December 1, 2016

Clinical Trials

Clinical Trials

The Chronically Awesome Foundation is excited about clinical trials, and we are also proud of our history of education and awareness. Before embarking on your journey into clinical trials, please read the information we have provided, talk to your doctor, make sure that a clinical trial is right for you. Once you have read this page carefully, you can search for clinical trials here.

At Chronically Awesome we are pleased to offer you opportunities to participate in clinical trials. Working in conjunction with CureClick we have a way to give you access to treatments before they become widely available, allowing you to take a more active role in your own care, and to make a difference in the health community.*cc_infographics_why

What is a Clinical Trial?

A clinical trial is a research study in human volunteers to answer specific health questions. The clinical trials we give you access to here are run safely. Research trials are the fastest and safest way to find treatments that work in people and ways to improve health.

Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

scalesDeciding to participate in a clinical trial should not be taken lightly. Weigh them carefully and make sure that all of your questions are answered. This checklist may help: risks-and-benefits (pdf)

What else should I do when considering a trial?

clinical trialsDeciding to participate in a clinical trial is an important decision and may seem daunting. It is important that you make a fully informed decision. We have provided information, PDF’s to download and FAQ’s on this page to help you make the best decision possible.

At each step of the way you are in control of your decision.

 

 

 

● Plan ahead and write down possible questions to ask.

● Ask a friend or relative to come along for support and to hear the responses to the questions.

● Bring a tape recorder to record the discussion to replay later.

Understand your rights: clinical-trial-patient-bill-of-rights (PDF)
Understand Informed Consent: informed-consent-process (PDF)

 

clinical trial decison

 

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

How does a clinical trial work?

phases of a clinical trial

FAQ’s

Do I still work with my own doctor during the trial?

Yes. Most clinical trials provide short­term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

May I leave once the trial has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Are the trials approved by the government?

Yes. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensure that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Read more FAQ’s here: clinical-trials-faq (PDF)

*The Chronically Awesome Foundation does not offer medical advice and always suggests you discussing any new treatments with your doctor.

My Relationship to CureClick: http://curec.lk/1Gb4toG

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Clinical trials educational materials are provided byCureClick, CISCRP and ClinicalTrials.gov.

My Relationship to CureClick: http://curec.lk/1Gb4toG (Jules Shapiro for Chronically Awesome)