What are clinical trials?

Clinical trials involve research using volunteers or research subjects to gain or add to medical knowledge, procedures, or treatments.  In a clinical trial, volunteers are evaluated using medications or devices according to the research outline or protocol created by the clinical trial sponsors (usually the pharmaceutical industry or investigators). 

The medications or devices could be medical products, such as drugs, vaccines, devices, procedures, or changes to behavior, such as diet or sleep schedule. Clinical trials may compare a new treatment approach to one that is already approved or in use. Sometimes a placebo is used as a comparator, which is a fake or phony treatment approach that contains no active ingredients, or to no intervention.

When a new medical product, treatment, or device is being studied, it is not usually known whether it will be helpful, harmful, or just the same as available options (including doing nothing).  The clinical research site or investigators try to measure the safety and efficacy of the clinical trial medication or device by measuring certain outcomes in the volunteers. 

Do research volunteers get paid?

Research volunteers are usually paid for their time and travel while participating in a clinical research trial.  Some clinical trials require volunteers to complete a screening visit to see if they are a good match for the project. Some clinical trials require the volunteer to actually join the program before they begin payments. 

The screening process includes (but is not limited to), health related questions, age, gender, medications, etc., among other qualifiers. Every clinical research trial is looking for a certain group of people that fit the study. The protocol tries to match groups of people that best fit the outline of whichever medication, device, or disease being researched. If the groups of people match the outline, outcomes can best be managed. The specific groups of people will change from clinical trial to clinical trial.

The payment per visit will vary based on the level of commitment required by the volunteer. Most often the amount is based on the length of time the study goes on, the amount of procedures performed, the type of medication, and if there are more intense procedures performed. Each completed visit could be a different amount, for instance. Click to view our list of enrolling clinical research trials.

Are Clinical Research Trials Safe?

Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB).  An IRB is made up of doctors, researchers, and members of the community. 

Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.

In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).

Various Federal agencies, including the Office of Human Subjects Research Protection and the FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.

Clinical studies have standards outlining who can participate. These standards are called eligibility criteria and are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll. Click to view our list of enrolling studies.

Will I still keep my regular doctor?

Participants are encouraged to see their usual doctor as participating in a clinical trial rarely, if ever, replaces regular health care. Most clinical studies provide participants with medical products or potential treatments related to the disease or condition being studies, but they do not provide complete health care.  

With your permission, your primary care physician may be contacted so that you can make sure that your participation will not conflict with other medications or treatments that you receive in your regular healthcare or disease maintenance.

Why do volunteers join a research study? 

First and foremost, participation in a clinical trial helps advance medical knowledge.  Results of clinical trials can make a difference in treating many diseases or improving lives. Improving medications, treatments, devices or diagnostic processes helps everyone.

Clinical trials can sometimes allow volunteers access to direct medical benefits, not yet available. Other clinical trials may not provide benefits, but simply move forward with the goal of learning new information about risks, benefits, or confirmation of existing treatments or devices. 

Trials do involve risks and benefits, although it may not be known if potential benefit would outweigh the risks, or be more effective than a treatment or device already approved and available. All of the trials are approved by IRBs where the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits. 

Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These requirements will be described in the informed consent document. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.

Is my information protected? 

Exalt Clinical Research values your privacy and is held to the highest standards by HIPAA regulations in the state of California.  Your personal information will not be shared and will be used only to determine study eligibility.  You can request to withdrawal your personal information at any time.

Information gleaned from the websites listed.

ClinicalTrials.gov

National Institutes of Health: NIH Clinical Research Trials and You 

Disclaimer: The information provided here is a public service of Exalt Clinical Research and is not intended to constitute medical advice. Please consult your physician for personalized medical, dietary, and/or exercise advice. Any medications or supplements should only be taken under medical supervision.  Exalt Clinical Research does not endorse any medical products or therapies.