Frequently Asked Questions

A clinical trial is a research program conducted in patients to evaluate a new medical treatment, drug, or device. The purpose of clinical trials is to find new and improved methods of treating different diseases.

There are many reasons people take part in research studies. It gives patients a chance to access medicine not available for prescription to the public. If this is the case, remember the study is being performed to discover if the drug works and to see if it is safe. This means there is information unknown about a drug therefore classifying it as experimental. Often the process of collecting information in the study will allow your doctor to find out more about your disease and the effects it has on you. This may allow you to benefit from better treatment after you have completed a trial. Lastly, a trial may not benefit you directly, but the information gathered may be of help to other patients with the same condition. Many patients derive satisfaction knowing they are part of the effort to potentially reduce the suffering of other people.

Use our Search feature to find trials based on your condition, location, age, and other eligibility criteria. You can filter results to find trials that match your specific needs and schedule.

Clinical trials are conducted in a healthcare setting (a hospital or clinic) and are typically monitored by a trained healthcare professional. An Institutional Review Board or IRB approves all clinical trials. This is a committee made up of doctors, ethicists, members of the general public and administrators. This group is held responsible for agreeing that a trial does not represent an unreasonable risk to patients who are participating. Trials are also reviewed by the FDA. Your doctor is responsible for your well being and is the best person to decide whether or not you are eligible to participate in a trial. Whenever you agree to enter a trial you are given the name and telephone number of a contact in your local physician's office who will answer your questions as well as a member of the IRB whom you can contact if you have any doubts.

Informed consent is the process by which a person learns the key facts about a clinical trial before deciding whether to participate. You will receive a consent form that explains the study in detail, including its purpose, duration, required procedures, and risks and benefits.

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.

There are risks to clinical trials.

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment,including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Most clinical trials are carried out in steps called phases. Each phase is designed to find different information. Patients may be eligible for studies in different phases depending on their general condition, the type and stage of their condition, and what therapy, if any, they have already had. Patients are seen regularly to determine the effect of the treatment, and treatment is always stopped if side effects become too severe. (See the phase descriptions below)

Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing.

Once a drug has been shown to be safe, it must be tested for effectiveness. This second phase of testing may last from several months to two years and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies. Safety continues to be evaluated.

In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's safety, effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Seventy to Ninety percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug.

In late phase III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term safety, effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.

A clinical investigator is a medical researcher responsible for carrying out a clinical trial's protocol. Investigators are either doctors, nurses, pharmacists, or other health care professionals.

Yes. Participation in clinical trials is entirely voluntary. You can leave a trial at any time for any reason without penalty or loss of benefits to which you are otherwise entitled.

Research sites can register by contacting our team or completing the site registration form. Our onboarding team will guide you through the process of getting your site listed and connected with sponsors.

MyClinicalTrial provides comprehensive tools for volunteer recruitment, enrollment tracking, protocol management, communication with sponsors, and regulatory document management.

Our platform automatically matches your trial eligibility criteria with registered volunteers in your area. You can review matched profiles, send invitations, and manage the entire enrollment pipeline from one dashboard.

MyClinicalTrial.com is an informational website, created by CSSi. CSSi is the industry leader in delivering strategic patient recruitment and enrollment solutions to study sponsors, CROs, SMOs and investigative sites with our vast experience.

MyClinicalTrial.com is designed for volunteers, study coordinators, physicians, pharmaceutical companies and clinical research organizations to learn more about the development of medicines and medical devices. Our goal is to educate people about the importance of clinical trials, provide the latest industry information and act as a source for anyone searching online for health and health care information.

MyClinicalTrial.com offers patient recruitment and enrollment exclusive services to Sponsors, CROS, and individual Research Sites that can monitor and track recruitment results, request additional services, and post trials to be featured on MyClinicalTrial.com for patients looking for clinical studies. In addition to MyClinicalTrial.com, CSSi also offers

• Development of recruitment tools and materials
• Effective planning and placement of traditional media (including print, television, radio)
• Online media placement (email, google, Facebook, yahoo, banner ads on websites)
• Out-of-home media (Highway billboards, bus banners, post cards, subway advertising)
• Pre-screening 100% of subject calls for sites - through our 24-hour integrated voice and web system

MyClinicalTrial.com features searchable clinical trial listings on its web portal. Listings are accessible to visitors via keywords, zip code and distance. When a visitor identifies a clinical trial, their contact information is submitted to the study center through our integrated, online referral process.

Patient referrals generated through your study listing can be transferred directly to your call center and/or site for screening and accessible through the MyClinicalTrial portal.

Once you have registered, you will receive an email notification for all Study Participant referrals at any email address that you specify. You will then log in to the portal to access the referral contact information. Please ensure that the email address is one that is monitored only by authorized individuals as the referral information is considered confidential.

MyClinicalTrial.com tracks the referrals from each study posting and/or project. When potential subjects from your study listing are directed to a branded recruitment website developed and hosted by CSSi, a full range of real-time, online performance metrics is available along with customized reports are your convenience.

Our extremely cost-effective recruitment for individual, nationwide, or multi-site pricing is based on which services you are interested in for your studies. Typically, patient recruitment services are charged monthly. If you would like to customize pricing for your site or if you are a CRO/Sponsor you may contact us for more information.