The Lewy Body Rollercoaster: Participating in Research: Part 2

Last week's blog was the first how of a summary of a presentation by Dan Kaufer MD, of North Carolina at the 2019 International LBD Conference. It discussed the value of and need for clinical trials and their structure, design and purposes. This week we dig a little deeper and discuss the components of clinical trials and what you should know before you participate.

Clinical Trial Components:

Institutional Review Board (IRB)

Board members: doctors, researchers, members of the community

Tasks:

Review, approve, and monitor all clinical research studies
Ensure that research risks are minimized and are reasonable in relation to any potential benefits
Review the informed consent document to make sure it is understandable and clearly describes the risks and benefits of the study

Informed Consent

Provides potential and enrolled participants information about a clinical study

Intended to help a person make an informed decision about the risks of, potential benefits of, and alternatives to the study

A person must sign an informed consent document before participating in a research study

Signing the document and providing consent is not a contract
Participants may withdraw from a study at any time

Clinical Study Research Plan

A clinical study is conducted according to a research plan (protocol) that is designed to answer specific research questions and safeguard the health of participants and covers the following :

Reason for conducting the study
The number of participants needed
The schedule of tests, procedures, or drugs and their dosages
The length of the study
What information will be gathered about the participants

What Do You Need To Know?

Many studies have strict criteria for the study and the subjects. You need to know the following before you sign up.

Study Basics

What is being studied?
What is the therapeutic rationale for this treatment?
What do we know about possible treatment effects?

Subject Eligibility

What is the target population?
Inclusion criteria: age, diagnosis, severity, etc.
Exclusion criteria: age, severity, prohibited medications, other medical conditions, etc.

Treatment Arms (components)

What are the possible interventions (e.g., treatment vs. placebo) that I might receive during the trial
How will it be determined which intervention I receive (for example, by chance)?
Who will know which intervention I receive during the trial (blinding)?

Other Medications

Can I take my current treatment(s)?
Are there any medications that I am not allowed to take?
Are there other treatment options available?

Study Requirements

What will I have to do to participate?
Do I need to have a study partner?
What tests and procedures are involved?
How often will I have to visit the hospital or clinic?
Will I have to stay overnight?
How long will the study last?

Cost/Payments

Who will pay for my participation?
Will there be an issue with my insurance company due to experimental vs. standard care?
Will I be reimbursed for other expenses such as travel?
Who will oversee my medical care while I am participating in the trial?
What are my options if I am injured during the study?

Follow-Up I Termination

What if I decide to withdraw from the study?
What type of long-term follow-up care is part of this trial?
If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
Will results of the study be provided to me? (e.g., which treatment arm, brain imaging data, genetic testing, etc.)?

Now, go find a clinical trial and join up! Just be aware that if getting a new experimental treatment is your ONLY reason for signing up, you are likely to feel cheated if you end up in the placebo group. If you look at the whole process as a way of helping the researches find out more about LBD, then getting to be in the non-placebo group can be a wonderful, but unexpected bonus to an already good adventure.