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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.

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Why Participate in Clinical Research?

  • Volunteering for a clinical trial helps the advancement of medical science
  • 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 to the public.
  • All tests, medical exams and/or procedures performed during a study will likely cost you nothing out of pocket.
  • 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.

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Clinical Research FAQs

What Risks Should I Consider Before Joining a Clinical Trial?

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

 

For more information please visit:

SourceFDA.gov

Are Clinical Trials Safe?

The FDA works to protect participants in clinical trials by ensuring that volunteers have reliable information before deciding whether or not to join a clinical trial.

The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.

The government requires researchers to give prospective participants complete and accurate information on the exact nature of each step of a trial.

Before joining a study, participants are given an informed consent document that outlines their rights as a participant, as well as giving them details on the nature of the study, including any potential risks.

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 the public.
  • It enables you to have a more active role in your health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You have the opportunity to help others get better treatment for their health problems in the future.
  • You may be able to get information about support groups and other resources.

 

Potential Downsides of Clinical Trials

  • The new treatment could have potential side effects.
  • The treatment may not work as intended or may not be as effective as currently available treatments.
  • Participating in a clinical trial is a time commitment. You may be expected to stay overnight or for several days over the course of a trial. Patients who have signed an informed consent form may leave a trial at any time.

Source: NIH.gov

What Information and Medical Tests are Required?

The information and medical tests required will change depending on the Clinical Trial. Each study has different requirements. Some studies may have many tests while others may have almost 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 for are:

 

  • Blood tests
  • A routine physical examination
  • Detailed Medical History

 

Source: Uva Health

How Many Visits are Required?

A standard trial proceeds forward in several phases:

  1. A screening visit: During this visit, an informed consent document is reviewed with you, as well as your Medical History by the Investigational Staff.
  2. A baseline visit: When you attend this visit, the first step in your trial, you’ll receive your study medication and the dosing will be reviewed with you. (may be combined with the screening visit).
  3. A routine study visits Are periodic visits throughout the study that are done to track an individual’s progress during a clinical trial. The study team may:
  • Test bloodwork
  • Administer the study drug
  • Perform a checkup on your condition.

Source: Uva Health

Are any Lifestyle Changes or Restrictions Required?

Personal lifestyle changes or restrictions during a clinical study depend on the protocol and the treatment being studied. In some cases, some treatments may have more restrictions than others.

What are the Costs of Participating in a Clinical Trial?

In some cases, taking part in a trial 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 can ask a member of the research team to explain any costs to you before signing the consent form.

Source: Cedars-Sinai.org

Reimbursable & Compensation costs

The following items can be reimbursed for participants:

  • Travel expenses
  • Accommodation
  • Loss of income

What kind of compensation can participants receive?

Compensation in regards to clinical trials can take many forms:

  • Participants can receive monetary or other benefits for their participation in the study
  • 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. It is usually given to participants in recognition of their time and as an appreciation for their contribution to science.

Source: EUPATI

What Happens at the End of a Study?

Researchers will analyze all collected data from the participants throughout the study. Information collected from each volunteer will be compared with data from other participants in the study. Doctors and specialists in biostatistics will conduct an analysis and report the findings to scientific groups 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

Can I Access my Data?

You have the right to request 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 select research staff, sponsors, review boards, and regulatory individuals are allowed to access trial data. Sharing patient data 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 concluded.

 

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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