Introduction

NCCS recognizes the need to support clinical trials so that we find answers to scientific questions more quickly, which will translate into better, less toxic treatments and therapies for patients. NCCS also recognizes the Internet’s role in informing patients about these cutting-edge treatments.

Here you will find a kind of primer on cancer clinical trials. Read on to find out more about the phases and types of clinical trials being offered, important patient protections you should consider before participating in a clinical trial and resources to help you locate specific clinical trials.

Note: The National Cancer Institute (NCI) offers a Clinical Trials Education Series on their website.

Types of Trials

There are different types of clinical trials such as treatment, prevention, quality of life and early detection trials. It is important to understand the difference among these trials, particularly the difference between prevention trials and treatment trials.

Patients participating in a cancer prevention trial, for example, may receive some type of placebo, which would allow researchers to compare the effects of a new therapy or treatment as compared to no therapy. However, most of the trials conducted are treatment trials. In cancer treatment clinical trials, patients always receive either the standard therapy or the new therapy or treatment being studied. Patients participating in cancer treatment trials NEVER receive a placebo.

The clinical trial protocol outlines the various components of a given trial such as the amount of a drug to be administered to a patient, the types of tests to give a patient, etc. Strict eligibility criteria are set as well. That means that doctors and researchers may admit only patients who meet all of the criteria into the trial.

Phases of Trials

All clinical trials go through three mandatory phases. After treatments are identified in the lab and/or prove promising in animal testing, a treatment or drug is tested through a clinical trial.

Phase I trials represent the first time a new treatment or therapy is tested on a small number of patients (sometimes only a dozen). Phase I trials evaluate the method of administration (intravenous or oral), frequency and dosage.

Phase II trials focus on the effect of the treatment as an anti-cancer agent. Phase II trials require a slightly larger number of patients than Phase I trials.

Phase III trials are the trials most commonly referred to as cancer treatment trials. Here a large group of patients allow doctors and scientists to compare the results of the new treatment versus what is currently standard treatment. If the new treatment proves effective, it may become the new standard of care. Again, it is important to note that patients participating in Phase III cancer treatment trials do NOT receive a placebo — patients are either given the new treatment or the standard treatment.

10 Things to Know about Treatment Clinical Trials

The following ten points provides a basic introduction to cancer clinical treatment trials and is copied, with permission from the National Cancer Institute (NCI). For more information, please visit NCI online.

1. Clinical trials are research studies that involve people. Each study tries to answer scientific questions and to find better ways to prevent, diagnose or treat cancer.
   
   
2. In cancer research a clinical trial is designed to show how a particular anticancer strategy — for instance, a promising drug, a gene therapy treatment, a new diagnostic test or a possible way to prevent cancer — affects the people who receive it.
   
   
3. A clinical trial is one of the stages of a long and careful cancer research process. Getting promising results from testing a new drug on mice, for example, is a preliminary step to human research studies. Treatments that work well in mice do not always work well in people.
   
   
4. People can benefit from clinical trials. In treatment trials, for example, participants receive high-quality cancer care — and will be among the first to benefit if a new approach is proven to work.
   
   
5. Are there drawbacks? New treatments under study are not always better than, or even as good as, standard care. And they may have unexpected side effects. Through a process called informed consent you will learn about a study's treatments and tests, and their possible benefits and risks, before deciding whether or not to participate.
   
   
6. Who's eligible to participate in a clinical trial? Each study has its own guidelines for who can participate. Generally, participants are alike in key ways — such as the type and stage of cancer, age, gender, and other factors.
   
   
7. Do some people receive a placebo in clinical trials? In treatment trials, involving people who have cancer, placebos are very rarely used.
   
   
8. Many treatment trials are designed to compare a new treatment with a standard treatment, which is the best treatment currently known for a cancer, based on results of past research. In these studies patients are randomly assigned to one group or another.
   
   
9. Where do clinical trials take place? They are underway all over the country — in cancer centers, other major medical centers, community hospitals and clinics, physicians' offices and veterans' and military hospitals in numerous cities and towns around the United States.
   
   
10. Who pays for the patient care costs on clinical trials? Health plans and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. Ask a doctor, nurse or social worker from the study to help you determine in advance what costs are covered. The research costs, such as data management, are covered by the study sponsor.

Patient Protections

While cancer treatment trials may offer patients their best medical option, NCCS also recognizes the importance of maintaining patient protections. The high-quality cancer clinical trials described here require that at least two review panels approve each study’s protocol. The review panels include an objective scientific review panel and an Institutional Review Board (IRB), which oversees clinical research at a local institution. The scientific panel is assembled by the sponsor (i.e., the sponsor could be NCI or a pharmaceutical company developing a new drug). This panel is made up of outside experts (those not involved in conducting the clinical trial) and provides advice as to the scientific merit of the trial. An IRB, which is regulated by federal statute, must approve the protocol before the trial can begin. IRBs also monitor activities throughout the course of the trial. Often IRBs are convened at the trial site and work to ensure that the trial meets the highest ethical, legal and scientific standards.

