Clinical Trials – What You Need to Know

Intro: This is Weekly Dose of Wellness brought to you by MemorialCare Health System. Here's Deborah Howell.

Deborah Howell (Host): Hello and welcome to the show. You're listening to Weekly Dose of Wellness brought to you by MemorialCare Health System. I'm Deborah Howell and today's guest is Dr. Mel Marks, Executive Vice President of MemorialCare Research, an administrative and regulatory support program for clinical research in the Memorial Health System, which includes six hospitals in Southern California. He is also a Clinical Professor of Pediatrics at the University of California, Irvine. Welcome, Dr. Marks.

Mel Marks, MD: Thank you.

Deborah Howell (Host): Today we're going to talk a little bit about clinical trials. We hear so much about them on TV and radio, so let's find out a little bit more about what they entail. First off, what is a clinical trial?

Mel Marks, MD: Clinical trials are intended to bring new discoveries, predominantly new treatments, but they can be other discoveries such as preventions, diagnostic methods, devices, and so forth, to patients who may need to access these new discoveries even before they are available through normal channels. In other words, before the government has completed all of its trials and safety tests and approval processes. And the important point here is that some of those processes can take several years, and some of the patients need these new discoveries today.

Deborah Howell (Host): Right, right. So who conducts these clinical trials?

Mel Marks, MD: Clinical trials are conducted in a wide array of sites depending on the type of condition that they're looking at. In our situation, since we have a very wide scope of services in hospital and in outpatient clinic and doctor's office facilities, we can actually provide clinical trials in all of those sites and take care of patients at all ages and in wide geographies. For those reasons, we have been selected many times by those who discover these new treatments or interventions. And the selection of organizations and individuals to conduct the trials are really based on their ability to reach out successfully to patients, their reputation and experience in clinical excellence, and their ability to support these research studies in an accurate, expeditious, and timely fashion, and also to make sure that the research subjects are completely protected in terms of their safety and their other rights to confidentiality and so forth. And MemorialCare has all of these structures built into their clinical trials programs, so is an ideal site, and we're selected very often from candidates all across the country to do these trials.

Deborah Howell (Host): So that's from the professional end. Now from the other end, who can participate in a clinical trial and what are those benefits?

Mel Marks, MD: That's a good question. The population served by the MemorialCare Health System is very large and diverse and extends over two counties. So many of our patients, I would say most of our research subjects, come from within that geography in Orange County and South Los Angeles County. However, any person out there in the public, and sometimes a far field, can participate in these trials if they have the specific condition and other eligibility criteria. So really this is open to individuals who may have common or very, very complex and rare conditions. And with the common conditions, there's usually quite a few patients right in this immediate vicinity, but with the rare conditions, sometimes our research subjects volunteer for these studies from very far away.

Deborah Howell (Host): Right. So how many clinical trials or research projects do Long Beach Memorial and Miller Children's offer, and what are some of the topics of those trials?

Mel Marks, MD: These two facilities together, since they cover all age groups from birth really through senior care, can provide new discoveries to patients and other persons in quite a large number of conditions. So that the centers of excellence at Long Beach Memorial and Miller Children's can focus on delivering these innovations very quickly and very early to our patients. Examples are our Todd Cancer Institute and our Jonathan Jaques Cancer programs. These are programs that reach out to patients with cancer from very young age in childhood through the entire age spectrum of life, and we have a large, large number of clinical trials available for cancer patients. We also have at Long Beach Memorial and Miller Children's innovative heart programs for clinical trials of new modalities to treat, diagnose, and sometimes sustain good quality of life in patients with heart disease, and so forth. The Children's hospital has an array of very specialized centers for the more uncommon conditions like cystic fibrosis and autism and so forth, and clinical trials are conducted very frequently in those centers as well. And those patients come from a little further afield. So there's quite an array of programs: heart, cancer, newborn and pregnant moms, and stroke patients, and so forth.

Deborah Howell (Host): Now is there any cost associated with clinical trials for the patient?

Mel Marks, MD: No. All research procedures and clinical trial study procedures, supplies, and so forth are free to the research subject. And in addition to that, if there is transportation, sometimes work loss, and other expenses associated with participation, there are ways often to compensate the research subjects so that they don't have any out-of-pocket expenses at all.

Deborah Howell (Host): Oh, that's wonderful. Now if someone is interested in participating in a clinical trial, how can they get more information?

Mel Marks, MD: They can go to the MemorialCare website, www.memorialcare.org, and click on "Services" and then click on "Research and Clinical Trials." Under that heading, they will find a grouping of conditions from heart disease through breast cancer, etc., and they can find clinical trials in each of those areas. They can also call MemorialCare Research at 562-933-5600.

Deborah Howell (Host): Wonderful. What are the benefits of some of these trials to future patients?

Mel Marks, MD: Well, I think the major benefit is that it allows those suffering particularly from chronic disorders - and they may be very common like asthma or chronic obstructive pulmonary disease, or they may be very rare like certain types of mental retardations, Fragile X, cystic fibrosis, and so on - it allows those folks to actually seek immediate and early access to new discoveries. The rate of discoveries now, particularly for drugs and devices, is so rapid that today's patients can benefit from those discoveries much sooner than the long, arduous process of getting these discoveries, if you will, through a traditional retail, sales, and marketing type of arrangement. So the biggest benefit is the early access to new discoveries that may help the patient today, rather than having to wait a long period of time. Now they wouldn't be able to get this access at most places, hence MemorialCare is a special place where patients in Long Beach as an example, and throughout our system, can access these our clinical trials programs.

Deborah Howell (Host): Well, it sounds like a fantastic program you have there, and it sounds like it's helping so many people. We want to thank you so, so much, Dr. Marks, for being on the program today.

Mel Marks, MD: My pleasure. Thank you very much.

Deborah Howell (Host): It's been great, great talking with Dr. Marks about some of these clinical trials. Of course, if you want to hear the podcast again or to get more information, you can visit memorialcare.org. That's memorialcare.org. I'm Deborah Howell. Join us again next time, we'll be exploring another Weekly Dose of Wellness brought to you by MemorialCare Health System. We hope you have a wonderful, safe, and healthy week. Thanks so much for tuning in, and have a fantastic day.