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Clinical Trials – What You Need to Know
Featured Speaker:
Organization: MemorialCare Health System
Service: Research & Clinical Trials
Dr. Mel Marks, MD
Mel Marks, M.D. is the Executive Vice President of MemorialCare Research, an administrative and regulatory support program for clinical research in the Memorial Health system. The system includes six top hospitals – Long Beach Memorial, Miller Children's Hospital Long Beach, Community Hospital Long Beach, Orange Coast Memorial in Fountain Valley, and Saddleback Memorial in Laguna Hills and San Clemente. He is also a Clinical Professor of Pediatrics at the University of California, Irvine.Organization: MemorialCare Health System
Service: Research & Clinical Trials
Transcription:
Clinical Trials – What You Need to Know
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 and 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.
Dr. Mel Marks (Guest): Thank you.
Deborah: 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?
Dr. Marks: Clinical trials are intended to bring new discoveries, predominantly new treatments, but they can be other discoveries such as preventions, diagnostic message, 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. The importance here is that some of those processes can take several years, and some of the patients need these new discoveries today.
Deborah: Right. Who conducts these clinical trials?
Dr. Marks: Clinical trials are conducted in a wide array of sites depending on the type of condition they’re looking at. In our situation, since we have a very wide scope of services in hospital and in outpatients and clinics and doctors’ 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 discovered 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 program, so it’s an ideal site and we’re selected very often from the candidates all across the country to do these trials.
Deborah: So that’s from the professional end. Now, from the other end, who can participate in a clinical trial, and what are those benefits?
Dr. Marks: 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 to the [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 complex and rare conditions. And with the common conditions, there are 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: 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?
Dr. Marks: 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. The centers of excellence at Long Beach Memorial and Miller Children’s can focus on delivering these innovations very quickly and very early to patients. Examples are Todd Cancer Institute and our Jonathan Jaques Cancer Program. These programs that reach out to patients with cancer from a very young age, in childhood, through the entire age spectrum of life. And we have a large number of clinical trials available to 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. Those patients come from a little further field. So there’s quite an array of programs—heart, cancer, newborn and pregnant moms, and stroke patients and so forth.
Deborah: Now, is there any cost associated with clinical trials for the patient?
Dr. Marks: No. All research procedures and clinical trial study procedures, supplies, and so forth are free to the research subject. And in addition to that, there is transportation, sometimes, work loss and other expenses associated with participation. There are ways often to compensate the research subject so that they don’t have any other pocket expenses at all.
Deborah: That’s wonderful. If someone is interested in participating in a clinical trial, how can they get more information?
Dr. Marks: 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, et cetera, and they can find clinical trials in each of those areas. They can also call MemorialCare Research at 562-933-5600.
Deborah: Wonderful. What are the benefits of some of these trials to future patients?
Dr. Marks: Well, I think the major benefit is that it allows those suffering, particularly from chronic disorders and they are very common, like asthma or chronic obstructive pulmonary disease, or they maybe very rare like types of mental retardation, 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, and MemorialCare is a special place where patients in Long Beach, as an example and throughout our system, can access these clinical trials program.
Deborah: 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 much, Dr. Marks, for being on the program today.
Dr. Marks: My pleasure. Thank you very much.
Deborah: 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. 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.
Clinical Trials – What You Need to Know
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 and 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.
Dr. Mel Marks (Guest): Thank you.
Deborah: 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?
Dr. Marks: Clinical trials are intended to bring new discoveries, predominantly new treatments, but they can be other discoveries such as preventions, diagnostic message, 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. The importance here is that some of those processes can take several years, and some of the patients need these new discoveries today.
Deborah: Right. Who conducts these clinical trials?
Dr. Marks: Clinical trials are conducted in a wide array of sites depending on the type of condition they’re looking at. In our situation, since we have a very wide scope of services in hospital and in outpatients and clinics and doctors’ 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 discovered 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 program, so it’s an ideal site and we’re selected very often from the candidates all across the country to do these trials.
Deborah: So that’s from the professional end. Now, from the other end, who can participate in a clinical trial, and what are those benefits?
Dr. Marks: 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 to the [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 complex and rare conditions. And with the common conditions, there are 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: 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?
Dr. Marks: 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. The centers of excellence at Long Beach Memorial and Miller Children’s can focus on delivering these innovations very quickly and very early to patients. Examples are Todd Cancer Institute and our Jonathan Jaques Cancer Program. These programs that reach out to patients with cancer from a very young age, in childhood, through the entire age spectrum of life. And we have a large number of clinical trials available to 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. Those patients come from a little further field. So there’s quite an array of programs—heart, cancer, newborn and pregnant moms, and stroke patients and so forth.
Deborah: Now, is there any cost associated with clinical trials for the patient?
Dr. Marks: No. All research procedures and clinical trial study procedures, supplies, and so forth are free to the research subject. And in addition to that, there is transportation, sometimes, work loss and other expenses associated with participation. There are ways often to compensate the research subject so that they don’t have any other pocket expenses at all.
Deborah: That’s wonderful. If someone is interested in participating in a clinical trial, how can they get more information?
Dr. Marks: 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, et cetera, and they can find clinical trials in each of those areas. They can also call MemorialCare Research at 562-933-5600.
Deborah: Wonderful. What are the benefits of some of these trials to future patients?
Dr. Marks: Well, I think the major benefit is that it allows those suffering, particularly from chronic disorders and they are very common, like asthma or chronic obstructive pulmonary disease, or they maybe very rare like types of mental retardation, 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, and MemorialCare is a special place where patients in Long Beach, as an example and throughout our system, can access these clinical trials program.
Deborah: 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 much, Dr. Marks, for being on the program today.
Dr. Marks: My pleasure. Thank you very much.
Deborah: 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. 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.