Anal Cancer clinical trials are studies conducted on anal cancer thrivers to help determine how effective new treatments are. Taking part in a clinical trial can allow you access to treatment options before they become widely available and allow you to help the cause of advancing research into eradicating anal cancer.

What are Clinical Trials?

Anal cancer clinical trials are research studies that involve people. They look at new ways to prevent, detect, or treat disease. Lee Rosen, MD, FACP discusses anal cancer clinical trials and takes you through myths, facts, and questions to ask when considering trials in this Expert Hour webinar.

Should I participate in a Clinical Trial?

Clinical trials may always be an option for you, at any stage of your cancer. They are not just for people with advanced cancer or cancer that is not responding to treatment. May sure to ask your medical team if trials are an option for you, and bring anything you find to them.

Types of Clinical Trial

There are two main types of clinical studies: clinical trials and observational studies.

Clinical Trials

In clinical trials, the participants receive “interventions” according to the research plan. These interventions drugs or devices; specific procedures; or changes to participants' usual behavior, such as diet. They may compare a new treatment to one that is already in use, or to a placebo, or to no intervention at all. Some trials compare interventions that are already in use, to one another. Investigators attempt to determine the safety and effectiveness of the interventions by measuring the outcomes in participants.

Observational Studies

In an observational study, investigators assess health outcomes in groups of participants receiving certain interventions as part of routine care, but those participants are not assigned to specific interventions as they are in a clinical trial.

Research Plan or Protocol

The person in charge of a trial is called the principal investigator. The person prepares the trial plan, usually called the protocol. This explains what will be done during the trial. Importantly, this protocol contains information that helps the doctor decide if this treatment is right for you. It typically contains information on:

  • The reason for doing the trial
  • Who can join (“eligibility criteria”)
  • How many people they are recruiting
  • What treatments will be given, how they will be administered, dosage, and frequency of dose
  • What medical tests are needed, and their frequency
  • What information will be collected about participants

Safety

There are several laws in place that protect participants, based on many years of learning and experience. Every investigator is required to strictly monitor and safeguard the health of every participant, through rules enforced by the Federal government.

In the US, an Institutional Review Board (IRB) approves every trial. The IRB is made up of a variety of medical experts as well as everyday people. They are dedicated to ensuring that participants aren’t exposed to risks that are not entirely necessary. They regularly review the study throughout to ensure safety.

Many clinical trials are also overseen by a Data and Safety Monitoring Committee. If they find that the experiment is not working or is harmful, they will immediately stop the trial.

Informed Consent

Before joining a clinical trial, you should be told what you might expect as a participant—both the positives and negatives. You will have the opportunity to ask questions and you should feel free to ask as many as you need.

After getting all the information you need, you can still decide not to participate. If you do decide to join the trial, you will be given an informed consent form. By signing this form, you demonstrate that you know all the details and agree to be a part of the trial. This informed consent is absolutely not a contract. You should feel free to leave the trial at any time, without reason, and without feeling judged or restricted from medical care for the decision. All researchers are bound to keep your health and personal information private.

Learn more about benefits, risks, and safety issues with clinical trials.

How to find Clinical Trials for Anal Cancer Treatment

Clinicaltrials.gov is the registry of all clinical trials. The registry is searchable and each listing provides info about the purpose of the trials, who is eligible to take part, the study location, and more. You are able to sort by cancer type, stage, and geography. It's important to remember that listing a study does not mean it has been evaluated by the U.S. Federal Government, so be sure to read the disclaimer on ClinicalTrials.gov for details.

Please discuss all medical decisions with your medical team.

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