15 Questions with Ken Getz - Clinical Trials
Kenneth A. Getz is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public awareness of the clinical research enterprise – and a Senior Research Fellow, Assistant Professor at the Tufts Center for the Study of Drug Development where he studies R&D management and operating models, investigative site, outsourcing, and study volunteer trends and policies. Learn more about Ken Getz here.
1. What and how would clinical trials help?
Clinical trials help research professionals, health professionals and patients. Clinical trials provide patients with the opportunity to play an active role in helping researchers answer important medical questions about a specific disease and discover new treatments. Through clinical trials, researchers learn how to make drugs and treatment more effective and safe. Clinical trials would not be possible without the participation of study volunteers.
2. What are clinical trials?
A clinical trial is a research study that directly involves human participants. Clinical trials are conducted so that researchers can answer specific medical and scientific questions; often about the effectiveness or safety of a drug or therapy. Carefully conducted clinical trials are the safest and fastest way to find treatment that works in people and new ways to improve health.
Clinical trials are conducted according to a plan called a protocol. A protocol includes information on: who can volunteer for the study, what drug is being tested, the schedule for the trial, and how the outcome will be measured. Study volunteer must give informed consent before participating in the trial and agree to follow the protocol.
3. Why are clinical trials done?
There are several reasons why clinical trials are conducted:
• To see if a new drug or device is safe and effective for people to use
• To compare existing treatments to determine which is better
• To study different ways to use standard treatments
• To learn how to best use a treatment in a population that was not previously tested
4. Where can people find out about clinical trials?
There are many sources for information about clinical trials and about opportunities to participate. The Center for Information and Study on Clinical Research Participation (CISCRP) is a non-profit dedicated to educating the public about the role of the study volunteer in the clinical research process. You can contact CISCRP to learn more about their educational materials at 1-877-MED-HERO or visit the website, www.ciscrp.org.
To learn about participating in a clinical trial, you can visit www.ClinicalTrials.gov, www.CenterWatch.com or www.SearchClinicalTrials.org. If you need help conducting a search, staff at CISCRP (1-877-MED-HERO) can do a customized search for clinical trials for you.
Our motto is ‘Education before participation!’ learn as much as you possibly can so that you can make informed decisions about whether participation makes sense and where you might participate. If you have a chance, you might take a look at my book – The Gift of Participation (on Amazon.com or call CISCRP at 617-725-2750). It provides a step-by-step guide for people who want to learn about clinical research and participation.
5. What types of clinical trials are available?
There are many types of clinical trials available such as:
• Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
• Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health conditions.
• Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
6. Who should consider clinical trials and why?
If you want to help research professionals answer important questions about medicines and treatments that may ultimately help patients in the future, you should consider participating in a clinical trial. By participating, you are helping advance science and helping researchers find better treatments. If you are suffering from a medical condition and have found that standard treatment is not helping you, you may want to participate in a clinical trial. You should understand that the treatments in clinical trials are experimental; researchers are still learning about their safety and effectiveness. However there is a chance that the experimental treatment will help your condition improve. There are both risks and benefits to participating in a clinical trial.
7. Where are clinical trials conducted?
Clinical trials are conducted all around the world. There are more than 100,000 clinical trials with active patient participation globally each year. These trials are conducted in academic medical centers, the offices of independent physicians, clinical research centers, hospitals, and local health clinics.
8. Are clinical trials safe?
There are both benefits and risks to participating in a clinical trial. Some of the risks include unpleasant, serious, or even life-threatening side effects resulting from the treatment. However, clinical research is regulated by rules set by the federal government to make clinical trials as safe as possible for study volunteers. Researcher must follow the protocol, the study plan, which contains many safeguards to protect participants and ensure that they will be treated safely and ethically. During the trial, researchers carefully monitor all volunteers and report any changes in the plan, serious adverse events and other results.
9. What are the different phases of a clinical trial?
In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
10. What should people think about before joining a clinical trial?
People should learn as much as possible about the clinical trial and feel comfortable asking questions before agreeing to participate. Key questions to ask before participating in a clinical trial include:
• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• What kinds of tests and treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?
11. How safe is it to be in a lupus flare and in a trial? Are you able to stay on your medication you are taking or do you need to get off everything? Garden Grove, CA
All clinical trials have risk and benefits. And you should definitely ask the clinical research staff about what risks exist before agreeing to participate. You should also talk with your primary doctor and nurse about clinical trials that you are considering. In regards to your question about if you can stay on the medication you receive in a clinical trial after that trial ends – the answer is that it depends. It is an excellent question and a good one to ask directly to the clinical staff running a lupus trial.
12. Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
13. Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
14. What should I bring up with my doctor if I want to be in a clinical trial?
If you are considering joining a clinical trial, you should first discuss any concerns you might have about participating in clinical research with your doctor. Important questions to ask include the type of care to expect while in a trial, how clinical trials work and the cost of the trial.
15. Where can I find out more about clinical research and studies specific for lupus?
A good place to start is by searching for Lupus clinical trials on www.ClinicalTrials.gov, www.CenterWatch.com or www.SearchClinicalTrials.org. You can also contact the Lupus Foundation of America to ask about trials [editor's note: please visit our Center for Clinical Trials Education to learn more.] If you need help doing a search, you can contact CISCRP, The Center for Information and Study on Clinical Research Participation, at 1-877-MED HERO.