Are Cancer Clinical Trials becoming more successful?

First you’ll need to define ‘SUCCESS.’
 

According to numerous studies and reports, Cancer Clinical Trials have a very low success rate—somewhere in the 5% to 7% range of all trials that are proposed. This is from Phase 1 (or pre-phase 1) to eventual FDA approval. This is not so good except that without even that modest success rate many of us Cancer Survivors would not be surviving.

Success is often defined in terms of producing an actual positive impact in treating and managing cancer and increasing cancer survival. Check out the National Cancer Institute site for more details. 

So are Cancer Clinical Trials Getting More SUCCESSFUL? YES or NO? 

If SUCCESS means more experimental results leading to new and effective drugs—Then NO. (Success rates have not improved in recent years­­­­­­—they have actually decreased)

If SUCCESS means more people are volunteering to participate in trials—Also NO. (Some potentially successful trials never even get started due to lack of participants)

If SUCCESS means the trial stages and FDA approval procedures are progressing more quickly—Definitely NO. (Final FDA approval can take many years)

If SUCCESS means ‘affordable’ prescriptions for cancer patients—Still NO, you’ve got to be kidding (Some well-insured patients are not even able to afford the co-pays)

If SUCCESS means weeding out the least promising drugs in the early stages—Mostly YES. (Ineffective or dangerous drugs can be replaced with new, more promising experimental drugs)

If SUCCESS means there will be some effective new drugs approved for patients—YES, but at a rather slow pace.

Over the years we have encouraged our readers to volunteer for clinical trials when given the opportunity. Your participation could help you, others, and add to the cancer information base. Many different types of information can prove to be useful in the study of cancer.

For example, this author, now with Metastatic-late stage prostate cancer and in a Chemotherapy regimen, is still participating in several clinical trials including a study of  the effect of pain in cancer patients, how cancer affects quality of life, relationships, etc.

Cancer Clinical Trials information and data can be useful even when a particular trial is not successful in curing, treating, or managing cancer. For example, side-effects you experience may provide information to help others avoid or manage the same side-effects, allowing a promising trial to continue. 

Progress in the whole Cancer Clinical Trials world depends on multiple factors. You have the chance to influence some of these factors by participating in trials and surveys, sharing medical records, sharing your cancer experiences, and encouraging and supporting others. Keep on keeping on and never lose your sense of humor.

Post Text Here
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

A Blog is a Blog is a Blog…

Or is it??? 

This blog was started in 2012 just after our book, Cancer Clinical Trials, was published. Our goal was to provide information about clinical trials, new meds, FDA approvals, how to participate in clinical trials, and other information related to cancer clinical trials. We have tried to be positive, encouraging, and occasionally make you smile. This reflects our outlook on life. Our blog entries are primarily aimed at those with cancer, those thinking about participating in a clinical trial, and the family and friends of those with cancer.

Some have questioned our inclusion of humor. Is there a place for humor in this serious subject? Cancer is not funny, of course, but a positive attitude, sense of humor, and ability to laugh may make life a little easier. This author, Larry, has been living with prostate cancer for 12 years. Being able to laugh at myself, the idiosyncrasies of the medical world, high drug prices, endless forms to fill out, strange side effects, etc. has made my quality of life a little better. We have been pleased to receive positive feedback from many blog followers.

There are literally millions and millions of blogs out there somewhere. There is something for everybody. They run the range of the very scientific, factual and useful information of all sorts, entertainment, political (not necessarily factual), personal diaries, pictures of cute kittens, and probably more than a few X-rated and nefarious ones. The odds are good that you or someone you know has a blog.

Cancer is the topic of a lot of these blogs. Many are dedicated to specific cancers (breast, lung, prostate, skin, and on and on). Then there are the personal information and experience blogs which are not always factual (we hope ours is), and all are infinitely varied. We hope you will follow our blog, but you may find others you prefer. The advantage of having so many choices is that you’ll surely find just what you’re looking for. 

We will continue to provide cutting edge cancer and clinical trial information, a few personal anecdotes, and a bit of humor‑‑often in the form of G-rated cartoons.

 Post Text Here
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

Larry and Tom interviewed: prostate cancer, clinical trials, and our book

We were interviewed by the blog JoinClinicalTrials.com a while back.  Here we share the interview with you:

1. How did the two of you become colleagues/friends and what was the inspiration behind your blog? 

We met in the prostate cancer clinic as patient and physician and forged a friendship over the years.  The blog, along with the book was inspired by a strong desire to share knowledge about clinical trials with people who are living with cancer and who are called upon to make decisions about their cancer care. 

