Showing posts with label experimental medicine. Show all posts
Showing posts with label experimental medicine. Show all posts

Dec 4, 2014

The Right Clinical Trial for YOU—Part 1


More than 14 million Americans have cancer. At any given time, there are literally thousands of cancer clinical trials available. These studies are most often at or near large medical centers or universities. Many ongoing trials are unable to find enough participants. If the studies testing new treatments aren’t completed we all lose--new treatments don’t become available to the people they might help. How can this happen?

The facts
·         The pharmaceutical companies are interested in testing, proving, and marketing new treatments. Their mission and business success depends on successful development of new drugs. They want the medication to work.
·         The hospitals and doctors want the drugs to be effective so they can help patients. They are responsible for conducting trials of new drugs under strict controls to safeguard patients and to determine the effectiveness and safety of the drugs and treatments. They want the medication to work.
·         You are interested in managing or curing your cancer. You want a treatment or drug without nasty side effects that is going to manage your cancer, lengthen your life, improve your quality of life, and allow you to live happily ever after. You want the medication to work.

There are more than 6,500 cancer clinical trials available at any one time. For more common cancers, there may literally be hundreds of studies underway at the same time. This is good news. When there are many studies, that means there are many new ideas on how we might improve treatment and find cures. But for you, it can make navigating this a jungle and getting usable information a formidable challenge. 

 Start close to home
A conversation with your own doctor is always the best place to start. Tell your doctor that you are interested in experimental therapies. Your doctor or hospital may, in fact, be offering some clinical trials or may be aware of nearby programs that offer clinical trials for patients with your needs and interests. Even if you end up doing most of the research on your own, your doctor will be a key source of support and information. At a minimum, your doctor will need to share information about you and your cancer with those conducting the clinical trial. You will certainly want the support of your doctor and medical team.

Know your disease state: stage, prior, and current treatments

Before you begin searching, you need to know several key pieces of information about your cancer and treatments you’ve had so far. The more you know, the more quickly you’ll be able to narrow your search to what you want and not waste valuable time. Ask questions.

Each clinical trial is carefully designed for specific groups of patients. For example, phase I studies of brand new drugs are typically looking for patients with advanced cancer that has spread (metastasized) and is not responsive to standard treatments. Since we don’t know very much about how successful these new drugs might turn out to be, proven standard treatments should be tried first. But if nothing else is available, and you don’t have a proven standard treatment to fall-back on, a phase I trial is a reasonable direction to go.

Many trials focus on treatments for advanced cancers, but there are also trials for patients with earlier stage cancer. For example, trials of adjuvant treatment are testing cancer treatment that is administered shortly after the primary surgery or radiation in the hope of reducing the risk of disease relapse or recurrence. Some patients may be cancer-free after initial treatment but their particular cancer had characteristics that suggest a high risk of relapse. They may be interested in and eligible for such studies. Patients who are candidates for standard therapy (at any point in the course of the disease) may want to try clinical trials that are examining new approaches that hope to improve on the standard treatment outcomes.

Clinical trials are available for patients at all stages of cancer and with a broad range of prior treatments but the studies for one stage or situation will probably not be the same as those for another. Knowing your stage and treatment history is absolutely necessary before you can sift through all the possible trials to identify those of relevance and interest to you.

Next? See Part 2 in a few weeks
 




To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 31, 2014

Americans avoid clinical trials—why?


On this blog site we have written several articles about experimental medicine, new drug approval by the FDA, and the low adult participation rate in cancer clinical trials—in the 3% to 5% range. A recent online survey of more than 1000 adult volunteers produced some interesting answers to questions about clinical trials—attitudes, beliefs, fears, costs, and individual needs. 

The poll was commissioned by Research America, the Association of Clinical Research Organizations, the Clinical Research Forum, the Friends of the National Library of Medicine and the Clinical Trials Transformation Initiative. The results were published by PharmaLive.com.

How the 1006 online volunteers responded:
  • 72% said they would likely participate if their doctor recommended it (26% very likely, 46% somewhat likely)
  • 70% said their physicians had never discussed medical research with them
  • The Internet was the most common source of clinical trial information (53%)
  • 51% cited a lack of trust in the process for not participating
  • 53% said a lack of information kept them from pursuing clinical trials
  • 35% were concerned with compensation for participation
  • 27% cited privacy concerns
  • 69% would consider the reputation of the doctor or medical center conducting the trial
  • 37% admire others who participate
  • 73% want to advance medical research

What does all of this mean? A recurring theme is that people don’t have enough information and particularly don’t get enough information from their doctors. There are probably other factors that lead to final decisions. Remember, whatever the numbers in this survey, still only 3% to 5% of adults with cancer ever participate in a clinical trial.

Want to see the Research America Clinical Research Poll questions and results for yourself? How would you respond?
  
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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 18, 2014

Back to basics



Since starting this Cancer Clinical Trials blog in 2011, we have covered a lot of materials, provided links, and talked about the latest experimental drugs. We believe that every once-in-a-while it is a good idea to go back and review clinical trial basics.

What is a clinical trial?
Clinical trials are highly organized and complex experiments to test and compare new therapies in human volunteers who may or may not have cancer. Promising treatments go through a series of tests to make sure they are safe, effective, and have minimal side effects. Testing in humans is the only way to find this information. All the Standard Cancer Therapies currently in use were developed and proven effective in clinical trials. Then they were approved for general use by the FDA (U.S. Food and Drug Administration).

Why would you want to participate in a clinical trial?
You may consider joining a clinical trial if no appropriate standard therapy is available; the current standard treatment leaves room for improvement; or because you don’t need treatment right away because your cancer is slow-growing and you would like to try something new.

Many new ideas are being evaluated in clinical trials today--for a broad variety of cancers. Cancer treatment has advanced and improved rapidly in recent years.There are more cancer survivors than ever before. But many experimental cancer drugs and treatments have not yet been tested in humans because there are not enough clinical trial volunteers.

We will continue to provide a variety of information to increase your understanding and maybe even help you make personal health decisions. We welcome your questions and comments. 


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker