Joining a clinical trial

Clinical trials (also called clinical research trials or clinical research studies) can be a fast way to earn extra money. However, before enrolling in a clinical research trial, learn about what clinical trials are and carefully weigh the benefits and the risks of enrolling in a clinical trial. Here are the major factors (benefits and risks) you should take in consideration before becoming a clinical trial volunteer.

Potential benefits of clinical research trials

1.Experimental or treatment/drugs difficult to get

Treatments can be expensive and not affordable for many people

Joining a clinical trial can be beneficial to people suffering for an illness, especially serious illnesses. By participating in a clinical research trial, those people have access to medications or treatments that may otherwise not be available to the public. Also, because of their cost, many drugs or treatments may be out of question for several people, so joining a clinical trial may allow these people to have access to appropriate treatments.

2.Outstanding medical care

By participating in a clinical trial, you will have access to a full medical care

Participating in a clinical research trial also imply the access of to one of the best health care, and for free. When participating in a clinical trial, volunteers or patients undergo several health tests and are followed very closely by an experienced medical staff. For example, participants will usually get their blood tested, their urine tested, have their blood pressure checked on a regular basis and may undergo several other tests to determine the degree of illness or how much improvement there is in regards to the studied illness. Participating in a clinical trial may be an option in the U.S. or other countries where medical care is extremely expensive, therefore inaccessible.

3.Helping.
For many people, participating in clinical reearch trials also imply doing something good. It is through clinical trials that is it possible to develop new medications and treatments. Without those clinical trials and volunteers, new life-saving drugs or treatments or new treatments to improve the life of sick people would never find their way to the market. Hence, for many clinical trial volunteers, their participation is a great opportunity to give back and give other people a chance to live a better life.

4.Reimbursement

Paid clinical trials

Clinical resarch trials usually pay, and sometimes quite well. Participating in a clinical trial can therefore be beneficial if you need more money, because they can help you earn extra income.

Potential risks of clinical research trials

1.Side effects (or adverse events)

Side effects

Although the medical staff will inform every participant of all the possible adverse events (commonly called side effects) that you may experience during the trial. However, it is often difficult to predict what possible side effect a participant will experience, as they may experience none or all of the side effects previous participants have experienced. Moreover, because the treatment or medication is still under study, many side effects may not be known, and the participants may experienced other side effects, sometimes extremely unpleasant, even life-threatening. However, the medical staff and the company sponsoring the clinical research trial always closely monitor every subject and are available 24hrs-7days. In the case of a life-threatening side effect, the subject will be taken off the study, and all participants will be informed.

2.Invasive procedures
Some procedures and test may be extremely unpleasant. Before starting a trial, the clinical staff will inform the participant of all the procedure they will undergo. Therefore, before participating in a trial, you should talk to the clinical research staff and let them know if you have any concerns or worries about the procedures involved in the study.
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3.No results
Most clinical research trials have a placebo arm, which mean the participant may not be on the real treatment or medication. Also, in some cases, the new medication or treatment will be ineffective, and simply not work. In the case of a patient suffering from a serious disease however, a second medication, or treatment is added to the main treatment, to prevent the lack of efficacy of the new treatment or placebo.

Hence, before volunteering in a clinical trial, cautiously weigh those factors and determine whether a participating in clinical research trials is for you.

Clinical research studies are classified into four phases (Phase I-IV). Each phase is viewed as a distinct clinical trial. While Phase I, Phase II and Phase III of a clinical trial have to be approved by the regulatory authorities  before they can take place, Phase IV are ‘post-approval’ studies.

Each phases consists of an accumulation of many studies (see Article «Clinical trial design – Studies»).

Phase I
The Phase I of clinical research studies constitute the first set of testing of a new drug into humans. They typically include studies grouped under Human Pharmacology. Phase I  clinical research studies have non-therapeutic objectives and are therefore not usually used for treatment of a disease. They are conducted on a small group of healthy volunteer subjects or on certain types of patients (such as patients with mild hypertension) .  The participants often need to stay overnight at the trial center to be closely monitored and observed. However, drugs that are known to have a high potential of toxicity (such as cytotoxic drugs used in chemotherapy in cancer) are usually studied in patients.

The Phase I of a clinical trial design can be open, meaning that both researcher and subject may know the details of the treatment. Phase I studies can also be baseline controlled: there is an assessment of the volunteer before and after treatment. Randomisation and blinding may also be used. In this case, there is a random allocation of the treatment, without the researcher and/or the subject knowing what treatment is being administered, which lead to more accurate results. The clinical trial design Phase I can involve:

(a)Estimation of Initial Safety and Tolerability is ,used to determine the tolerability of the dose range expected to be needed for later clinical studies and to determine the nature of adverse reactions that can be expected.

(b)Pharmacokinetics information is used to characterize the profile of the new drug about its absorption, distribution, metabolism, and excretion by the human body. Although predominant in Phase I of clinical trials, PK are studied throughout the trial, and other PK studies are carried during Phase II, Phase III and even Phase IV.

(c)Assessment of Pharmacodynamics, to provide an early idea of the activity and the potential efficacy of the new drug. PD can also guide the dosage of the drugs in later studies.

(d) Early Measurement of Drug Activity. Although usually done in later phases, it is possible to carry preliminary studies about drug potential therapeutic benefit in Phase I of a clinical trial, as a secondary objective.

Phase II
Clinical research studies Phase II can be initiated after enough information have been collected from Phase I and safety been confirmed. Their primary objectives are to explore therapeutic efficacy in patients. Phase II studies are used to evaluate how well the drug works, and also to collect additional safety data in a larger group of volunteers and patients. While early studies of Phase II may include be baseline controlled, later studies of Phase II are usually randomized with a placebo control, to evaluate the efficacy of the new drug and its safety under specific conditions or indications.

In Phase II, the therapy or drug is usually administered on a relatively uniform patient population, and groups are larger than those of Phase I. Subjects are closely monitored and information collected is important to determine the doses and treatment indications that will be used during Phase III. More studies under Phase II may be used to assess potential study endpoints, therapeutic restrictions (such as simultaneous or concomitant medications) or target populations (such as mild versus severe disease) for further studies.

Phase III
Phase III studies in clinical trials complete the information needed for the actual drug marketing approval, and give the official product information. For a drug to be approved, it typically has to undergo at least two successful Phase III trials, showing that the drug is safe for human use and its efficacy in the targeted population.

Phase III studies aim to confirm the therapeutic benefits of the new drug on the targeted population, and also to confirm previously collected evidence about drug safety. Additional Phase III studies may be used to research the dose-response relationship or the drug’s use in wider populations, in different stages of disease, or in combination with another drug.

Phase III studies are done on large group patients and are randomized controlled multicenter trials. The size and the relatively lengthy duration of Phase III trials make them notably expensive and time-consuming. Phase III trials can be difficult to design and run, especially in therapies for chronic medical conditions (ICH E1 and ICH E7). Trials involving extended exposure to the drug may be started in Phase II of the clinical trial.

Phase IV
Phase IV studies are post-approval studies and include therapeutic use type of studies. Clinical research studies  Phase IV are not mandatory for drugs and therapies approval, but can be important to optimize their use. Clinical trial Phase IV can be used to refine the dosing recommendation of a drug or to identify rare side effects. Mortality and morbidity or epidemiological studies are other examples of a clinical trial Phase IV studies. Some Phase IV studies have lead to the findings of harmful side effects, and the discontinuation or use restriction of some drugs.
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References:
(1) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Topics 1,5,7
(2) Health Canada
(3) U.S. Food and Drug Administration (FDA)

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”.