What Are Clinical Trials?
Clinical trials are research studies that help doctors find new safe and effective medicines, therapies, and devices to prevent, diagnose, and treat diseases. They also help determine whether the treatment’s risks are worth the benefits. In the field of prostate cancer there are hundreds of trials currently recruiting patients. It is worth exploring whether there is one that’s right for you or your loved one.
Different Types of Clinical Trials
Treatment trials test new drugs, surgeries, therapies or a combination of these.
Prevention trials test new medicines, vitamins, or changes in lifestyle to find the best ways to prevent disease.
Screening trials find the best way to identify diseases, especially in their early stages.
Quality of Life trials try to explore ways to improve comfort and quality of life for patients.
Phases of Clinical Trials
Most clinical trials will pass through several phases to examine the safety and effectiveness of a drug while protecting patients. Generally, clinical trials fall into one of the following phases:
- Phase I: These studies test a new drug or treatment in people for the first time to evaluate safety, dosage amounts, and side effects.
- Phase II: A phase II trial continues safety testing and begins to evaluate how well the drug or treatment works in a larger group of people.
- Phase III: In phase III the new drug, treatment, or surgical procedure is compared to the current standard treatment. These studies typically enroll large numbers of people at multiple locations across the country. These trials confirm effectiveness, monitor side effects, and accumulate data that allows the drug to be used safely.
- Phase IV: Phase IV rials take place after a treatment has been approved by the Food and Drug Administration (FDA) and marketed to consumers. These studies continue to gather information on the treatment’s side effects, benefits and risks to ensure that it is safe and effective.
What are the benefits?
Participants may get new treatments before they are widely available. The costs directly related to the clinical trial, including treatments, tests and doctor visits are provided at no cost to the patient. This provision was included in the Patient Protection and Affordable Care Act of 2010. If a patient has unsuccessfully tried other available treatment options, a clinical trial may provide patients and families a renewed hope for successful treatment. Participants will receive care from some of the leading physicians and health care facilities in the country.
Clinical trials give doctors and researchers information to develop new treatment options and possibly save lives. Many of today’s most effective treatments have been made available thanks to previous clinical trial results. With a disease like prostate cancer that kills over 32,000 men every year these new options are desperately needed. Patients can play a more active role in their own health care.
What are the risks?
When a new treatment is being studied doctors and researchers don’t know all of the risks and side effects that may be involved. Below are a few possible risks that should be considered:
- The new treatment may not work as well as the standard treatment or it may not work at all.
- The new treatment may have unpleasant or life-threatening side effects.
- You may have to make more trips to the doctor and undergo more testing compared to the standard treatment.
How do I know that clinical trials are safe?
If you or a loved one are considering participating in a clinical trial you may have some concerns about whether they are safe and how they are monitored. However, the Federal Government has put in place several strict guidelines and measures to ensure that patient safety is put first.
First, clinical trials must follow a protocol, or plan for the study, created by the lead doctor or researcher for the trial. The protocol thoroughly explains what the trial will do, how the study will be conducted, and the importance of each part of the study. It makes certain that patients are treated exactly the same no matter where they are receiving treatment and that every doctor conducts the trial properly.
Additionally, each center that offers a clinical trial is monitored by an Institutional Review Board (IRB). An IRB must approve a clinical trial before it can begin, and members carefully watch the progress of the research throughout the study. In some trials, often larger, multi-site trials, a Data Safety Monitoring Board (DSMB) may be used. The DSMB tracks data to ensure patient safety and make sure that results are being reported completely. If they find that a treatment is harmful to patients or if one treatment is significantly better than another they may stop a study altogether or switch patients to the more effective treatment.
Remember, every participant in a trial is carefully observed by doctors to determine how the treatment is working and to track any side effects.
How do I participate in a clinical trial?