Informed consent
Patients should learn as much as possible about a particular clinical trial before agreeing to participate. Informed consent is a key part of that learning process. Patients should discuss the risks and benefits of enrolling in a clinical trial with their doctor. If a patient decides to join a clinical trial, he or she will be asked to sign an "informed consent form."

The Informed Consent Form may be intimidating because it lists all of the known risks more so than it outlines the proposed benefits of participating in a clinical trial. Patients should review and fully understand everything on this form before signing it. Even after signing an informed consent form, patients should remember that they have the option to leave the trial at any point in time.

Medical Records Privacy
Informed consent helps to assure legal and ethical standards for patients participating in a clinical trial. Medical records privacy is another important consideration for patients as well.

Changing technology, especially as it relates to electronic records keeping, is impacting how medical records are stored and processed. Currently, there is much discussion on this subject particularly in the United States where an individual’s right to privacy has played such a pivotal role in political debates. Consequently, federal regulations are pending.

Benefits & Drawbacks

A patient may realize after enrolling in a clinical trial that the risks may not be worth the benefits. Here are some common and potential benefits:

• Receiving at least the best standard treatment available
  
  
  
• If the new treatment if better than the standard treatment, then the patient participating in a clinical trial will be among the first to benefit
  
  
  
• The patient is taking an active role in their own treatment

Conversely, here are some potential drawbacks to consider:

• The treatment being studied may not be better than the current standard treatment
  
  

• The treatment being studied may have serious side-effects
  
  

• Patients may have difficulty with insurance coverage* and therefore may be responsible for medical costs beyond what a sponsor covers.
  
  *The financial aspect of cancer care can be daunting. NCCS has worked to change this through legislative action. In June 2000, the Centers for Medicare & Medicaid Services (CMS, formerly the Health Care Financing Administration) enacted a coverage policy for Medicare beneficiaries involved in cancer clinical trials.
  

Finding a Trial

Simply finding what clinical trials are being done is a challenge. No one source lists every trial or even every type of trial. That’s why NCCS recommends that you always discuss participation in a clinical trial with your doctor and that you check a number of resources. Here are some of the best:

• The National Cancer Institute offers a searchable comprehensive listing of clinical trials information for patients, health professionals and the general public. This site includes information about understanding trials, deciding whether to participate in a trial, finding specific trials as well as research news and other resources. It is important to note that NCCS believes NCI to be of the highest quality, but, for example, pharmaceutical industry clinical trials are not listed on this site (e.g., trials evaluating new drugs for FDA approval would not be listed on NCI’s website).
  
  
• OncoLink, which is run by the University of Pennsylvania School of Medicine, provides a comprehensive list of trials. Other medical schools such as Stanford and Harvard also provide an extensive list of trials.
  
  
• CenterWatch offers detailed explanations about clinical trials and how each trial may benefit you.
  
  
• The NCI’s Physician Data Query (PDQ) contains thousands of clinical trials and provides summaries of the trials in both scientific and layperson language. Several dotcom (.com) companies have taken an interest in clinical trials and developed user friendly, technologically advanced websites designed to help match patients to specific clinical trials.
  
  
• TrialCheck® is a Web-based cancer clinical trial search engine available for patients and caregivers.

As more and more patients are using the Internet to inform themselves about these cutting-edge treatments, several patient matching services have gone high-tech. Below is a list of the criteria NCCS is using to evaluated these new sites:

• The site should allow for timely inclusion of new trials and notify users that additional trials have been added to the site.
  
  
  
• The site should provide descriptions of trials and protocols in plain English. By explaining trials and related information in the simplest terms, users will be more likely to understand the process and therefore access this important information.
  
  
  
• The site lists trials defined by NCCS as high-quality cancer clinical trials, which are based on scientific peer review and include those trials sponsored by NIH, NCI, FDA, DoD, VA and other non-governmental agencies adhering to NIH guidelines.
  
  
  
• The site’s privacy policies complement NCCS’ concerns that patient protections and ethical standards be strongly in place.
  
  
  
• The site maintains an open process that allows patients to have knowledge about trial sponsors.
  
  
  
• The site clearly delineates any advertising from its listing of trials so as not to cause the consumer any confusion about where
  
  
  
• The site includes advocates in review of the site and/or the site’s process for presenting credible online information to consumers.

Again, NCCS reminds you to talk with your doctor and check multiple sources in searching for available clinical trials in which you would like to participate.

Resources

Visit the NCCS Resource Guide for a list of organizations, Websites and publications with more information about Clinical Trials.