- With Mayo Clinic nurse educator
Sheryl M. Ness, R.N.
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Sheryl M. Ness, R.N.
Sheryl M. Ness
Sheryl Ness, R.N., O.C.N., is a nurse educator for the Cancer Education Program at Mayo Clinic in Rochester, Minn. She helps inform patients, families and caregivers about services and resources to help them through the cancer journey.
She has a master's degree in nursing from Augsburg College. In addition, she is an assistant professor of oncology at the College of Medicine, Mayo Clinic, and is certified as a specialist in oncology nursing. Sheryl has worked for more than 20 years at Mayo Clinic as an educator. She has a keen interest in the importance of the quality of life and concerns of people living with cancer.
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Living with cancer blog
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March 16, 2013
How new cancer drugs are developed
By Sheryl M. Ness, R.N.
Have you ever wondered how new drugs are created and approved for the treatment of cancer?
Every year, researchers study and develop new treatments in hopes of finding just the right connection to stop or prevent the growth of cancer cells.
While it may seem that every day we hear about a new cancer treatment that's available, the tedious process can be 8-10 years in the making.
The agency regulating drug approval is the Food and Drug Administration (FDA) within the Department of Health and Human Services.
The FDA is in charge of making sure that new drugs, vaccines, gene therapies and other biological treatments are safe and effective before they are released on the market for standard treatment for cancer patients.
To make certain that new drugs are safe and effective, first the new drug is studied in the laboratory and with animals. Next, clinical trials with people are needed to study the safety and best dose of the new treatment. This is done in Phase I clinical trials.
After the first phase of study is complete, it moves on to Phase II to study how the new drug works against a specific cancer. Researchers continue to focus on safety and report the side effects, complications and short-term safety.
If the early phases of the research are promising, the drug continues on to Phase III which compares the new drug to standard treatment. This is typically done with hundreds of people across the country or around the world.
Finally, if the new drug proves to be better than the standard treatment, the FDA reviews all of the research data, including the risks and benefits and any new side effects, and makes a decision regarding approval.
During the process of approval, the FDA can decide if the new drug should have a priority classification — a faster approval, which means that the new treatment shows major benefits over existing treatment.
The FDA uses an independent advisory committee to review each new drug application. The committee is made up of experts in the field of medicine and research as well as consumers (patient advocates).
If you'd like to learn more about the approval process for new drugs, see the National Cancer Institute's website. For more information about cancer clinical trials, see Mayo Clinic's clinical trials website or the National Institute of Health's clinical trials website.
What are your thoughts on how new drugs are approved?
Follow me on Twitter @SherylNess1. Join the discussion at #livingwithcancer.
12 comments posted
April 15, 2013 7:06 a.m.
Phylis, a second opinion is a good idea any time you feel that more information is needed to make a good treatment decision. Or if you do not feel comfortable that all of your needs are being met. Many times, with a situation such as a rare or unusual cancer, a second opinion is important. Other times, if a patient has other chronic health conditions or complications it may be important to seek a second opinion. You might also ask if your Cancer Center is NCI-Designated as a Cancer Center.
- Sheryl Neess
April 2, 2013 6:57 a.m.
We are trying to figure out when it is important to get a second opinion. We have an appointment at Mayo, however, we find our Oncologist was a resident as well as a fellow at Mayo. Unnecessary to think treatment plan might be different? Thank you.
- Phylis
April 1, 2013 10:08 p.m.
this comment is for Dale --- every research study has different inclusion criteria and your mother's oncologist should be able to explain what trials they have at their institution (and even possibly neighboring institutions) that your mom may be eligible for. the oncologist would also be able to explain whether or not the study drugs have been tested in individuals of particular demographics, including age.
- leigh
April 1, 2013 10:03 p.m.
as an irb administrator living with cancer i'm very glad to see this post and would like to add the important role the institutional review board (irb) staff and members have in reviewing research before it can be conducted. it is the irb's duty to ensure that the research proposal meets the criteria for approval on many levels; while our work is administrative in nature we are an important cog in the research paradigm; advocating for the research participants first and foremost. all the best.
- leigh
March 27, 2013 9:42 a.m.
This post is for Audrey. Mayo Clinic would be a wonderful place to have your daughter evaluated for specialty care. We have cancer specialists and nutritionists that will work together to coordinate her plan of care. Since she is a cancer patient, you can call medical oncology (507-284-4137)to start the appointment process and they will get the process started for you. I hope this is helpful.
- Sheryl Ness
March 24, 2013 1:39 p.m.
I am a hairy-cell leukemia patient, who has been through chemo twice. I saw on TV today (3/24/13) that a doctor took T-cells from a leukemia patient, ssomehow altered them, and put them back into the patient, that caused a virus that only-destroyed cancer cells in a patient's body. They claimed this as a cure to leukemia, breast cancer and other cancer patients. Could you at Mayo write a story about this treatment? Thank you for your newsletters and all the info that is ccontained in them!
- John
March 22, 2013 10:51 a.m.
new drugs should not be tasted on animals.
- No name given
March 21, 2013 12:33 p.m.
I wish the process was a little quicker. I know they want to make sure the drug is safe, but it is frustrating for patients, knowing there is something they may be able to use so close, yet just out of reach. Personally, I am tired of throwing different chemo drugs at my ovarian cancer, that I have been fighting since 2006, and hoping something works. After three recurrences, my body is worn out from the cancer and effects of chemo and radiation. Targeted therapies are the future. I hope to be able to utilize them soon!
- Angel
March 19, 2013 12:10 p.m.
"While it may seem that every day we hear about a new cancer treatment that's available, the tedious process can be 8-10 years in the making." The FDA is given far too much power over the restriction of treatments. It is true that the treatments must be carefully assessed before they are endorsed by physicians, but I feel that the precautionary principle exercised by the FDA is extremely costly, restricts speedy innovation of new drugs, and doesn't allow patients to receive the care they need. Reading the other comments in this section is heart-wrenching... it makes me wish the FDA was more expedious in the manner in which they approve drugs. If only the Mayo would make a stand to say how corrupt the FDA is, and demand a speedier system for our patients!
- Emmett
March 18, 2013 10:26 p.m.
my dau has been diagnosed with Fibrolamellar Carcioma in 1999 --she has had 8 major surgery's and has had the major nerve to stomach nicked and lost 5/8 of her stomach. She is on a feeding tube . . . do you have any one at Mayo's who specializes in this type of cancer? Would you have a gastro and nutricial and cancer people who would review her condition? She has 'outlived' her original prognosis, could she be a candidate for additional treatment. Her only treatment to date is surgery. She has no cancer Dr. - and limited gastro Dr. and a lack of nutritional care . . needs hydration 3x week -- her quality of life is slipping due to needing the feeding tube and several IV's per week -- any idea's? I personally know of Mayo's excellance in helping me and my husband -- my dau. is sceptical . . .that anyone can be helpful to her .. she has not had the advantage to see a 'team' that specializes in her medical problems . . . can you advise. . . .please --
- Audrey
March 18, 2013 7:47 p.m.
do patients with ostomies have a higher risk of colon cancers or polyps?
- Kidbjp
March 18, 2013 7:15 p.m.
Are the clinical studies designed in such a way to include patients of all ages? My mother is 80yo with stage 4 colon cancer. How can I know if the cancer drugs she is being prescribed have been tested on the elderly (whose bodies metabolize drugs differently?)
- Dale
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