Jan 3, 2015

The Right Clinical Trial for You—Part 3




 What Should You Expect from the Clinical Trial?
You should be comfortable and know you will be treated well when you participate in a trial. You certainly hope the trial will be a success and your cancer will be managed (or even cured, but that is unlikely), but you know that there are no guarantees. What you can expect is that your health and cancer status will be monitored closely, that side effects will be managed expertly, and that study doctors and staff will be responsive to your questions and needs. If a drug is not currently approved for use, the drug will be provided free of charge. Some of the tests you will undergo, those done specifically for the research process (e.g., extra biopsies of your cancer or blood samples to measure drug levels), are also provided to you free of charge in most cases. In most clinical trials the routine parts of your care (that would be done if you were getting standard treatment) are not provided free of charge, but are billed to your insurance provider.

What can I expect from my doctor and investigative team?
You can, and should, expect close attention by a team that is often larger than what you would encounter during routine care.
You can certainly expect exceptional care from the whole team. You will almost certainly get more medical attention than if you were on standard care. You should get regular reports about your progress. If you don’t‑‑ask! You’re getting treatment for your cancer and you’re also helping the investigators. You’re a partner in the trial. Be sure to ask, early on, who is the right person for you to contact for specific concerns. Who should you call if you have a question about a scheduling matter, and who do you call if you are not feeling well, have a new side effect, or if you have a medical question? Having that information clarified from the start and having all the right contact information for your research team can go a long way in making the process run smoothly and comfortably for you. You will almost certainly get more medical attention than if you were in standard care. You should get regular reports about your progress. If you don’t—ASK! You’re getting treatment AND you are helping the investigators.

Am I free to quit if I want to?
YES! You agreed to participate, but you always have the right to quit, whether due to side effects or if you’re not comfortable with the trial or for any reason you choose. Talk to your doctor and your trial team before you decide. They may be able to resolve your concerns and answer your questions so you will be able to stay in the program.

What if I have side effects? How will I know if I should be concerned?
A new physical or emotional sensation that is out of the ordinary for you could be an adverse effect. Tell the nurse and doctor about it right away. It is better if you tell them sooner rather than later. There may be ways to manage your side effects. It may also turn out to be unrelated to the trial and could be treated separately while you continue in the trial.
All of this is important because an adverse effect from an experimental drug is different from ordinary side effects, mostly in that less is known about it. It could start out mild and get worse over time if not attended to; sometimes this can happen very quickly. It should be brought to the attention of the research team promptly so they can be evaluated.

Bottom Line
1      Clinical trials are tightly regulated and closely supervised by the study team, institutional committees, independent boards, pharmaceutical companies, and the government. The scrutiny is far more extensive than that of routine cancer care.
2      Most of your cancer care while you’re participating in a study will be billed to and covered by your health insurance. Items that are purely for research, and not done to take care of you, are generally provided free of charge.
3      It is important to establish and maintain clear communication with your entire study team:
A     Find out which members of the team are the right contacts for different types of questions and concerns.
B     Let your study team know about adverse effects (side effects) or concerns promptly.
C     Don’t try to solve problems that arise on your own or wait until your next appointment‑‑contact your team whenever you need to.
4      You are always free to stop being a part of the study. If you are thinking about stopping, be up front with your doctor and research team. You may learn that they can solve the problems or address your concerns without stopping the study treatment.
5      Seek the support of your oncologist, your primary care doctor, your spouse, and those around you while you are making decisions about whether to sign up for a study and while you are participating in the trial.

 

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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Dec 18, 2014

The Right Clinical Trial for You--Part 2


What are the Costs of Clinical Trials?  

When you think about the costs of a clinical trial, you may be thinking about the costs of your care in a clinical trial. These costs are called clinical care costs, things like lab tests, scans, etc. As expensive as those may be, these actually are only a fraction of the total costs of the study. The people who work to make clinical trials a reality are the largest expense. Study coordinators, study nurses, and investigators are the folks you are likely to meet. Pharmacists, laboratory technicians who handle your blood specimens, regulatory specialists (who make sure the trial has all the necessary approvals), and all the people who oversee the clinical trial process and make sure it is being done correctly are working in the background; you will probably never meet them. That seems like a lot of people, but that is only the tip of the iceberg. These are just the people working at the one hospital or research center you are visiting.

There is another large group of people at the pharmaceutical company (or subcontracted by the pharmaceutical company) who develop the study procedures, receive, review, and analyze the results, monitor all side effects, disseminate information to all the researchers (for example, new serious side effect information has to be circulated quickly to everyone who is involved), and interact with the FDA. As you can see, behind every clinical trial, there is an army of people and it all costs a small (or even a large) fortune.

So Who Pays for all This?
That might be interesting, but it’s probably a safe bet that you care most about the clinical care costs that will affect you. In general, items that are solely for research (i.e. the study drug and highly specialized tests that would not otherwise be done to take care of you and your cancer) are covered by the study budget and are free to you. All other costs of medical care; the sorts of things that you would generally expect to need even if you were not in a clinical trial, are billed to you and your health insurance. 
 
