Clinical Trials
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Clinical trials are not just for people that have exhausted the“regular” treatment options. Some studies might pair the drugs you were already planning to get with a new one, so you could be getting treatment-plus. If you are newly diagnosed, talk to your doctor now, since some trials are only for first occurrences. Examine all your possibilities.

In assessing what is possible for you, you might need to think about money, time, and travel. Some trials pay for a great deal of treatment. All trials at NIH are free of cost,and NIH will reimburse travel expenses as well. Most other trials pay for the drug and the administration of the trial, but leave the regular treatment costs up to the patient through insurance. Some trials require you to report to the medical center for a week at a time or every three weeks or some other specific schedule — you will need to consider whether you can fulfill the requirements.

Clinical trials also have exclusion and inclusion criteria, listed on the NIH and NCI websites, which will tell you whether you are an eligible candidate. For example, the trial may be age specific or it may require a tumor which the doctor will biopsy. The study might exclude people that have already undergone a certain treatment. Review these requirements carefully and narrow your list.

Clinical trials essentially have four phases:

PHASE I: SAFETY
Often the study will include a dose escalation technique so that the research team can identify the right amount of the drug for future patients. Doctors are looking for information on toxicity and the maximum safe dose, so they will also be monitoring side effects.

PHASE II: THERAPEUTIC EFFECT/SHORT TERM
Often these tests will involve a placebo in a double-blind test. It is important to know if a study you are considering will actually give you the drug you are seeking.

PHASE III: LARGER/LONG TERM
These tests run in multiple locations with lots of patients, often between 1000 and 3000 people to verify that the treatment works over a longer period of time and to monitor the long-term side effects.

PHASE IV: POST MARKET
These studies seek additional information after the Food and Drug Administration has approved the drug — perhaps in a new dosing or with a different type of patient.

When considering a clinical trial, you should get the answers to a lot of questions. Here are a few:

  • Tell me about the investigational drug. What do you hope it will do?
  • Have there been any results with this drug in other studies?
  • Will I be getting the experimental drug or is there a chance that I will begetting a placebo?
  • What is the dose that I will be getting?
  • What are the known side effects?
  • How long does the trial last?
  • How long can I receive the drug?
  • When can I begin?
  • Am I eligible for this study?

At this point it is a good idea to have a full set of your medical records (lots of full sets actually) to show the doctors with whom you might consult. If you have multiple sets handy, it is easy to grab one when anew doctor requests them. And they always do. Some records are easy to keep on a thumb drive (USB drive) as well, and the doctors can download them while you consult.

Once you have identified trials that you might like to participate in, call the facilities and ask to speak to the research nurse for your trial. She will set up a meeting for you to review what the study entails. They will probably give you an examination and maybe a diagnostic test or blood draw. Finally, if you are a good candidate, you will be presented with a consent form whereby you will decide whether to be involved in this clinical trial at all. You do not need to agree immediately. You can take the form home and think about it while you weigh your options.

It is helpful to visit multiple facilities and see a number of doctors if possible as you can to get a feel for the place and the people with whom you will be spending lots of time.

Discussion groups and boards on the internet are a great resource to find advice and to talk to other women in various trials—one you may be considering. These women can relate the process, the successes and/or failures, the side-effects, and to just offer additional support.

Here are a few discussion sites:
Inspire.com
American Cancer Society
WebMD
Association of Online Cancer Resources

Being in a clinical trial is different from getting treated by your regular clinician. There is a higher doctor/staff to patient ratio and you tend to get a lot of attention. The doctors are very interested in everything that happens with you, and there is a lot of communication and face to face contact.

However, there are parameters to being involved in a trial. You cannot change your medications;you must stay within the protocol.The doctors may not like for you to add herbal supplements or other things that could alter the purity of the research results. Essentially, you follow the plan.

It is exciting to test an experimental drug. Perhaps this is the one that will really make a difference for you or even the greater world. And that possibility is downright intoxicating. It also feels wonderful to do something that might help others that follow you down this difficult path. Many women participated in trials to get the drugs and tests that we have now.

Where To Look

You may be considering clinical trials as part of your treatment plan.  Patients join studies at various hospitals to help with the development of new treatments and to access these new treatments themselves. 

Do your research on clinical trials and speak with your doctor to determine if one is right for you. 

Here are a few resources which provide additional information, answer questions, and define important terms:

The National Institute of Health’s (NIH) FAQ
National Cancer Institute (NCI)

More on finding an ovarian cancer clinical trial
TheAmerican Association of Cancer Research
TheCancerGuide
Centerwatch
SearchClinicalTrials.org
Copyright 2012 by CancerDancer