What Are Clinical Trials and Are They Safe?

What Are Clinical Trials?

Clinical trials are research studies performed on humans to help evaluate a new medical treatment, drug or device.

The main purpose of a clinical trial is to discover new and improved methods for treating and preventing different diseases, illnesses, and more.

Clinical trials can show researchers what does and doesn't work in humans that cannot be learned in the laboratory or in animals.

With your help, clinical trials can help future generations!

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Why Would I Participate in Clinical Research?

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Unleash Your Citizen Scientist!

Access to Latest Treatments

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One of the most exciting parts of participating in a clinical trial is that you can get paid!

By participating in a clinical trial, individuals can receive financial compensation for volunteering their time.

Clinical trials compensation is dependent upon the length of the time required as well as the procedures performed. Overnight stays typically pay more money than those involving repeat visits.

Are Clinical Trials Safe?

The FDA works to protect participants in clinical trials by ensuring that volunteers have reliable information before deciding whether or not to join a clinical trial.

The Federal government has regulations and guidelines for the management of clinical research to protect participants from unreasonable risks. They require researchers to give prospective participants complete and accurate information on the precise nature of each step of a trial.

Therefore, before joining a study, participants are given an informed consent document that outlines their rights as a participant.

Frequently Asked Questions

The end of the clinical trial does not mark the end of all communication between you and the research team. Once treatment is completed and the study is closed, participants should feel free to ask the trial staff what treatment they were getting. The study staff shares this information as soon as it is available, and they are allowed to do so. They will also share the clinical trial results when they become available.

Source:  ClinicalTrialsAndMe

The following items can be reimbursed for participants:

  • Travel expenses
  • Accommodations
  • Loss of income
  • Meals

What kind of compensation can participants receive?

Compensation, in regards to clinical trials, can take many forms:

  • Participants may receive monetary or other benefits for their participation in the study
  • If participants may receive a payment or other services if they suffer any harm from a clinical trial.

Compensation is most common in Phase I trials with healthy volunteers. It is given to participants as recognition of their time and as an appreciation for their contribution to science.

SourceEUPATI

Personal lifestyle changes or restrictions during a clinical study depend on the protocol and the treatment in question. In some cases, some treatments may have more restrictions than others.

Benefits of  Clinical Trials

  • You may get a new treatment for a disease before it is available to the public.
  • It enables you to have a more active role in your health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You have the opportunity to help others get better treatment for their health problems in the future.
  • You may be able to get information about support groups and other resources.

Potential Downsides of Clinical Trials

  • The new treatment could have potential side effects.
  • The treatment may not work as intended or may not be as effective as treatments that are currently available.
  • Participating in a clinical trial is a time commitment. You may be expected to stay overnight or for several days over the course of a trial.
An important note: Patients who have signed an informed consent form may leave a trial at any time.

SourceNIH.gov

The length of a clinical trial varies depending on several factors, such as the type of illness and the type of medicine being researched. 

For example, if the study is researching a treatment for a chronic condition, participants’ progress on the trial may be tracked over a relatively long period of time.

Studies of antibiotics on the other-hand conclude quickly as patients are typically treated on study for a few days only.

A standard trial proceeds forward in several phases:

  1. A screening visit: During this visit, an informed consent document is reviewed with you, as well as your Medical History by the Investigational Staff.
  2. A baseline visit: When you attend this visit (the first step in your trial) you’ll receive your study medication, and the dosing will be reviewed with you. (This visit may be combined with the screening visit).
  3. Routine study visits  These are periodic visits done throughout the study to track an individual’s progress during a clinical trial. The study team may:
  • Test bloodwork
  • Administer the study drug
  • Perform a checkup on your condition.

SourceUva Health

Depending on each clinical trial, the information and medical tests that are required will change. Each study has a different set of criteria.  Some studies may have many tests, while others may have almost none.

During the screening visit (the first meeting), participants are given an overview of the study and are asked questions to see if they meet the requirements outlined in the study Protocol (rules). Some of the most common tests performed and information asked for are:

  • Blood tests
  • A routine physical examination
  • Detailed Medical History

SourceUva Health

Before joining a clinical trial, it is recommended that you do as much research on the study as possible. Discuss your questions and concerns with members of the healthcare team conducting the trial. Also, discuss the Clinical trial with your health care provider to determine whether the study is a good/possible option based on your current treatment.

For more information please visit:

Source FDA.gov

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FOMAT Medical Research is currently enrolling for a wide variety of clinical trials in the SoCal region!