Exploring Clinical Trials

Thursday, April 16, 2015
Abstract: Clinical Trials tend to be an affordable opportunity for patients looking to explore alternative treatment options. Here’s all you need to know about the ins and outs of clinical trials.

Article: The purpose of clinical trials is to determine whether they supersede the present standard of care. Researchers are always looking for new effective treatment options.

A Clinical Trial is a study of new drugs, a combination of drugs, and/or treatments to see how well they work against the current standard of treatment. There are strict eligibility requirements for participation in clinical trials. An independent committee of physicians, statisticians and members of the community must oversee the eligibility requirements and overall trial to ensure the risks are minimal and the trial is worth the potential benefits.

When considering participation in a clinical trial, it’s ok to ask questions or request a second medical opinion. Even though it may seem overwhelming at times, the more you know about your diagnosis and available options for care, the more you’ll be able to self-advocate. When diagnosed with a chronic, debilitating, or life-threatening illness, clinical trials are a great, cost-effective option to consider. This option becomes especially appealing when ongoing treatment is considered, so go ahead and ask!

Clinical Trials come in all shapes and sizes and serve many different purposes. Here are some clinical trials you might undergo during your treatment.
  • Treatment Trials- These trials test experimental treatments, new drug combos and new approaches to surgery or radiation therapy.
  • Prevention Trials- These trials look for better disease prevention methods including patients who have never had the disease and patients who have already been healed.
  • Diagnostic Trials- These trials explore better test or diagnosis procedure options for those affected by illness.
  • Screening Trials- These trials test different methods of disease and health detection practices.
  • Quality of Life Trials- Also known as Supportive Care Trials, these trials find new ways to improve comfort and quality of life for individuals with a chronic illness.

Each clinical trial has four different phases designed to thoroughly test the new treatments being proposed.
  1. Phase 1: In this phase, the researchers are studying to determine how the drug or treatment will be administered.
  2. Phase 2: In this phase, the researchers are studying the results to measure effectiveness of the drug or treatment. 
  3. Phase 3: In this phase, the researchers are comparing the new treatment against the current standard of treatment.
  4. Phase 4: In this phase, the researchers are monitoring the long-term safety and effectiveness of this treatment.

Just as it is important to research your diagnosis and available options for care, it is also critical to understand your rights and advocate on behalf of yourself during a clinical trial. You have the right to:
  • Understand your treatment options,
  • Know what is involved in treatment including tests, risks and benefits,
  • The right to discuss the trial with the investigator and research team,
  • Hear and read info in language you can understand and ask additional questions, should they arise.
There a multitude of benefits to participating in a clinical trial including:
  • Having access to the latest and promising treatment options,
  • Possibility the clinical trial approach may be more effective than the current standard care,
  • Receiving regular and careful medical attention from a team of researchers, doctors, and other medical health professionals,
  • Being the first to benefit under the new trial,
  • Results from the study might help future patients diagnosed with the illness.
While clinical trials are a great option for many, there are several risks associated with participating in a clinical trial including:
  • New drugs and standard of care are not always better than what’s currently on the market,
  • New treatments  have unforeseen side effects and risks,
  • Patient care might not be fully covered,
  • More doctor visits might be required.
Please note: Clinical trials can be safe. Most clinical trials are federally regulated to protect the participants.

When considering a clinical trial, be sure to read and understand what may or may not be covered under your plan as it relates to clinical trials.

Some specific areas to keep an eye out for include:
  • Reading your Covered Benefits,
  • Reading your Non-Covered Benefits,
  • And reading your Exclusions of plan language.
After reading your plan language you should be more aware of what is and what is not covered. Many states have passed laws or developed policies requiring health plans to cover the costs of certain clinical trials. If your insurance company denies coverage, file an appeal to your provider and request they reconsider and provide coverage for the requested treatment. Include important details like why the treatment is a medical necessity for you. Additionally, there may be some funds available through the trial sponsor to assist you and fundraising organizations that might be able to offset the costs and provide additional clinical trial information.

There are many great benefits to participating in a clinical trial. Occasionally patients will run into obstacles but many of these can be overcome with education regarding your options and availability of resources.

Things you can do to minimize obstacles include:
  • Maintaining an open line of communication with your doctor. If a doctor thinks you may not be open to clinical trials, he may not tell you about them. If you are interested, be sure to let your doctor know.
  • It is possible that you are eligible for a clinical trial out of your area. If this is the case, know that there are many transportation resources available. Many hospitals and treatment facilities also offer assistance to help offset these costs. Some programs offer assistance to help offset transportation costs. Additionally, some programs offer assistance with lodging and meals free of charge to help with the costs. If you’re staying in a hotel, inquire whether they have a medical rate that is more affordable than the standard care of lodging.
  • You may experience loss of income not only for yourself but also the caregiver. There are programs available to you through your employer, including Short Term Disability, Long Term Disability and Family Medical Leave Act. You can also access your sick pool donations and altered work schedule. If treatment lasts longer than a year, apply for Social Security Disability Income or Social Security Income.
Exploring all of your treatment options relevant to your diagnosis will you keep informed and help you make decisions about your health. Clinical trials can offer life-saving treatment and allow you to experience break-through technology, treatments, and cures for your disease.

Currently there are over 24,000 cancer clinical trials hosted in the United States. For a customized, comprehensive list of all ongoing clinical trials, visit clinicaltrials.gov.  Supported by the U.S. National Institutes of Health, this site allows you to search by illness, location, sponsors and more as it relates to your diagnosis.
External Resources

MJH Associates
American Journal of Managed Care
Cure
MD Magazine
Pharmacy Times
Physicians' Education Resource
Specialty Pharmacy Times
TargetedOnc
OncNurse Resources

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