 2.  You are co-authors of the book Cancer Clinical Trials. Please tell us about it and what prompted you to write a book about clinical trials?

For 15 years now I have been deeply involved in clinical trials.  I have talked to thousands of cancer patients about hundreds of clinical trials.  Despite the fact that we spend a lot of time with each potential participant, I frequently had the nagging feeling that in the course of a clinic visit, or even several, we could never quite do a good enough job sharing all the knowledge I wanted to share with my patients.  The book was the only way to get this done.

 3. Dr. Beer, could you please address some of the common misconceptions and fears that people have in regards to clinical trials?

Well, there are many, and we cite examples throughout the book of misconceptions we have run across.  I think the first thing people worry about is that they will get a placebo and not a real drug.  We talk a lot about the way placebos are used in research in the book.  I think that is the area where there are the most misconceptions. 

There are many other areas.  For example, many people think that clinical trials are only appropriate when all other options have been exhausted.  That is not true at all.  Clinical trials are seeking to improve care across the entire spectrum of the disease and may be worthy of consideration at various points in the battle with cancer.

 4.  (Dr. Beer) Many people think that clinical trials are an option only after they have tried every other treatment for their cancer; however, is that really the case? Is it possible for patients to participate in trials in different stages of their disease?

No question about it.  Clinical trials seek to improve care in all situations including front line care.  The trials may be different in patients that have good standard treatment options.  For example, the standard treatment may be included for all patients and the new drug is added to it. 

But without clinical trials that test even the most fundamental cancer treatments, we would not have made the advances we have.  For example, breast cancer is often treated with surgery that removes only the cancerous lump and spares the breast.  Clinical trials that proved this was a sound approach are responsible for women being able to keep their bodies intact through cancer treatment.

More of our interview in the next post.

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) 2013 Tom Beer and Larry Axmaker

How to keep track of the latest clinical trials that one may be eligible for

The single most complete resource for clinical trials in cancer is offered through the NCI at www.cancer.gov.  Clinical Trials are listed under the Clinical Trials and the Find a Clinical Trial tab on the www.cancer.gov website.  Detailed instructions on how to use this search tool are available on the website.  We also provide a discussion of that in our book, Cancer Clinical Trials.  Once you set up a search that fits your specific situation, there is an easy way to track the latest trials.  The trial status component of the search form allows you to check the new trials box. This will show you only trials added in the last 30 days. This feature is very helpful if you want to track any new trials that are activated without going through the entire list every time.  A useful strategy is to do a thorough search for clinical trials once and then repeat the same search with the new trials box checked every 30 days.  This way, one can be sure not to miss anything new. 

For more questions and answers about clinical trials, visit the Talk about Health website.
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

US health care costs: where are we getting our money's worth

A recent article on the PBS website by Jason Kane provides a thorough and thoughtful discussion on US health care costs and how they compare to other countries.  

We spend considerably more on healthcare than everyone else, including other rich countries, and in most areas we do not seem to get our money's worth.  Our health and our longevity are no better than others who spend much less.  In many areas of medicine, we do more procedures and more tests than the rest of the world, but don't seem to get better results.

So are there any areas where we do get some bang for our buck?

Yes there are.  The author points out that cancer outcomes are better in the US than anywhere else and these are important outcomes, like survival!  The other area where we lead the world in is medical research.  There are currently 119,469 clinical trials underway in the United States, far more than any other country.  In addition to that, new drugs and devices get approved faster in the US than most other places.  Yes, you heard that right. 

We need to get better value for the health care dollars that we spend, but it's great to know that there is one area where we appear to get our money's worth and that is cancer care.  

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

Explaining Risk: Know Your Aristotle

To make informed decisions about your healthcare, we absolutely need to understand risk.  Whether you are facing cancer or deciding whether it's worth treating your blood pressure, understanding risk is central to understanding what your choices really mean.  Aristotle can help.  This is a great article everyone should read.  Click here to read it.

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

What are cancer clinical trials about: a webinar for you

Today, Larry and I were joined by Evan Denhart in presenting a webinar about clinical trials.  In the two part discussion we talked about clinical trials, what they are, how they work, and what it is like to participate.  Then we discussed the AFFINITY study, a newly launched phase III clinical trial for advanced prostate cancer.  We took questions and had a great time.  See and hear it all here.  This presentation takes a while, so you can preview it quickly, but you will need to set aside a bit of time to get the most out of it.  Hope you enjoy it.

