The results from a survey on clinical trials reveal that only 5% of women diagnosed with a gynecologic cancer are aware of clinical trials. This is much lower than the 15% of women diagnosed with breast cancer. Included below is a graph from that study.



From "Clinical trials awareness and attitudes in cancer survivors (Ca surv)" by R. L. Comis, D. Colaizzi, J.D. Miller; Coalition of Cancer Cooperative Groups, Philadelphia, PA; Northwestern University, Chicago, IL. As presented at the American Society of Clinical Oncology Annual meeting on June 5, 2006, Abstract No: 6061 Poster No: H1.

This graph shows the rate of death due to different types of cancer for the past 76 years. While the death rate from other female cancers such as breast and uterus have had a dramatic decrease, the rate of women dying from ovarian cancer (gold line) has remained relatively unchanged for the past 35 years!

A group of physicians conducted a study to answer this question. They concluded that "women with ovarian cancer who participate in clinical trials at this institution have improved survival compared with those who are treated with standard therapies". To read a summary of this study go to this <link>.

Many clinical trial websites discuss these issues. The Coalition of Cancer Cooperative Groups, a nonprofit organization with the mission of improving the cancer clinical trials system, has a page devoted to this topic on its <website>.



THE FOLLOWING IS A TRANSCRIPT FROM AN OVARIAN CANCER CLINICAL TRIALS TELEPHONE CONFERENCE SPONSORED BY THE FOUNDATION FOR WOMENS CANCER, March 9, 2015.

Debbie Miller provided the following patient's perspective:

I would also like to thank the foundation for the opportunity to present the survivor response for this very important topic. I would also like to thank Dr. Monk for his work. He is very passionate about ovarian cancer trials. I have actually had the opportunity to watch him in action as he is developing these clinical trials through NRG Oncology and GOG.

My story is very similar to most of the other survivors on this call. Eight years ago I woke up from a debulking surgery and was given the diagnosis of ovarian cancer. But this is where my story is a little different. I asked my physician to find me a clinical trial, I simply for some reason decided that I wanted to fight this disease within a clinical trial.

So I joined a front line clinical trial which is for women that are newly diagnosed. These trials are for women that have had no treatment yet for their ovarian cancer. I began to meet other women with this disease, which I've met quite a few in the last eight years. I soon learned that most of the survivors were not clinical trial participants and I wanted to learn more about clinical trial research. I would like to share some of the interesting things that I learned with survivors that are on this call.

One thing I found out was that according to a survey conducted in 2006 that involved quite a few numerous cancers, it was interesting that only five percent of women diagnosed with a gynecologic cancer were even aware of clinical trials. This I found extremely surprising. But as a result of that, we only see about three to five percent of adults with cancer participating in clinical trials. And as a result, many of our trials in ovarian cancer take months, and sometimes even years to accrue enough patients to determine if that trial is effective. And I find that very disheartening. But on the other hand, when you compare childhood cancers, over 60 percent of kids, and it's probably closer to 80 percent of kids with childhood cancers participate in clinical trials. And the survival rates for these kids have increased from 50 percent 30 years ago to 80 percent today. Some researchers have stated that this progress is due to the large majority of kids on clinical trials. So the question is for us as survivors is could we move quicker to better treatments with higher participation levels? Imagine what might happen if clinical trial participating was the new standard of care of women with ovarian cancer like it is for kids? Something I think about quite often.

The next thing I wondered about is if women do better on clinical trials? And Dr. Monk has already talked about this, but I actually did find a medical journal article that was published in 2009 by a group of GYN oncology physicians who found that their patients who participated in clinical trials did have better outcomes than those that did not. I found that study extremely interesting, and something that was actually in print.

So as I really got involved in clinical trials I began actually serving on gynecological cancer clinical trial committees as a patient advocate, and there are several things that I learned that I would also like to share with some of the callers today. When Dr. Monk talks about clinical trials, NRG Oncology, formerly GOG has really moved treatments for this disease so dramatically within the past. Dr. Monk can correct me on this, but I think 30 plus years, maybe 40 years. It's been amazing what this group has done.

