Clinical Trials: What You Need to Know

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How Do I Find a Clinical Trial That’s Right for Me?

There are many ways to find out about clinical trials. Most people who take part in clinical trials do so after hearing about them from their doctors. But you don’t have to wait for your doctor to recommend a clinical trial. Many people with cancer actively look for clinical trials online or in other places, hoping to find more options for treatment.

Where to get information about current clinical trials

At this time there’s no one source to find out about all of the cancer clinical trials enrolling patients. But there are several resources you should know about. There are 2 main types: clinical trials lists and clinical trials matching services.

Clinical trial lists

These sources give you the names and descriptions of clinical trials of new treatments. If there’s a certain study you’re interested in, you’ll probably be able to find it on a list. Lists will often include a description of each study, the criteria for patient eligibility, and a contact person. If you (or your cancer care providers) are willing and able to read through descriptions of all the studies listed for your cancer type, then a list may be all you need. Some organizations provide services that can help you narrow the list a little, according to the kind of treatment you’re looking for (chemotherapy, immunotherapy, radiation therapy, etc.) and the stage of your cancer.

Sources for clinical trials lists

The National Cancer Institute (NCI) sponsors most government-funded cancer clinical trials. The NCI has a list of active studies (those currently enrolling patients), as well as some privately funded studies. You can find the list on their website at www.cancer.gov/clinicaltrials/ or by calling 1-800-4-CANCER (1-800-422-6237). You can search the list by the type and stage of cancer, by the type of study (for example, treatment or prevention), or by zip code.

The National Institutes of Health (NIH) has an even larger database of clinical trials at www.clinicaltrials.gov, but not all of these are cancer studies.

CenterWatchSM (www.centerwatch.com) is a publishing and information services company that keeps a list of both industry-sponsored and government-funded clinical trials for cancer and other diseases. You can search their list by things like location, cancer type, or drug name.

Private companies, such as pharmaceutical or biotechnology firms, may list the studies they’re sponsoring on their websites or offer toll-free numbers so you can call and ask about them. Some of them also offer matching systems for the studies they sponsor. This can be helpful if you’re interested in research on a particular experimental treatment and know which company is developing it.

Clinical trials matching services

Several organizations have developed computer-based systems to match patients with studies they may be eligible for. These services are often offered online.

Each may differ somewhat in how it works. Some of the services let you search for clinical trials without registering at the site. If you have to register, they usually assure you that your information will be kept confidential. Either way, you’ll probably have to enter certain details, such as the type of cancer, the cancer stage, and any previous treatments you’ve had. Using this information, matching services can find clinical trials you might be eligible for, and save you the time and effort of reading descriptions of studies that don’t apply to you. Some services also let you subscribe to mailing lists so that you know when new studies open up.

They’re usually free to users, but most clinical trial matching services get paid for listing studies or get a finder’s fee when someone enrolls. It’s important to know this because it may lead to some differences in the way they rank the studies, or the order in which they present the studies to you.

How to choose a clinical trials matching service?

Because each of these services works a little differently, be sure you understand how the service you’re looking at operates. Here are some questions to ask. Note that the answers don’t necessarily mean that the service isn’t worth using; it’s just information you may want to have before you decide to use them.

  • Is there a fee for using the service?
  • Do I have to register to use the service?
  • Does the service keep my information confidential?
  • Where does the service get its list of clinical trials?
  • Does the service rank the studies in any particular order? Is this based on fees they get?
  • Can I contact the service online or by phone?

Sources for clinical trials matching services

The American Cancer Society Clinical Trials Matching Service helps people find high quality care in clinical trials that best match their medical needs and personal preferences. The Society works with NantHealth to provide a free, confidential, and reliable matching and referral service for patients looking for clinical trials. To our knowledge, this is the most complete matching database of cancer clinical trials available.

The clinical trials information provided by the American Cancer Society is not biased in any way. It’s updated every day, as is the contact information that allows patients to get in touch with the doctors and nurses running each of the studies. You can access the American Cancer Society Clinical Trials Matching Service through our toll-free number, 1-800-303-5691.

EmergingMed provides a free, confidential matching and referral service for cancer patients looking for clinical trials at www.emergingmed.com, or you can call 1-877-601-8601.