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

An invitation to a reading at Powell's

If you are in Oregon, you surely know Powell's, our signature book store.  The largest independent bookstore in the country, I heard.



Larry and I will be visiting Powell's on Wednesday, September 12 at 7 P.M. for a reading and conversation about clinical trials

This is at the Cedar Hills Crossing Powell's store at 3415 SW Cedar Hills Blvd (not at the downtown store).

Details here

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

Cancer Clinical Trials: what does “significant” mean?

When we hear the words there was a significant treatment effect, you would naturally assume that significant means large, important, or noteworthy. This may be true—but not necessarily. More often than not, significant refers to statistically significant, which means that the difference between the two groups of patients was statistically meaningful and unlikely to be random.

          Statistical significance is an important concept. Without measuring the statistical significance of study results in cancer treatment, it is possible that any effects may not even be real but rather just chance. However, statistical significance is not enough. Another medical term—clinically significant—means “important to patient care.” This is what we are after. If a small effect is statistically significant, it may still not be large enough for us to care much about it. Watch out for the word significant, and assume it’s likely “statistics-speak” and not necessarily the large, important improvement you might think.

Our book explained - in a 3 minute video

If you were wondering what our book is really about, this short video will reveal all:

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

Video: abiraterone and enzalutamide for advanced prostate cancer: results from ASCO 2012 discussed

A video summary of the most important data regarding abiraterone (Zytiga ®) and enzalutamide (MDV-3100) - two of the most important new drugs in prostate cancer.  Recorded at ASCO 2012.

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

Myths and realities in cancer clinical trials: an interview with Dr. Luke

Click to listen

Interview with Dr. Luke about cancer clinical trials.  We touch on some common misconceptions and point the listeners towards resources that they will find helpful.  The original program aired on KFAB 1110AM on Sunday July 5 and is available at Dr. Luke's website.



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

Dr. Beer's radio interview: clinical trials and advances in prostate cancer

UPDATE:  the interview is now available online as a podcast.  Click here.

Dr. Luke Nordquist, who has quite a following in the heartland of the country, will be interviewing Dr. Beer this weekend.  The show will air Sunday August 5^th at 9:30-10 AM CST (7:30 AM PST) on 1110AM KFAB (www.kfab.com).

It can also be heard over the internet on www.iheartradio.com (Omaha, 1110AM KFAB), so you can catch it online even if you are out of the listening area.

We will be talking about cancer clinical trials:  what they are, how they work, and how one might learn more about experimental therapy.  It will be a fun show and all about helping people living with cancer make informed decisions about their cancer care. Tune in if you get a chance or check it out online.

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

Blind and Double Blind—Sound Ominous?

Those terms certainly sound dangerous. But in the world of cancer clinical trials they refer to methods used to make sure experimental drugs are fairly and accurately tested. Blinded studies are also called randomized studies, although not every randomized study is blinded. Just to clear the air about eye safety, the term “blinded” originated when early participants were actually blindfolded—not likely to happen today.

In many clinical trials two or more drugs are compared in the experimental process. In order to make sure all participants are treated equally, they may not be told which of two or more treatments they are receiving—experimental drug (new), standard drug (the best now available), or maybe even a placebo (see previous entries about placebos) if no standard drug exists. This is a “blind” or “blinded” study. If you participate in a blinded study you will not know and will not be able to choose which treatment you receive. This is common in clinical trials.

It is also common for a blinded study to be a “double blinded” study. This is a second step to insure that all participants and all medical procedures are as fair and equal as possible. In a double blind study not only doesn’t the trial participant know what treatment they are receiving, but the doctors, nurses, and other personnel directly administering the trial do not know either. It is possible to be unblinded and know what one is getting - although this is rare. In general, unblinding happens only if there is a severe side effect and the care of the patient requires knowing what drug he or she is receiving.  Unblinding also happens when the clinical trial is over.

While this may seem frustrating for those involved, blinding increases the chances of determining the actual benefit (if there is one) of the experimental treatment being tested in the trial. 

Ominous? Of course not. It’s all just another part of the clinical trial process.

To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Does joining one cancer clinical trial disqualify you from joining another trial?