But as I've sat on these committees in the last few years, there is quite a lot of detail that goes into the design of these trials. The principal investigators talk about safety guidelines and about toxicities in several committees; it's not just one committee. So there is a lot of input that goes into the design of these clinical trials. Included on these committees are physicians including general oncologists, GYN oncologists, pathologist, radiologists, the list goes on and on. Healthcare providers, statisticians as well discuss in depth these clinical trials. It's important all these professionals are included so we have a high degree of assurance of the clinical result that we're studying. I've also learned how important patient advocate and survivor input is on clinical trial development. We are always asked our opinions about the perspective concepts and we also have a vote on approval of these trials.

Dr. Monk also mentioned something I found extremely important when he talked about histology. Knowing the histology of your ovarian cancer. I can't tell you how many times I've asked women what type of ovarian cancer they have, and they will say like Dr. Monk said, epithelial. It's important that you know more specifically the histology of that disease, because now within the last few years, we have clinical trials for rare tumors. We have clinical trials for specific types of ovarian cancer, and if you're going to begin to look at trials, that's the first thing you need to know is what type of cancer that you have. Another thing that I learned is that in most phase two and phase three clinical trial concepts, there is quite often an eligibility statement about how many previous treatments a woman can have, and many times this is one to two previous treatments. So it makes more difficult to participate in some of these trials if you've had numerous therapies.

In addition, for an example, if I had had a drug like Avastin like Dr. Monk mentioned this drug, I most likely would not qualify for a trial with this drug or similar drugs. So remember, it's easier to go back to standard of care treatment after a clinical trial than it is to participate in many clinical trials when you've had multiple treatments. When talking with other survivors, I'm always moved by women who regret they did not participate in a clinical trial or when a woman says she was told that she could always get on a clinical trial. So this is something that women really need to know.

Something else I think is interesting. There are other types of clinical research that survivors can participate in that do not include treatment, and these are oftentimes just an important. Let me give you two just very quick examples. These studies are open by the way. One is being sponsored by the Department of Defense. It's a consortium project that is investigating long term survivors - 8 years or more. And it involves a survivor completing a survey and signing a release so that tissue from her surgery can be analyzed. This is called DOD Ovarian Cancer Outcomes Consortium. If you want Google that to find information about that particular study.

The second one is GOG study. It's a diet and physical activity trial. If you are a newly diagnosed survivor and have just completed your treatment, this study is open at over 300 sites in the United States. And it's for women who have completed their first therapy. On the foundation website there is a link to this. Its reference is GOG225. Often times women will say I want to be involved in clinical trials, but I'm in treatment, so there are studies like this that women can become involved.

During my journey I've learned that there are many reasons why women do not participate in clinical trials, and Dr. Monk has mentioned some of these. Financial reasons, their physician may not have access to clinical trials, or women may have difficulty finding information about clinical trials. So I decided there was really not a lot I could do about two of those things, but the third one, the information one was something that I felt compelled to do. I wanted to make it easier than waking up from surgery and asking your physician to find you a clinical trial; maybe your physician doesn't do clinical trials. So I asked other survivors to help me by providing feedback on the development of a website, the result of which was a website designed by survivors for survivors, and it's called ovariancancertrials.org.

This site makes it simple for women to find ovarian cancer trials listed on the clinicaltrials.gov database by state. So simply click on a link, it opens all the open, available ovarian cancer trials in your state. Also on the site are videos and articles. The information that I talked about previously and links are on that site as well as videos on the benefits of clinical trial participation including two by Dr. Monk. On this site you can print out information on individual trials, and hopefully it will be easier for survivors to start a conversation with their physician about clinical trials in the event you haven't done so yet. It also includes a phone number about information about on specific trials, and you can make that call. If you see a clinical trial that you're interested in, there is a phone number there, that phone number goes to a clinical trial coordinator, and they are most happy to talk with any survivor about that clinical trial. And don't be discouraged if that trial is closed. Keep in mind that this data is live information and it's always changing. Other sources of information Dr. Monk mentioned is the Foundation which has an amazing site also on clinical trials. They have a link to a group called Coalition of Cancer Cooperative groups which includes clinical trials matching specialists that will help you match with a clinical trial in the event you wanted to talk with somebody. And good information is also available on both ovarian cancer national websites, OCNA and NOCC, as well as on the clinicaltrials.gov website.

So finally, when deciding to participate in a clinical trial, ask questions, take time to consider all of your options, and make the decision that feels right for you. That concludes my presentation and I'd like to leave time for questions.