What you need to know about the clinical trials you find

The study protocol

The study protocol is the written plan for how a clinical trial is to be conducted. It’s submitted to the Food and Drug Administration (FDA) and to an institutional review board (IRB) to get the approval needed before a new treatment can be studied.

The clinical trial lists available online often include summaries of these protocols, highlighting some key points. Research team members may also have protocol summaries or other information about the study they can share with you.

A protocol contains the following information:

  • Why the study is being done (including the goals of the study)
  • Information about the treatment being tested (such as names and doses of drugs to be used in the study), often including results of studies done before
  • The phase of the study and how many people will be in it
  • Who is eligible for the study
  • How the treatment is to be given
  • What tests will be done during the study and how often they’ll be done
  • Other information that will be collected on participants
  • How long the study will last

Actual study protocols can be very long, 100 pages or more, and they can be very technical. Because they aren’t written with patients in mind, making sense of them isn’t always easy. Often, the most important information for patients looking for studies is the eligibility criteria (see below) and any information available on the new treatment.

Eligibility, or inclusion and exclusion criteria

All clinical trials have guidelines about who can be in them. Anyone who wants to take part must fit the guidelines. For instance, some studies are looking for volunteers with a certain type of cancer, or a certain stage of disease, while others are looking for people who have just been diagnosed and haven’t had any cancer treatment yet. The factors that allow a person to sign up for a study are called inclusion criteria. To take part in the study, a person has to meet these criteria.

There are also factors that can exclude a person from each study. For example, a study may be looking for people of a certain age, so people older and younger would not be able to take part. Having certain medical conditions may mean that you can’t take part in a study, as can taking certain drugs. Factors that disqualify people from taking part are called exclusion criteria. These criteria are often used to be sure that the people in the study can safely take part.

For cancer clinical trials, the inclusion and exclusion criteria usually have to do with:

  • The type of cancer a person has
  • The stage (extent) of the cancer
  • Previous treatments a person had
  • The length of time since a person last had treatment
  • Results of certain lab tests
  • The medicines a person is taking
  • Other medical conditions the person has
  • Any previous history of another cancer
  • A person’s activity level (often called the performance status)

Other factors, such as a person’s age or sex, may also be part of the criteria. There are usually other criteria for each study, as well.

Advertisements and clinical trial lists may not contain all of a study’s eligibility criteria. If you’ve found a study you think you might qualify for, you can usually contact someone involved with the study to get a full list of the criteria.

I think I’m eligible. Now what?

Once you’ve found a study and confirmed you’re eligible for it, deciding if it’s the right one for you can still be hard. There may even be more than one study that looks promising. Again, it’s important to learn as much as you can.

Talk with someone connected to the study. This could be the clinical investigator or principal investigator (PI) – the person in charge of the study – or a research coordinator. Research coordinators are usually nurses. One of their jobs is to make sure that people meet eligibility criteria before they get into a study. They also make sure that the study protocol is followed for each patient. They often serve as a link between study patients and their doctors.

Both PIs and research coordinators should be able to answer your questions about the study. They can give you answers about their particular clinical trial, but they won’t be helpful in discussing other studies you might be thinking about. What’s more, they could be biased (even if they don’t mean to be) toward their own study.

If you haven’t done so already, talk to your doctor about the clinical trials you’re looking at. Bring in whatever information you can, so that your doctor can help you figure out what might be right for you. No doctor knows about every clinical trial being done, but your doctor knows your medical situation best and can probably tell you if the study is worth considering. This discussion can take some time, so you might need to make a special appointment to allow your doctor enough time to look over the information.

You might also want to get a second opinion from a doctor not connected to the studies you’re looking at. Doctors who are well known in their fields usually know about the latest experimental treatments, and they may be able to point to those that look more promising.

If you have access to the Internet, you can find some information on your own. Try to find out if the new treatment has been studied before or if it’s now being studied in other diseases, as well as whether any results are available. If this is hard for you, have someone close to you help or do it for you.

Finally, talk to friends and family members you trust. While the final decision is yours, their opinions may give you insight into things you hadn’t thought about.

What about cost? Will my insurance cover it?

It’s important to get insurance and cost questions answered before deciding to take part in a clinical trial.

