Clinical Trials: Fact Sheet

This Fact Sheet accompanies the Clinical Trials class in the classroom.

What are clinical trials?

A clinical trial is a term for a test or study of a drug or medical device in people. These studies are done to make sure that the drug or device is safe and effective for people to use 6.

Who can conduct clinical trials?

Clinical trials can be conducted by the federal government, the FDA, National Institute of Health (NIH), pharmaceutical manufacturers, foundations, universities, or individual investigators. It is common for a pharmaceutical manufacturer to fund the study that a foundation, university or individual investigator conducts 2.

What different types of clinical trials are there?

Why are clinical trials important?

Almost all prescription medications that we use today have gone through clinical trials. From this process we have thousands treatments for medical conditions.

What are the potential benefits of participating in a clinical trial?

What are the potential risks of participating in a clinical trial?

What can be expected if my loved one participates in a clinical trial?

Whether or not your loved one qualifies for the clinical trial will depend on inclusion and exclusion criteria. You will also be expected to read and sign a document called an informed consent that will explain all of the requirements of the clinical trial 2.

How are people selected for clinical trials?

There are many medical and social criteria that determine if a person may or may not be allowed to enter a clinical trial, which are called inclusion and exclusion criteria. The inclusion criteria are the standards that make a person a good candidate for a trial and the exclusion criteria are the standards that keep a person from being able to participate in a trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to remember that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe 2.

What is a double blind controlled placebo trial?

In order to study the safety and effectiveness of a new drug, researchers usually do a blinded randomized control trial. This means that some patients will receive the active drug and others will receive an inactive drug, which is called a placebo. To prevent unfairness, neither the patient nor the researcher knows which patients received the active or inactive drug. Regardless if you receive the investigational drug or placebo, you will be under a doctor's care 6.

Why is the placebo necessary?

A placebo is necessary to ensure that the active drug being tested actually works. Several times in past clinical trials, people have responded to the placebo as well or better than the active drug. This is known as a placebo response and is common in Alzheimer's disease. Since Alzheimer's disease is such as dreadful disease, caregivers and researchers are often looking for any signs of improvement. Additionally, the types of things that they are testing cannot be easily measured. It is hard to determine if someone is happier or less agitated today than yesterday. Also, Alzheimer's disease behavior can change from day to day or even minute to minute. When looking at the percentage of people that responded to a drug, it is important to also look at the placebo to see how many people responded to it because some patients may get better when they receive the placebo 6.

How are clinical trials regulated?

The Office for Human Research Protection (OHRP) prepared a policy called the Federal Policy for the Protection of Human Subjects that sets specific standards that people conducting clinical trials must follow. They require that each place that performs clinical trials have an Institutional Review Board (IRB) that reviews and monitors the clinical trial. An IRB is composed of scientists, doctors, and people from the local community that monitor the clinical trials to help make sure that there is the least possible risk to the volunteers. Make sure that any trial you consider enrolling in has been reviewed by an IRB 5.

To view the Policy for the Protection of Human Subjects please visit: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101

Informed Consent

What is informed consent?

Federal law requires that the volunteers be given complete information about the clinical trial before you agree to take part in it. This is known as informed consent. The FDA requires that all volunteers in a trial be told:

The most important part of the informed consent is making sure that you understand all parts of it. If there is anything you do not understand, ask the study personnel and if they do not give you a clear answer, consult your loved one's primary doctor.

Is the informed consent a binding contract?

No, you must sign the informed consent before beginning the trial, but it is not a contract and you can leave the trial at any time, for any reason 7.

For additional information about informed consent, please refer to the Office for Human Research Protection (OHRP) website at http://www.hhs.gov/ohrp/policy/index.html#informed

What should I know before enrolling my loved one in a clinical trial?

What if my loved one is not able to give informed consent?

Each state has different laws, but under Florida Law Chapter 765.401, several classes of persons can consent for incapacitated/incompetent adults. They are listed below in order of who has the greatest legal authority to consent for an incompetent adult. Consent must be sought first from the person at the top of the list. Only if that option is not reasonably available, does the next option apply, and so on down the list. If the first reasonably available person refuses consent, however, that refusal is final. Indicate in both the Introductory Questionnaire and the ICF whom consent will be sought from, again, starting at the top of the list. If the list is partial, it must still reflect the order required by State law. For example, a health care surrogate and attorney in fact may be listed but a proxy cannot be listed unless all the options before a proxy are also listed.

(a) Health care surrogate: Any competent adult expressly designated to make health care decisions for a particular incapacitated individual. The designation should be in writing.

(b) Attorney in fact ("power of attorney"): A competent adult to whom the subject has delegated authority to make health care decisions by means of a validly executed durable power of attorney.

(c) Judicially appointed guardian: All persons who have been adjudged incompetent should have a judicially appointed guardian.

(d) Proxy: If none of the above are reasonably available, then a competent adult who has not been expressly designated to make health care decisions for a particular incapacitated individual but who is available, willing, and able to act is the next option for consent. The following possible proxies should be sought, again in order of priority, working down the list when an option is not available:

(6) A close friend of the subject 9

From University of Florida Informed Consent Form Instructions. Available at http://irb.ufl.edu/docs/icf-instruct.doc

What is an Advanced Directive for Research?

Just as many people have advanced directives for their end of life care, they can also setup an Advanced Directive for Research. This is a document that states the wishes of the individual about their participation in future research and clinical trials. If you are caring for a loved one that is still able to make decisions, this may be something you need to consider.

An Advanced Directive for Research is especially important if the person wishes to participate in clinical trials that would not have direct therapeutic value for the person. One example of this would be a diagnostic trial that would use experimental radiology imaging studies to help diagnose future people with Alzheimer's disease earlier. The person having the imaging studies done would not directly benefit, but future Alzheimer's patients may 8.

Who decides if my loved one is unable to give informed consent?

This may vary from state to state and trial to trial. However, each trial should have very specific information about this on the informed consent document.

What things should I consider before I try to enroll my loved one in a clinical trial?

Alzheimer's Clinical Trials

Where can I find information about current trials for Alzheimer's Disease?

References:

1. Alzheimer's Disease Clinical Trials Database. Available at http://www.alzheimers.org/trials/index.html Accessed on 7/30/07.

2. Basic Questions and Answers About Clinical Trials. Available at http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html accessed 7/30/07.

3. Estrogen Protocol. Available at http://www.clinicaltrials.gov/ct/show/NCT00000177?order=32 accessed 7/30/07.

4. FACT Sheet: CX 516 (Ampalex). Available at http://www.alz.org/documents/national/FS_CX516.pdf accessed 7/30/07.

5. Federal Policy for the Protection of Human Subjects. Available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101 accessed 7/30/07.

6. An Introduction to Clinical Trials. Available at http://www.clinicaltrials.gov/ct/info/whatis#placebo accessed 7/30/07.

7. ORHP Informed Consent Policy Guidance. Available at http://www.hhs.gov/ohrp/policy/index.html#informed accessed on 7/30/07.

8. University of Florida Informed Consent Form Instructions. Available at http://irb.ufl.edu/docs/icf-instruct.doc accessed 7/30/07

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College of Public Health and Health Professions, University of Florida