Keep in mind that clinical trials may not be right for everyone. If you or a loved one are considering participating in a clinical trial it is important to educate yourself as much as possible about the potential benefits, risks, and outcomes of the trial. You may find out about a clinical trial from your doctor or may learn about it on your own through a newspaper ad or a website.
If you find a trial that you are interested, you will want to take the following steps:
Talk to your doctor. Your doctor may be familiar with the trial or therapy that the trial is studying. She may be able to tell you whether you would be eligible for the trial and discuss some of the benefits and risks.
Contact the trial coordinator. Each clinical trial has a coordinator and their contact information is usually listed in the trial announcement. Either you or your doctor can speak with the coordinator about whether you meet the criteria for the study and ask any remaining questions you may have.
Screening. You will schedule a time for a pre-trial screening in which you’ll undergo tests to make sure that you qualify for the study. You will also get a chance to speak further with investigators about the trial.
Co-pay Card Programs
Making sure that patients have access to affordable, high-quality health care, including prescription medicines, is vital for the health of the U.S. population. Patients are sensitive to medication costs and some will avoid using medication if out-of-pocket costs are too high. Co-pay card programs offered by biopharmaceutical companies are a direct way to lower eligible patients’ out-of-pocket costs so they can afford the medications preferred by them and their physicians.
Preserving medication choice is critical to making health care accessible, effective, and affordable. Co-pay programs can help physicians make prescribing decisions based primarily on clinical outcomes since patient financial barriers are addressed.
Listed below are some of the most frequently asked questions about co-pay card programs.
What are prescription drug co-pay cards?
Co-pay card programs offered by drug manufacturing companies are a direct way to lower out-of-pocket costs for prescription drugs for eligible patients. The cards can enable patients to afford the medications preferred by them and their physicians.
Who is eligible to enroll in co-pay card programs?
Patients with commercial/private insurance are eligible to enroll in the program. Co-pay cards are usually not need-based.
Where do I learn about co-pay card programs?
Ask your doctor or check with your local pharmacy. You can also check your medication’s Web site or visit patient assistance sites such as www.NeedyMeds.org.
How do I enroll?
It’s easy. If your doctor has given you co-pay card information with your prescription, fill out the application and send it to the drug manufacturer. If you learned about the program on-line, follow the enrollment process.
How do I ‘redeem’ a co-pay card?
Once enrolled in a co-pay card program, the patient provides his/her co-pay card and prescription to a pharmacy where the pharmacist enters the information into their system to submit a claim.
The pharmacist is required to enter the patient’s insurance number in the primary field and an identifier from the co-pay card into the secondary insurer field. The patient is instantly provided with coverage data, relaying the patient’s out of pocket costs, or co-pay to the secondary insurer’s benefit manager, who then provides a discount accordingly. The pharmaceutical company pays for the program’s cost, including the difference in the patient’s cost.
Can co-pay cards be used with insurance?
Yes. Co-pay cards are designed specifically to help with insurance co-payments.
Do I need to have a particular type of healthcare/insurance plan to be eligible for co-pay cards?
No. Any commercial/private insurance plan offering prescriptions may use eligible co-pay cards. Your eligibility depends on the terms of the specific brand co-pay card program and your insurance plan.
Where can co-pay cards be used?
Co-pay cards may be used in local pharmacies and are also accepted by certain mail order pharmacies.
What is the duration of co-pay card programs?
The duration of co-pay programs varies. The expiration depends on the parameters outlined by the pharmaceutical company providing the co-pay card.
What prescription drugs are offered with co-pay cards?
Most co-pay card programs are designed for more expensive prescription drugs, but some other older or less expensive drugs have cards as well. It is best to check with your physician or pharmacist or on-line to see if your medication has a co-pay program.
Are there any restrictions on the use of co-pay cards?
Yes; they cannot be used with Medicare and Medicaid. Prescriptions eligible to be reimbursed, in whole or in part, by any federal or state health care programs cannot use co-pay cards.
Do co-pay cards increase patient compliance?
