What is Clinical Trials Research?
Clinical trials research involves the testing of new investigational drugs or medical devices. Such research is done in order to evaluate new drugs that have not yet been approved or are pending approval by the US Food and Drug Administration (FDA). It also may be done to test approved medications against a new drug, in new patient populations or in other circumstances.

Clinical trials research often enables us to determine the effectiveness and safety of a new drug. Sometimes effectiveness is measured against a known standard. Sometimes effectiveness is measured against a sham treatment or placebo (sugar pill). Therefore, people who participate in clinical trials research may be in studies in which they receive an investigational drug, an existing (approved) medication, or placebo. Safety often is determined by the occurrence of adverse events (AEs), which are untoward events that occur in association with the use of investigational medication. While many drugs produce AEs, investigators are quite concerned that these do not significantly harm or inconvenience subjects. The health and safety of subjects who participate in clinical trials always is a primary concern.

Who Pays for Clinical Trials?
Support for clinical trials comes from the Federal government (funded by the National Institute of Health or another government agency), private sources (such as not-for-profit foundations), and private industry (pharmaceutical companies). There typically is no cost to participants for their involvement in a clinical trial.

Should I Participate in a Clinical Trial?
People participate in clinical research for many different reasons. Those who participate may receive new investigational drugs long before they are approved for sale to the public. Subjects also are likely to receive high quality healthcare services as part of their involvement in clinical research. Such services typically involve study-related medical workups and laboratory testing, as well as follow-up care, from experienced clinicians during the course of their participation. Finally, many people are motivated by their interest in contributing to the development of new medications that may be used for the treatment of medical conditions. Although subjects often are paid to participate in clinical trials, financial compensation is not intended to be an inducement.

Many people are concerned about the risks associated with participation in a clinical trial. While risks are present, subjects' rights and safety are protected by a system that requires independent review of research, full disclosure of research activities, and preservation of one’s right to decline participation. Independent review is among the most important of these protective mechanisms. Clinicians who conduct clinical trials research must obtain approval to conduct their studies from an Institutional Review Board (IRB). According to the United States Food and Drug Administration (FDA), an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. The IRB review process includes, but is not limited to, the examination of study protocols, study-related advertising, and subject compensation; and plays a critical role in ensuring that the safety, rights, and welfare of human subjects are protected. The IRB has the authority to approve, require modifications to, or disapprove research. Protocols that are determined to be inappropriate are not approved.

People who participate in clinical trials must sign "informed consent" forms. These forms provide information regarding the study that is being conducted, its purpose, and any potential benefits or risks. The informed consent form is a document that is approved by the IRB, and is intended to provide subjects with a detailed description of what will or might happen to a subject in the study. The informed consent process is designed to ensure that subjects are aware of the potential benefits and risks associated with their participation in a trial.

Subjects also are protected by the option to discontinue their involvement in a clinical trial. Investigators have the right to terminate a subject's participation in a study if they believe that continuation poses an inappropriate risk to the subject, and subjects may discontinue their participation in a study at any time for any reason. Discontinuation is never to be associated with any imposed penalty.

Subjects should be aware that the informed consent process offers them an opportunity to ask questions about the study in which they are considering participation. Questions such as: "What are your credentials?" or "What is the purpose of the study?" or "What are the risks of participation?" are appropriate to ask if this information is unclear. Every investigator who conducts clinical trials research is required to provide full informed consent, which includes providing complete and satisfactory answers to any questions that you may have. If you're considering participation in a clinical trial program, you may wish to speak with your primary care doctor.

How do Clinical Trials Differ from Treatment I Receive from My Doctor?
Clinical trials involve many familiar aspects of the doctor-patient relationship. Clinical trial participants are carefully evaluated by a doctor, and if appropriate, they are assigned to receive investigational medication as part of a study protocol. However, clinical trials are not "treatment" in the traditional meaning of the term.

While some people may benefit from participation in our studies, some participants may receive an ineffective drug or placebo.

Traditional treatments often are tailored to the immediate needs of the patient, while clinical trials are conducted according to a protocol that specifies how the investigational medication is to be used, and how assessments are to be performed.

As with all medication, subjects may experience adverse events (AE's), which are untoward events associated with the drugs being tested. However, common AE's associated with an investigational medication may or may not be known at the time of the subject's participation in a clinical trial.

Individuals who participate in clinical trials may receive monetary compensation. Such compensation is given in recognition of the individual's time and effort. It is not intended to be an inducement to participate.

How Do I Participate in Clinical Trials Research?

There are 3 easy steps to completing a clinical trial screening:

Step 1: Questionnaire Assessment If you would like to enroll as a subject in one of Clinilabs' studies in the New York metropolitan area, you may complete one of our questionnaires on-line, or contact us at 212.994.4567 between 9 AM and 5 PM Eastern Time. Click here to see a full list of ongoing clinical trials and questionnaires.

Step 2: Confidential Telephone Interview The second phase of screening is a brief, confidential telephone interview with a study coordinator. The interview will enable us to better judge your medical history and health status. Following the completion of this phase, we will determine if you are eligible for an appointment at our office in Manhattan.

Step 3: Office Visit If you pass the telephone screening, you will be invited to our office for a medical evaluation, which may include a physical examination, blood work, an electrocardiogram (heart monitoring), and other assessments. Once you pass the office-based screening, you will be invited to enroll in one of our clinical trials!

If you would like to consider participation in other studies, not conducted by Clinilabs, you may obtain information by visiting the Web sites listed on our Reference Links page.