Participating in one clinical trial does not necessarily disqualify you from future trials, as long as you meet the future study criteria. Many people participate in more than one clinical trial over time. Rules for trial participation do take into consideration therapy that you have received prior to joining a trial, and a prior treatment that you have received—either standard or experimental—might make you ineligible. If you already know you might be interested in a specific trial sometime in the future, check with your doctor or clinical trial site to see if the treatment decisions you make today could get in the way later. For the most part, however, many other clinical trials are available, and even if one particular study is off limits to you, another is likely to become available.

Waiting for the new drug to be approved…

Not all clinical trials end with a successful drug or treatment being approved by the FDA. But when the trial is successful we want the new drug to be available today—if not sooner. It seems like it takes forever for the FDA to review and finally approve a drug, especially if it’s one that might benefit us.

In a study recently published by the New England Journal of Medicine, two researchers from the Yale School of Medicine studied the average time from clinical trial to approval by the FDA in the U.S., the European Medical Agency (EMA), and Health Canada between 2001 and 2010.

Although the average approval time still may seem long, the FDA approval time was more than two months faster than the EMA and more than three months faster than Health Canada.

Average drug approval times:

FDA                            322 days

EMA                           366 days

Health Canada         393 days

Approval agencies around the world are always under pressure to approve potentially successful drugs as soon as possible and many approvals are done in less time than the averages shown here. It is worth noting also that a long approval time may mean that the study results are not as clear cut as it seems and the FDA needs to ask more questions. The other side of the coin, of course, is when a drug may be approved too quickly and then have to be recalled because of risks and problems not known at the time of approval.

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

Podcast: Drs. Armstrong and Beer discuss new prostate cancer treatments

Podcast of Dr. Andrew Armstrong and Dr. Tom Beer speaking about new treatments for the most advanced form of prostate cancer.  Listen by clicking on the MP3 icon to the left.  You can also read the text of the interview and listen to the podcast at the Cancer Network website.

To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Clinical trial phases from the participant's point of view

There are many types of clinical trials.  Most commonly, they are divided into phase I, II, III, and sometimes IV.  The phases refer to the phases of testing of a new drug in humans. Some our previous posts describe the various phases and discuss phase I trials and phase III trials in more detail.  Here we would like to share with you page 47 from our book, where we provide a succinct summary of the advantages and disadvantages of each trial type, from the perspective of trial participants.  The table shown below may not apply to every single trial, but it does give you a quick and straight forward basic guide.

If you would like to download a PDF of this page you can do so here.  Feel free to share it.

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

Dr. Beer interviewed about clinical trials

A few weeks ago, at the 2012 ASCO meeting, I had the privilage of being interviewed about about clinical trials by Andrew Schorr, Founder of Patient Power.


You may also wish to visit the Patient Power website, which is a wonderful resource.


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

Lower income reduces participation in cancer clinical trials

In a carefully documented study, sponsored and funded by the National Cancer Institute and NexCura, researchers found a surprising gap in participation in clinical trials between cancer patients with higher incomes and those with lower incomes. Nearly 5,500 cancer patients were interviewed for the study that concludes:

• Cancer patients with annual incomes under $50,000 were 27% less likely to participate in a clinical trial than those with an annual income of more than $50,000.
• Cancer patients with an annual income under $20,000 (such as many living on Social Security) were 44% less likely to participate in a clinical trial than those with an annual income of more than $50,000. Concern over possible costs was given a major factor in their decision not to participate (including co-pays, time off work, etc.).

Does this matter from a scientific/research point of view?

Researchers say yes.

• Lower participation rates in the lower income groups results in lower overall participation rates and slows the rate of completing trials and ultimately getting FDA approval for new and better treatments.
• With lower participation rates from large segments of the population trial results may not be as reliable, their results may not be fully applicable to all populations.

Does it matter from a patient point of view?

• Clinical trials can provide many benefits to participants, including access to new drugs, excellent medical treatment, and close monitoring of their health status.
• According to the study leader, Dr. Joseph M. Unger, lower income individuals already have more medical conditions and less access to healthcare than their higher income peers. Having less access to cancer clinical trials adds to this treatment gap.

Solutions?

The study recommended:

• Increased and improved education for lower income cancer patients, making sure they knew what the costs were and that costs associated with clinical trials were not significantly different from regular care.
• Increased and improved education for lower income cancer patients about the possible benefits of participating in cancer clinical trials.

Other possibilities…

• Providing transportation or transportation costs for low income participants.
• Providing the trial treatment in the participant’s home (going to them).
• Finding ways to include (more) lower income individuals who do not have health insurance coverage.

In an ideal world, all patients would have equal access to cancer clinical trials. 

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