard about clinical research studies through a television ad. After retirement, as he had more time in hand, he decided to volunteer. Ricky feels that his participation in clinical trials is his way to contribute to new knowledge that may help the sick people. And he adds, “someone has to do it”.