During a new drug’s early pre-clinical development, the sponsor’s primary goal is to determine if the product is reasonably safe for initial clinical research in humans and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as safe and commercially viable it moves on to the next stage of drug development. The drug is tested in humans by conducting Phase I through Phase III studies. Phase IV trials are conducted after a drug has been shown to work and approved for sale.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to the participants. To help someone decide whether to or not to participate, the doctors a nd nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then, the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Why should I volunteer?
Volunteering in a clinical study is an importand decision to better understand diseases, improved treatment methods and provide alternative therapies for patients.
Who can participate?
Participation in a trial will depend on the trial’s protocol/plan. Each trial is unique and trial participation will depend on a specific trial’s required criteria.
How long do clinical trials last? Each clinical trial has its own time frame and will depend on the treatment being provided to you. Trials can last from a few weeks to months. You will be informed of the specific trial duration requirement before you agree to enter a study.
Each clinical trial has its own time frame and will depend on the treatment being provided to you. Trials can last from a few weeks to months. You will be informed of the specific trial duration requirement before you agree to enter a study.
By enrolling in a clinical trial, you will be an integral part of cutting edge scientific research as well as receive reimbursement for your time and efforts. You can contribute to society by helping to develop new therapies for current and future patients.
Since treatments are new, physicians do not always know what the side effects will be. Some of these treatments may cause problems or side effects that are discomforting and/or serious, while others will produce beneficial outcomes.
Benefits: Eligible participants:
1. Play an active role in their healthcare.
2. Gain access to new research treatments before they are widely available.
3. Obtain expert medical care at leading health care facilities during the trial.
4. Help others by contributing to medical research.
1. There may be unpleasant, serious or even life threatening side effects to treatment.
2. The treatment may not be effective for the participant.
3. The protocol treatment may require more of their time and attention than would non protocol treatment.
What should people consider before participating in a clinical trial?
People should know as much as possible about the clinical trial and feel comfortable in asking members of the healthcare team about the trial as well as the care expected while in a trial. The following questions might be helpful for the participant to discuss with the healthcare team. Some of these questions are found in the informed consent document.
What type of long-term follow up care is part of this study? How will I know that the treatment is working? Will results of the trials be provided to me?
What is the purpose of the trial? What kind of patients will be in the trial? Why do researchers believe the new treatment being tested may be effective? Has it been tested before? What kinds of tests and treatments are involved? How do the possible risks, side effects and benefits in the study compare with my current treatment? How might the trial affect my daily life? Who will be in charge of my care? How long will the trial last? Will I have to give up my current medication? Will hospitalization be required? Who will pay for the 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 treatment is working? Will results of the trials be provided to me?