Regulatory Focus™ > News Articles > Lung Cancer Focus of Upcoming Patient-Focused Drug Development Meeting

Lung Cancer Focus of Upcoming Patient-Focused Drug Development Meeting

Posted 21 May 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has announced its third meeting on patient-focused drug development, this time focusing on the views of patients with lung cancer and seeking to identify unmet needs in its first patient population with cancer.

Background

Under the Food and Drug Administration Safety and Innovation Act of 2012, FDA was charged with setting up a "Patient-Focused Drug Development Initiative," which is set to seek out opinions from patients in 20 different disease areas over the next five years.

"The human drug and biologic review process could benefit from a more systematic and expansive approach to obtaining input from patients who experience a particular disease or condition," FDA explained in a Federal Register posting announcing the program in September 2012.

Practically, the program means FDA will start to assess the benefit:risk paradigms that each patient group is willing to accept in return for a treatment. A patient group suffering from an under-treated but otherwise medically benign condition might be less willing to accept high levels of risk in return for an effective treatment. Conversely, those suffering from a disease with few or even no recognized treatment options might be more willing than most to accept a drug that might either be less effective or more dangerous that FDA's benefit:risk paradigm ordinarily would permit.

The point, however, is for FDA to determine this framework in tandem with patients. The agency recently launched a new Patient Network website aimed in part at educating patients about FDA's regulatory process so that they can better engage with regulators at these meetings and at other venues.

Common Questions

FDA's lung cancer meeting is the third one announced thus far. The first meeting held was on chronic fatigue syndrome, a disease for which there is no approved treatment. The second meeting, announced on 20 May 2013, will be for patients with human immunodeficiency virus (HIV), a disease for which there are many treatments but no cure.

As with CFS and HIV, the questions FDA is asking of lung cancer patients have some parallels relative to one another.

Patient Perspective on Current Approaches to Treatment

Lung Cancer

HIV

CFS

Of all the symptoms that you experience because of your lung cancer, which 1 to 3 symptoms have the most significant impact on your daily life?

Of all the symptoms that you experience because of your condition or because of your therapy or treatment, provide one to three symptoms that have the most significant impact on your life?

What are the most significant symptoms that you experience resulting from your condition? What are the most negative impacts on your daily life that result from your condition and its symptoms?

Are you currently undergoing any cancer treatments to help reduce or control the spread of your lung cancer? How well do these treatments manage these symptoms?

What are you currently doing to help manage your HIV and any symptoms you experience because of your condition or other therapies?

What treatments are you currently using to help treat your condition or its symptoms?

How do these downsides affect your daily life?


What changes have you had to make in your life because of your condition? How does the condition affect your daily life on the best days and worst days?

What supportive care treatments, if any, are you taking to help improve or manage the symptoms you experience because of your lung cancer?

What specific symptoms do your therapies or treatments address?

What specific symptoms do your treatments address?


How long have you been on treatment and how has your treatment regimen changed over time?

How has your treatment regimen changed over time and why?

How well do these treatments manage these symptoms?

How well does your current treatment regimen treat any significant symptoms of your condition?

How well does your current treatment regimen treat the most significant symptoms of your disease?

Are there specific activities that are important to you but that you cannot do at all, or as fully as you would like, because of lung cancer?

Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition?

Have these treatments improved your daily life (for example, improving your ability to do specific activities)?

How well do these treatments manage these symptoms?

How well have these treatments worked for you as your condition has changed over time?

How well have these treatments worked for you as your condition has changed over time?

What do you consider to be the most significant downsides of these treatments?

What are the most significant downsides to your current therapies or treatments, and how do they affect your daily life?

What are the most significant downsides of these treatments (for example, specific side effects)?

Are there symptoms that your current treatment regimen does not address at all, or does not treat as well as you would like?

Are there symptoms that your current regimen does not address at all, or does not treat as well as you would like?


Assuming there is currently no complete cure for your condition, what specific things would you look for in an ideal therapy or treatment to manage your condition?


When thinking about your overall goals for treatment, how do you weigh the importance of prolonging your life versus improving the symptoms you experience because of your lung cancer?



How well do these treatments manage these symptoms?



What factors do you take into account when making decisions about using treatments to help reduce or control the spread of your lung cancer?



What information on the potential benefits of these treatments factors most into your decision?



How do you weigh the potential benefits of these treatments versus the common side effects of the treatments?



How do you weigh potential benefits of these treatments versus the less common but serious risks associated with the treatments?




Not present in FDA's questions were a second batch asked only of HIV patients regarding their desire to participate in clinical trials.

Patients' Perspectives on HIV Cure Research

What do you believe are the benefits of participating in an HIV cure research study?

What would motivate you to participate or to not participate in an HIV cure research study?

What risks would you find unacceptable for participating in an HIV cure research study, and why?

In certain HIV cure research studies, you would be asked to stop any other HIV medications that you are currently taking. How would this affect your decision whether to participate in an HIV cure research study?

The process of informed consent is an important way for the researchers to communicate the purpose of an HIV research study, as well as its expected benefits and potential risks, so that people can make an informed decision whether to participate in the study.

How should the informed consent clearly communicate to you the purpose of an HIV cure research study, particularly when a study is designed only to provide scientific information that could guide future research and development of treatments?

How should the informed consent clearly communicate to you the potential benefits of an HIV cure research study? In particular, how should the informed consent describe benefit when we do not think that participants in the study may gain any direct health benefits? 

How should informed consent communicate clearly to you the potential risks of participating in an HIV cure research study? In particular, how should the informed consent describe a study if there is very limited understanding about how the medications or interventions may affect participants or what are the potential risks of those interventions or medications?

Is there any other information that you would find helpful when deciding whether to enter an HIV cure research study?

What else do you want FDA to know about HIV Cure Research from your perspective?


The meeting will be held on 28 June 2013 at FDA's Silver Spring, MD campus.


Tags: patients

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