In most cases, when a patient enrolls in a clinical trial, the study sponsor provides the new treatment at no cost and pays for any special tests, procedures, or extra doctor visits. Some sponsors may pay for more; for example, some may offer to pay you back for travel time and mileage. It’s important to find out what will be paid for before you enter the study.

The Affordable Care Act requires that newer health insurance plans cover the routine costs of care for people who are in approved clinical trials. Insurers are not allowed to drop or limit coverage because a person chooses to take part in a clinical trial. This applies to all clinical trials that treat cancer or other life-threatening diseases, unless the insurance plan is “grandfathered.” (Grandfathered plans are any plan or coverage that a person was enrolled in on or before March 23, 2010.)

Clinical trial-related “routine patient costs” that health insurers must cover includes “all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.” This includes things like hospital visits, imaging or laboratory tests, and medicines.

The law requires coverage for phase I, II, III, or IV clinical trials related to prevention, detection, or treatment of cancer or other life-threatening disease if the study meets one of these requirements:

  • It’s federally funded (any US federal agency such as the National Cancer Institute, Centers for Disease Control, Department of Defense, etc.)
  • It’s covered under an investigational new drug application (IND) that’s reviewed by the FDA
  • It’s exempt from the IND application

According to the new health care law, insurers do not need to pay for:

  • The treatment, device, or service that’s being studied and is usually covered by the trial’s sponsor
  • Items and services only needed for data collection and analysis and are not used in direct patient care
  • Any service that’s clearly not in line with widely accepted and established standards of care for a certain diagnosis

States may require more of their health insurers than this, but these requirements are becoming the minimum. To find out whether your state has special laws about insurance coverage of clinical trials, you can contact your state Health Insurance Commission office, or visit the American Society for Clinical Oncology (ASCO) website at www.asco.org/research-progress/clinical-trials/insurance-coverage-clinical-trials.

Medicare

If you have Medicare, it pays for many of the routine medical costs for people with cancer who are in approved clinical trials. This is true no matter where in the United States you live. Medicare normally covers any cancer care when it’s part of either:

  • A clinical trial for the diagnosis and treatment of cancer; or
  • A clinical trial funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups, or another federal agency that funds cancer research

Cancer prevention trials currently are not covered by Medicare. If you’re not sure whether your trial meets all of the requirements, discuss these concerns with your doctor or call Medicare (1-800-633-4227).

What you can do to

Find out what your insurer will cover before you enroll in a clinical trial. Other trials may be covered, so be sure to ask about other clinical trials before you start one that may not be covered.

Gather as much information as you can about the study and contact your insurance provider to find out about coverage. Many insurers may not be able to give you a simple yes or no answer, because they may review claims on a case-by-case basis. They’ll also want to be sure that the doctors supplying the main part of your cancer care are “in network.”

Study sponsors are often eager to recruit eligible patients for their clinical trials, and they may be willing to cover some costs your insurance does not. If needed, ask your doctor or the research coordinator to contact the study sponsor on your behalf.

References

American Society of Clinical Oncology. Summary the Affordable Care Act Statute Regarding Insurance Coverage for Individuals Participating in Approved Clinical Trials. Accessed at www.asco.org/sites/default/files/aca_summary_clinical_trials.pdf on May 5, 2016.

Bennett C, Adams J, Knox K, et al. Clinical trials: Are they a good buy? J Clin Oncol. 2001;19:4330-4339.

Centers for Medicare & Medicaid Services. Clinical research studies. Accessed at www.medicare.gov/coverage/clinical-research-studies.html on May 5, 2016.

Emergency Care Research Institute. Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness. February 2002. Accessed at www.ecri.org/Documents/Information_for_Patients/Clinical_Trials_Patient_Guide_Summary.pdf on May 5, 2016.

Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials, 4th ed. 2010. New York, NY: Springer Science + Business Media, LLC.

Office of the Legislative Counsel for the use of the US House of Representatives. Compilation of Patient Protection and Affordable Care Act. May 2010. Accessed at http://housedocs.house.gov/energycommerce/ppacacon.pdf on May 5, 2016.


Last Medical Review: 05/03/2016
Last Revised: 05/03/2016