By helping patients better afford the medicines prescribed by their doctors, co-pay programs improve adherence, particularly among elderly and lower income patients. They also reduce costs arising from patient non-adherence, such as emergency room visits and hospitalizations.
How do patients and healthcare professionals benefit from co-pay card programs?
Co-pay cards help lessen patients’ financial burden making it more likely that individuals will fill their prescriptions. Offering co-pay cards for prescription medications provides patients and healthcare professionals with increased flexibility and choice to ensure the appropriate treatment option is chosen and attainable by the patient. In addition, some co-pay card programs offer educational material for patients, providing an opportunity for greater understanding their condition and treatment.
Men at Work
A flag-ship program in which MHN serves as the primary men’s health partner with employers in terms of corporate wellness activities and health events for their employees. Since 2001, MHN has secured relationships with over 60 corporate employers including John Deere, Harley Davidson, Anheuser Busch, Miller Brewing Company, UPS, Lockheed Martin, NASA, Eastman Chemical Company, Ford, GM, Chrysler, and many more.
Healthy Sunday Initiative
Men’s Health Network partners with church pastors and parish nurses (train the trainer) in coordinating a series of church health screenings and education on Sundays as a part of the Healthy Sunday initiative. The initiative utilizes trusted communications vehicles such as newsletter, bulletin, and community calendar, and more
Time Out for Men’s Health
Time Out for Men’s Health is a national awareness campaign to educate men about the importance of regular check-ups and age-appropriate screenings. “Just like taking the car in for an oil change or for the 25,000-mile checkup, men also need to take themselves to the doctor’s office to make sure everything is running smoothly,” David Gremillion, MD, of MHN said. “That’s why MHN created this campaign – to help men keep track of how often to check their blood pressure, get a tetanus booster and check their testosterone levels.”
MHN has worked with a broad range of retail/consumer corporate partners such as Publix, Sports Authority, Simon Malls, Target, and others to conduct sponsored health education and screenings for its customers in local markets.
Men’s Health Month & National Men’s Health Week
June is Men’s Health Month and the week that ends on Father’s Day is a special period recognized by Congress as National Men’s Health Week (NMHW). NMHW was signed into law by President Clinton in 1994. Each year, MHN asks that Governors declare Men’s Health Week in their states. For more information on Men’s Health Month and National Men’s Health Week please visit menshealthmonth.org.
Symposia & Conferences
MHN produces national conferences, state and city symposia, and panel discussions on a broad range of topics, including policy, men’s health, mental health, veterans, prostate cancer, smoking, parenting, and more. Visit our conferences page to learn more about upcoming and past events.
Utilizing our Board of Advisors, over 800 leading physicians and experts in men’s health issues, we provide speakers and panelists to partner organizations. Our advisors are able to reach men in a meaningful way with health messages, programs and care.
MHN has an extensive publication portfolio designed to inform men and their loved ones about important prevention and health care needs. These include the well-regarded book, Blueprint for Men’s Health, Your Head: An Owner’s Manual, Heartbeat: Cardiovascular Disease: What you can do to improve your heart health, and numerous brochures on a variety of subjects including prostate cancer, BPH, testicular cancer, cholesterol and others specifically designed to inform women about men’s health needs. In addition, the American Journal of Men's Health (Sage) is published in association with Men's Health Network.
Men's Health Network Online Support Community
Men's Health Network is proud to partner with Inspire, the leading social network for health, to offer a safe place for patients and caregivers to connect and support one another on a variety of topics such as prostate health, low testosterone, and sexual health.
Men's Health Network is proud to partner with Theravive, a network of licensed therapists and psychologists committed to helping people receive the best mental health care available. Through building bridges with others, Theravive continually strives to lower mental health stigma.
MHN Testicular Cancer Online Support Community
Men's Health Network is proud to partner with Inspire, the leading social network for health, to offer a safe place for patients and caregivers to connect and support one another around the prevention, detection, and treatment of testicular cancer.