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What are Clinical Trials?

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What are clinical trials?

Clinical Trials involve research using volunteers as participants.  In a clinical trial, participants receive specific interventions according to a research plan.

These interventions may be medical products such as drugs, devices, or procedures. Clinical trials may compare a new medical approach to a standard one that is already available to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.

Why to Participate in clinical research?

  • As the main member of Clinical Trials, volunteers are highly valued.
  • Your participation could help millions of people all around the world.
  • You may benefit from new and possibly better developments in medicine, which are not currently available in the market.
  • Any test, medical exams and/or procedures during the study will usually be totally free for you.
  • You may receive additional attention from our medical staff or healthcare providers involved in the study.
  • You may also receive financial compensation for your participation.

Active Studies

Clinical Research FAQs

What should I think about before joining a clinical trial?

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the healthcare team conducting the trial. Also, discuss the trial with your health care provider to determine whether the trial is a good option based on your current treatment.

Be sure you understand what happens during the trial:

For more information please visit:

SourceFDA.gov

Are Clinical Trials Safe?

The FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding 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 participants, some may be unavoidable since we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial.

Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks.

The informed consent is part of the process that makes sure you understand the known risks associated with the study.

Signing it indicates that you understand that the trial is a research and that you may leave at any time.

SourceFDA.gov

Benefits & Potential Risks of Clinical trials

Benefits of  Clinical Trials

  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You may have the chance to help others get a better treatment for their health problems in the future.
  • You may be able to get information about support groups and resources.

Potential Risks of Clinical Trials

  • The new treatment may cause serious side effects.
  • The new treatment may not work or it may not be better than the standard treatment.
  • You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
  • The clinical trial could inconvenience you. For example, medical appointments could take a lot of time or you might be required to stay overnight or a few days in the hospital.

Source: NIH.gov

What information and medical tests are required?

The information and medical test depend on the Clinical Trial. Each study will have different requirements. Some studies may have many tests while others may have few to none.

During the screening visit (first meeting), participants are given an overview of the study and are asked questions to see if they meet the requirements outlined in the study Protocol (rules). Some of the most common tests performed and information asked are:

  • Blood tests
  • A routine physical examination
  • Details on Medical History

 

Source: Uva Health

How many visits are required?

A typical trial proceeds in several phases:

1. A screening visit: During this visit, The informed consent is reviewed with you, as well your Medical History is reviewed by the Investigator Staff.

2. A baseline visit (may be combined with the screening visit).

3. Routine study visits are periodic visits throughout the study to test blood, administrate the study drug and check your condition.

Source: Uva Health

What lifestyle changes or restrictions are required

The lifestyle changes or restrictions during a clinical study depend on the protocol and the treatment to be studied. In some cases, some treatments tend to have more restrictions than others.

Will, it cost me anything to take part in a research study?

Clinical trials test new drugs, devices, or treatments. In some cases, taking part will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.

Source: Cedars-Sinai.org

Reimbursable & Compensation costs

What is reimbursement in clinical trials?

  • Travel expenses
  • Accommodation
  • Loss of income

What is compensation in clinical trials?

Compensation in clinical trials can mean two distinct things:

  • When participants receive monetary or other benefits for their participation in the clinical
  • If participants receive a payment or other services when they suffer any harm from a clinical trial.

Compensation is more common in Phase I trials with healthy volunteers and is usually paid to participants in recognition of their time sacrifice and as an appreciation of their contribution to science.

Source: EUPATI

What happens when the study is over?

At the end of a study, the researchers analyze the data that was collected from all participants throughout the study. Findings and data collected about the subject will be compared with the other participants in the study. In clinical trials, doctors and specialists in biostatistics conduct the analysis and report the findings to scientific meetings and medical journals. Data will also be shared with experts and various government agencies responsible for the approval of new drugs, biologics, and devices.

Source: Uva Health

The right to access your data

You have the right to request to view your records from the trial investigator or the facility where the study was conducted. However, you may not be able to review or make a copy of your records until after the study has been completed. Clinical trial data is highly confidential. Before the study is completed, only selected research staff, sponsor, review boards and regulatory individuals are allowed to see the trial data. Sharing data with any other person before completion can compromise the validity of the study in its entirety and jeopardize patient confidentiality and privacy. The trial doctor will let you know what information they can and cannot share with you before the trial is officially over.

 

Source: Clinical Trials and Me

Clinical Research Definitions

What is a Protocol?

A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will try to answer the research question. A protocol also states how the research team will protect the health and wellbeing of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.

 

Source: EUPATI

What is informed consent?

Informed consent is the process that gives information to people who are thinking about taking part in research. After learning about the research, you should understand:

  • The purpose of the study.
  • The procedures involved in the study.
  • The possible benefits and risks of taking part in the study.
  • The rights of people who take part in research.
  • That taking part in research is your choice.
  • Alternative treatments available.
  • The right to be informed of any new information that may that might change your mind on continuing to participate.

Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. You should take time to talk over your decision with your doctors, family, and friends. If you agree to take part, you will be asked to sign an “informed consent form.”

 

Source: Cedars-Sinai.org

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