Clinical trials are research studies performed with the help of volunteer participants. Research focuses on new tests and treatments and how they affect patients. These studies are essential to evaluate the side-effects, viability, and potential dangers of new treatments. Clinical trials are generally used to identify if a new treatment or discovery serves to be more effective than what is presently available to the general population. Some clinical trials are used for detecting disease earlier while other clinical trials can be administered on existing patients to see if a new treatment or drug can improve someone’s quality of life and expectancy. Purposes vary, but clinical trials are crucial in discerning what is safe, effective, and often times a new avenue for patients who may not have a treatment available to them presently.

Participation guidelines and eligibility vary for each clinical trial, but all ages, genders, races, and ethnic groups can participate in clinical trials. To be eligible for a clinical trial, you must meet the criteria for the respective clinical trial and be both an informed and willing participant.

Participation in clinical trials is open for any willing participant who fits the eligibility criteria and can follow the outlined clinical trial standards.

Benefits

• Clinical trials will give you exposure to new treatments.
• Clinical trials will allow you to be an active participant when it comes to your own healthcare.
• Most clinical trials are free.

Risks

• Treatment can have serious side effects.
• Treatment may not work.

Before committing to a clinical trial it is important to understand all its requirements. You’ll need to understand how often the treatment is administered, the complexity of the treatment involved, and any other pertinent information. These treatments and medicines usually are new and have not been administered to many patients. You’ll need to be fully informed before committing to any clinical trial.

All clinical trials are required to have willing participants. No one can force you to be part of a clinical trial. If you feel that the clinical trial offered to you is not in your best interest you have every right to decline.

Yes, you may leave any clinical trial at any time.

Informed consent is when a prospective participant commits to a clinical trial after he or she has been made aware of the details of the respective trial.

There are many factors you should consider before committing to a clinical trial. Listed below are a few questions that may help you decide on whether the clinical trial is for you. It is strongly encouraged to ask questions about all clinical trials at the Lorreto hospital. We believe all are participants should be well informed before committing to any type of procedure.

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
• What kinds of tests and experimental treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the experimental treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow-up care is part of this study?
• How will I know that the experimental treatment is working? Will the results of the trials be provided to me?
• Who will be in charge of my care?

Clinical trials are created by our researchers. Once the new treatment or procedure has successfully been tested in the laboratory they are ready for clinical trials.

Clinical teams usually consist of various members but each trial may have a designated physician, a research coordinator, and various associates.

Clinical trials could be sponsored by various organizations which can include but are not limited to pharmaceutical companies, federal agencies, various foundations, and or medical institutions.

Protocols are detailed plans for the clinical trial. These break down what the study is for, how it will be done, and why it is being done.

Placebos are harmless substances provided to a certain sect of the participants to see whether the actual medicine works better than any ordinary (non) treatment.

A control group in a clinical trial would be defined as the group who would not be receiving any treatment by the researchers and then would be used as a benchmark in comparison to how other subjects performed.

• Treatment Trials: Testing new treatment, therapy, and or medicine

• Prevention Trials: Testing ways to better prevent a certain disease and or minimizing the impact of a disease

• Screen Trials: Testing ways to identify health conditions or diseases

• Diagnostic Trials: Testing ways to diagnose certain diseases or conditions

• Quality of Life Trials: Testing ways to improve the quality of life for patients with chronic illnesses

Clinical trials have various phases and each phase has a different purpose.

Phase I Clinical Trials - Researchers are testing a new drug/treatment on a small sample size of individuals to determine dosage range and side effects

Phase II Clinical Trials - Researchers test the medicine and or treatment on a larger group of individuals to further identify its safe usage

Phase III Clinical Trials - Researchers test the treatment and or new drug to an even larger group of people to confirm the results from the previous trials and gather any new information

Phase IV Clinical Trials - Market studies conducted to list out optimal usage of the medicine/treatment and all risks/benefits

• The Protocol Review Process

• Informed Consent Procedures

• The Patient Representative

• The Patient Bill of Rights