The costs of running the study are borne by the pharmaceutical company for trials that are sponsored by a company. Not all studies have an industry sponsor. Some research ideas, although important, are unlikely to be tested by a pharmaceutical company. For example, if we find that a commonly used drug that is generic (and cheap) could have a beneficial use in cancer therapy, there is almost never a pharmaceutical company that is willing to get involved. The lack of patent protection and inexpensive cost of generic drugs makes this type research a lousy business proposition. 

 Such studies are typically designed and led by an individual researcher. The investigator must also find the funding to support it. Sometimes that involves a grant from the pharmaceutical industry, a grant from a federal source (most commonly the National Cancer Institute or Department of Defense), or a grant from a private organization such as the American Cancer Society. Some studies are funded by philanthropic donors or even the hospital itself. And some studies have no funding at all. Normally such studies would just not get done, but what often happens is that the investigator’s team donates their time. University administrators frown on unfunded studies because the people involved still get their salaries‑‑from the university. Academic professors can be quite innovative about these sorts of things when they are truly excited about a new idea.

Costs of Your Care and Insurance Coverage of Cancer Clinical Trials
 Everyone worries about costs
Misconceptions and concerns about healthcare costs during cancer clinical trials are very common. Some patients (and some doctors) think that experimental treatment is always free. This is almost never true. There are some studies that do provide all of the care for free, but in the world of cancer research they are more often the exception than the rule.

For the studies that you would be interested in, those that seek to treat your cancer, your health insurance will be billed for many elements of your care. It is always spelled out in the consent form; but it may be difficult to sort out. Check out the fine print and ask a health professional for help if it seems confusing.

Is your health insurance willing to pay? If so, how much? Is there a chance that you will get stuck with the bill? It could happen, but much can be done to prevent this if you are proactive. Until all patients with cancer can expect a reliable cure, well-designed clinical trials should be part of standard care. Unfortunately there is no single answer that fits everyone. Read on to learn how you can make sure that there are no financial surprises in your clinical trial.

Medicare Comes Through
If you are over the age of sixty-five, chances are Medicare is a part (or even all) of your health care coverage. Many insurance companies follow, to one extent or another, the approach that Medicare takes in deciding what it will cover and what it won’t.

Since the year 2000, Medicare covers the routine costs of qualifying clinical trials. In addition, Medicare covers costs of diagnosing and caring for complications arising from participation in all qualifying clinical trials. As with all legal matters, it is worth understanding the key definitions.

Routine costs are those items and services that are generally available to all Medicare beneficiaries. That would include doctor visits, routine labs, scans, and tests necessary to monitor your condition. Medicare also covers the costs associated with the giving of the experimental agent (not a big deal if it’s a pill but if it’s an IV infusion this can become expensive and it’s good to know it’s covered). If Medicare doesn’t cover something normally (i.e. cosmetic surgery), it would not cover it while you are a part of a clinical trial. Medicare does not cover the experimental drug or device itself (the actual pills, for example) and items or services that are used solely to gather and analyze research data and are not being done to take care of the patient (like blood drug levels or exploratory tests).

Most of the time these definitions are pretty clear. One gray zone is a situation where something that is routinely done is required more frequently during the study than would be done ordinarily. Let’s say a study wants a CT scan twice a year, but if you weren’t in a trial, you’d most likely only get one a year. This is a gray area because, in most cases, there is not an absolute standard for how often patients need blood tests or scans when they are receiving care for cancer. Some situations require more frequent monitoring than others. Some doctors (and some patients) prefer more frequent monitoring than others. The Standard is really a range of how doctors actually practice. There are situations where something that would ordinarily be considered quite routine is done so frequently in a study that it won’t be covered by Medicare. Your research team and the institutional oversight committee (IRB‑‑see chapter 9) are expected to pay attention to these matters and identify situations where Medicare or your insurance won’t pay. In these situations, the trial sponsor would usually be expected to pay; you’ll obviously want to know in advance if it’s going to come out of your pocket.

If you notice that the study you are considering requires very frequent tests, ask about it. Check in with your study team about the costs of those tests and who pays for them. Many institutions develop tables called Costs of Care or Clinical Billing Schedule tables for each study. These tables spell out every planned item and service that is a part of the study and make it clear if that particular item will be provide free of charge or billed to your insurance.

The Bottom Line
·        1 Until standard cancer therapy is much more effective and reliable cancer cures are common, participation in clinical trials should be an option for all cancer patients.
·         2 Medicare covers routine costs of care for patients who participate in qualified clinical trials. The investigational drugs or devices themselves and procedures that are purely for research purposes (not designed to care for you) are not covered. Services that would not normally be covered under Medicare are not covered.
·         3 Many insurers have policies that provide for similar coverage, but this varies from plan to plan and state to state.
·         4 The majority of states have now passed laws that require coverage for clinical trial participants.
·         5 The Health Care Reform Act of 2010 requires all health plans to cover clinical trials by January 1, 2014.
·         6 Large companies that are self-insured are regulated by the federal ERISA law and may not be impacted by state laws. ERISA does not address clinical trials.
·         7 Your research team should communicate with your insurer to gain approval for your coverage before you begin participation.
·          8 If you are denied coverage, work with your doctor and research team to appeal. Appealing with knowledge of your insurer’s policies, your state’s laws, and the particulars of the trial in which you are interested has the best chance of success. A call from your doctor to your insurance company’s Medical Director can also be very helpful.


