1. What are clinical trials?*
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health. There are different kinds of clinical trials, including those to study:
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.
2. Why are clinical trials done?*
Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the "standard treatments." Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.For most trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration(FDA). FDA sets the rules to make sure that people who agree to be in studies are treated as safely as possible.
3. Who should consider clinical trials and why?*
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials.Some people participate in clinical trials because they have exhausted standard(approved) treatment options - which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.Other people participate in trials because they want to contribute to the advancement of medical knowledge.For each clinical trial, researchers develop eligibility criteria, such as the age, sex, type and stage of disease, previous treatment history, and other medical conditions. These criteria help to reduce the amount of variation in the study, without threatening the scientific integrity of the trial, and by removing medical variations that might complicate analyzing the results.Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.
4. Are clinical trials safe?*
The FDA works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an "informed consent" document before joining the study indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent is part of a process that ensures a prospective participant in a clinical trial understands what known risks might be associated with the study, and whether there are potential, but as yet unknown risks that may be associated with the product being studied. This information permits someone deciding whether or not to enter a clinical trial to make an informed decision about the level of risk they are willing to accept before they enter the trial.
5. What should people think about before joining a clinical trial?*
People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial, the type of health care they will receive, and any costs to them - which may or may not include the cost of the product, costs associated with administering the product, etc.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.
6. What are the potential benefits?*
Participating in well-designed and well-executed clinical trials is one approach for eligible patients/volunteers to:
7. What are the possible risks?*
There are generally known and unknown risks associated with clinical trials, such as:
8. Will I be compensated?*
Subjects are sometimes paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is considered a recruitment incentive. Volunteers may be offered compensation in certain trials for their time, and for discomfort that may be experienced during the trial. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial, and to the level of discomfort that might be associated with medical or surgical procedures related directly to the study. Payment information, including the amount and schedule of payment(s), as well as any possible costs to volunteers who participate in a study, are discussed with potential participants during the informed consent process, and documented in the informed consent form.
9. How do I enroll in a clinical trial at Valley Research?
Valley Research is continually starting new and unique clinical studies. If you are interested in participating in a trial and would like to speak to a study coordinator please call (559)261.0992 between the hours of 6AM and 3PM, Monday through Thursday, or leave a message at any time and a study coordinator will call you back at their earliest convenience.If you would prefer to contact Valley Research over the internet please send an email with your full name, telephone number, medical issues, and a list of all your current medications to email@example.com and a representative will contact you as soon as possible.
10. How do I get to Valley Research?