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Patient Education

Patient Education

At PM Clinical Network, our patients come first. We thrive to ensure Patient safety is our number one priority: Several safeguards are used to help protect people who take part in clinical trials. There are still risks involved with any study, but these safeguards try to reduce the risk as much as possible.

  • Institutional review boards-to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

  • Data Safety Monitor Review Boards-is an independent group of experts that advises  on the primary responsibilities of the DSMB  periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and termination of the trial. 

  • The Clinical Investigator-The clinical investigator is in charge of all parts of a clinical trial. In some settings this person is called the principal investigator, or PI. The main responsibility for patient safety in a clinical trial belongs to the clinical investigator. This includes letting the study sponsor know right away when severe side effects occur.

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Clinical Trials

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Why Consider Participating in a Clinical Trial?

Clinical trials provide means for evaluating a new or existing treatment in patients to see if the treatment, usually a drug, is safe and effective and at what dose. Clinical trials are necessary before a therapy can be approved and offered on the market. Before enrolling in a clinical trial, always discuss participation with your doctor.

           Getting Involved

Starting a trial

Before participating, you will be provided with a document called an informed consent outlining risks and benefits of the study design (features of the protocol such as length of the study and number of visits). After reviewing that document, you might have questions, all of which should be answered.

1

Participating in a Trial

▪ Help ensure a new treatment is developed to control symptoms or overall outcome of their disease.
▪ Gain access to a promising treatment that may provide unique benefit or meet unmet need.
▪ Get access to care at no cost.
▪ Help other patients.
▪ Participate in helping to advance science/medicine.

2

Am I eligible to participate?

▪ Protocols are uniquely designed to each project.
▪ Protocols define eligibility criteria of participants who can be enrolled. These criteria relate to such factors
as age, gender, duration of illness, prior treatments, and other medications you might be taking, etc.
▪ Eligibility criteria fall into two categories:

▪ Inclusion which define the population of patients to be studied.
▪ Exclusion which disqualify certain volunteers from participating due to age, other medical problems or other factors.

3

Is it safe? 

▪ You have the right to withdraw from a study at any time/reason.
▪ Trials are typically monitored by an independent institutional review board that
approves the study design and sites where the study is conducted.
▪ Most trials of new medications performed at multiple sites across the country are monitored 
by a data safety monitoring board.
▪ The FDA has oversight for the trials process and periodically conducts audits at sites .

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Ready to sign up for a trial or have more questions? Feel free to reach out!

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