Participation Information

Clinical trials are part of a long, diligent process, which may involve many years of research. At the outset, physicians study new treatment options in a lab. This is often followed by studying the treatment in animals. If a new treatment exhibits promise, physicians then test the treatment in humans. This is typically done in three to four steps – or phases. Your doctor may offer you a clinical trial as a treatment option.

Clinical trials are research studies in which patients volunteer to participate. Lynn Institute uses clinical trials to conduct research that represents the highest scientific standards for the purpose of expanding knowledge to provide new treatments and improve patient quality of life.

Placebos, often referred to as sugar pills, are exact copies of a study medication with the exception that they contain no medication. Placebos assist in determining whether the studied medication is successful by comparing patients that receive medication versus patients receiving the placebo. Not all studies use placebos. The ratio of placebo versus actual medication varies from trial to trial, but generally 70% of study patients receive actual medication and 30% receive a placebo. The consent form identifies the actual chances of receiving a placebo for a particular study.

Participants in clinical trials play a more active role in their own healthcare, gain access to new research treatments before they are widely available to the general public, and help others by contributing to important medical research.

No – in fact, time and travel will be compensated for the trial in which a participant is enrolled.

All clinical trials have guidelines regarding participants. Criteria are based on such factors as age, gender, type and stage of a disease, previous treatment history, and other medical conditions. Prior to joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others require healthy participants. It is important to note that criteria are not used to reject individuals personally. Instead, the criteria are used to identify appropriate participants and maintain their safety. The criteria help ensure that researchers will be able to answer the questions they plan to study.

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

• Play an active role in their health care
• Save medical costs by participating in trials
• Gain access to new research treatments before they are available to the general public
• Obtain expert medical care at leading health care facilities during the trial
• Help others by contributing to medical research

Risks
There are risks in clinical trials, which may include:

• The experimental treatment may not be effective for each participant
• The protocol may require more time and attention than would a non-protocol treatment, including trips to the study site, additional treatments, hospital stays, or complex dosage requirements

As with taking any medication there is a risk of side effects, the patient must decide whether the benefit outweighs any possible risks. In any study, the patient’s primary care physician, if they are consulted, will work in conjunction with the study doctor. Together, they will monitor the patient’s overall health and do their utmost to ensure maximum benefits of any clinical trial.

The ethical and legal codes governing medical practice also apply to clinical trials. In addition, all clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, which is a study plan detailing the research that will be involved. Study physicians monitor patients throughout the trial to ensure that the patients are not being exposed to a medication that is potentially harmful. Participants’ privacy is protected by HIPAA. Participants are fully informed of benefits and risks of participating in a clinical trial before they volunteer.

Yes – a participant may leave a clinical trial at any time. When leaving a trial early, the participant should inform the research team of the decision not to complete the trial, and share the reason(s) for withdrawing from the study prematurely.