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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Dec 4, 2014

The Right Clinical Trial for YOU—Part 1


More than 14 million Americans have cancer. At any given time, there are literally thousands of cancer clinical trials available. These studies are most often at or near large medical centers or universities. Many ongoing trials are unable to find enough participants. If the studies testing new treatments aren’t completed we all lose--new treatments don’t become available to the people they might help. How can this happen?

The facts
·         The pharmaceutical companies are interested in testing, proving, and marketing new treatments. Their mission and business success depends on successful development of new drugs. They want the medication to work.
·         The hospitals and doctors want the drugs to be effective so they can help patients. They are responsible for conducting trials of new drugs under strict controls to safeguard patients and to determine the effectiveness and safety of the drugs and treatments. They want the medication to work.
·         You are interested in managing or curing your cancer. You want a treatment or drug without nasty side effects that is going to manage your cancer, lengthen your life, improve your quality of life, and allow you to live happily ever after. You want the medication to work.

There are more than 6,500 cancer clinical trials available at any one time. For more common cancers, there may literally be hundreds of studies underway at the same time. This is good news. When there are many studies, that means there are many new ideas on how we might improve treatment and find cures. But for you, it can make navigating this a jungle and getting usable information a formidable challenge. 

 Start close to home
A conversation with your own doctor is always the best place to start. Tell your doctor that you are interested in experimental therapies. Your doctor or hospital may, in fact, be offering some clinical trials or may be aware of nearby programs that offer clinical trials for patients with your needs and interests. Even if you end up doing most of the research on your own, your doctor will be a key source of support and information. At a minimum, your doctor will need to share information about you and your cancer with those conducting the clinical trial. You will certainly want the support of your doctor and medical team.

Know your disease state: stage, prior, and current treatments

Before you begin searching, you need to know several key pieces of information about your cancer and treatments you’ve had so far. The more you know, the more quickly you’ll be able to narrow your search to what you want and not waste valuable time. Ask questions.

Each clinical trial is carefully designed for specific groups of patients. For example, phase I studies of brand new drugs are typically looking for patients with advanced cancer that has spread (metastasized) and is not responsive to standard treatments. Since we don’t know very much about how successful these new drugs might turn out to be, proven standard treatments should be tried first. But if nothing else is available, and you don’t have a proven standard treatment to fall-back on, a phase I trial is a reasonable direction to go.

Many trials focus on treatments for advanced cancers, but there are also trials for patients with earlier stage cancer. For example, trials of adjuvant treatment are testing cancer treatment that is administered shortly after the primary surgery or radiation in the hope of reducing the risk of disease relapse or recurrence. Some patients may be cancer-free after initial treatment but their particular cancer had characteristics that suggest a high risk of relapse. They may be interested in and eligible for such studies. Patients who are candidates for standard therapy (at any point in the course of the disease) may want to try clinical trials that are examining new approaches that hope to improve on the standard treatment outcomes.

Clinical trials are available for patients at all stages of cancer and with a broad range of prior treatments but the studies for one stage or situation will probably not be the same as those for another. Knowing your stage and treatment history is absolutely necessary before you can sift through all the possible trials to identify those of relevance and interest to you.

Next? See Part 2 in a few weeks
 




To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Sep 24, 2014

OHSU led Prostate Cancer Clinical Trial results in FDA approval

This is a reprint of an article from the  Portland Oregonian, written by Nick Budnick

A prostate cancer drug spearheaded by Oregon researchers has received federal approval based on studies showing it prolongs life without chemotherapy.

Enzalutimide was approved for prostate cancer under the name Xtandi® two years ago, but was authorized only for patients who were already on chemotherapy.

Now, the Food and Drug Administration has approved the drug for a new group of patients based on trials overseen by Knight Cancer Institute at Oregon Health & Science University.
The drug slows the disease, it doesn't cure it. However, the pill's expanded approval is significant for prostate cancer sufferers, many of whom never enter chemotherapy. Some don't care to undergo chemo's debilitating side effects, and some older patients are too vulnerable to even try.

The study found that the average treatment time on the daily pill – meaning until chemotherapy was deemed medically appropriate -- was 16 months, said Tomasz Beer, the institute's deputy director who oversaw the trials. Subsequent data suggests the period may be as long as 19 months.

In contrast, the average time before chemotherapy was required for people on the placebo pill was about four months.

"It's buying you close to a year and a half where your cancer is controlled by a pill," Beer said.

The drug also lowered the likelihood of death by 30 percent at any one time, according to trial results. The study was conducted on more than 1,700 patients in numerous countries including the United States, Canada, Europe, Australia, Russia, and Japan.

Treatment costs are about $7,500 a month.

Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker