{"cache":{"posts_f30bc_11023":{"__typename":"RootQueryToPostConnection","nodes":[{"__typename":"Post","id":"cG9zdDoxNDc0MQ==","databaseId":14741,"featuredImage":null,"author":null,"date":"2012-08-03T06:00:39","uri":"/articles/incorporating-technology-and-dna-testing-into-clinical-trials","title_b28e9_bf21a":"Incorporating Technology and DNA Testing into Clinical Trials","slug":"incorporating-technology-and-dna-testing-into-clinical-trials","categories_3cd3e_bf21a":{"__typename":"PostToCategoryConnection","edges":[{"__typename":"PostToCategoryConnectionEdge","node":{"__typename":"Category","id":"dGVybToxMzQ0","name":"Research","slug":"23andme-research","uri":"/category/23andme-research","seo":{"__typename":"TaxonomySEO","title":"Research Archives - 23andMe Blog","opengraphTitle":"Research Archives","metaDesc":"23andMe research unique research model combines genetic and phenotypic information in what is among the largest databases of its kind.","opengraphDescription":"23andMe research unique research model combines genetic and phenotypic information in what is among the largest databases of its kind.","fullHead":"\n\n\n\n\n\n\n\n\n\n\t\n\t\n\t\n\n\n\n"}}}]},"imageOptions":{"__typename":"Post_Imageoptions","featuredImageSquare":{"__typename":"MediaItem","id":"cG9zdDoxMjU5MA==","mediaDetails":{"__typename":"MediaDetails","sizes_cad4b_bf21a":[{"__typename":"MediaSize","name":"thumbnail"},{"__typename":"MediaSize","name":"medium"},{"__typename":"MediaSize","name":"medium_large"},{"__typename":"MediaSize","name":"square_sm"},{"__typename":"MediaSize","name":"square_md"},{"__typename":"MediaSize","name":"square_lg"},{"__typename":"MediaSize","name":"wide_sm"},{"__typename":"MediaSize","name":"wide_md"},{"__typename":"MediaSize","name":"wide_lg"}],"height":298,"width":826},"mediaItemUrl":"https://blog-api.23andme.com/wp-content/uploads/2012/03/InVite-Logo.png","sourceUrl_772ce_bf21a":"https://blog-api.23andme.com/wp-content/uploads/2012/03/InVite-Logo.png"},"singleTemplateFeaturedImage":"default"},"content_b28e9_bf21a":"

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Many expensive clinical trials fail because the therapy causes harmful side effects in some or all participants or the drug isn’t effective across the board. Genetics may explain differences in response, but as of today DNA testing isn’t a standard part of clinical trials.

Integrating genetic testing into clinical trials should make it easier to determine why certain people benefit from a drug while others don’t. As the price of genetic testing drops, adding a simple test into an otherwise expensive and long process may also make the trial more efficient. Throw the Internet and other new technologies into the mix and speed and efficiency is further maximized.

The scenario goes something like this. A potential participant finds out about a trial through his or her doctor or online – anyone interested could receive alerts when a suitable trial opens. It’s been said that the biggest barrier to study completion is the shortage of people who take part and technology should be able to change this. Eligibility is confirmed by going to the trial website and answering a few simple questions.

About Clinical Trials

The goal of a clinical trial is to determine if a drug or other health intervention is efficacious and/or causes harmful side effects. Trials help ensure that only safe therapeutics are brought to market. Unfortunately this doesn’t always turn out to be the case since a number of drugs still end up being taken off the market after gaining FDA approval. For pharmaceutical companies, clinical trials are both expensive and time consuming. They cost anywhere between 100 and 800 million and take roughly five to nine years to complete once a drug enters Phase I testing in human subjects. The big kicker is that only one in five drugs end up with the stamp of approval – the rest fail at a high price tag.

The drug is administered to the patient through a physician, but instead of it being up to the physician to ensure compliance and gather outcomes, technology follows up. Participants receive text messages or email reminders to take the medication and are also asked how they’re feeling to see if the drug is affecting their quality of life. In addition to gathering data about survival, anti-cancer response and adverse events, it’s becoming increasingly important to find out if a therapy impacts quality of life.

Genetic data is collected easily with a saliva-based test – it’s mailed directly to the participant’s home, he or she spits, and then the test is popped back in the mail. When it comes time to analyze the results of the trial, the genetic information is layered upon other data points that are already routinely collected such as age, other diseases the person has, and life expectancy. Scientists look for possible associations between side effects and genetic factors while controlling for a myriad of other factors.

23andMe is already incorporating these ideas – utilizing technology and carrying out DNA testing – into drug studies. Our InVite study with Genentech is aimed at understanding how genes influence response to treatment for metastatic breast cancer. Participants find out about InVite through advocacy groups, social media sites, or their physician and enroll in the study online. They receive a saliva-based test in the mail and fill out online surveys about their experience taking bevacizumab, also known as Avastin ®. This drug is currently not approved by the FDA for treatment of metastatic breast cancer. 23andMe is actively recruiting participants and hopes to determine if a person’s genes could play a role in response to bevacizumab. Participants are not expected to directly benefit from this study.

(Women who began taking bevacizumab on or before December 31, 2011 are eligible for this study – see below for details.)

The example in this post represents a glimpse into the future of clinical trials, but also highlights the challenges ahead – therapies need to be targeted to the right people, technologies need to be tailored for data collection and genetic testing needs to be incorporated up front. With these changes trials should yield faster answers and won’t require as many participants. But the final goal is to arrive in a world of tailored therapy – where therapies are targeted based on the characteristics of both the disease and the individual patient to maximize the chances for success.

Research on the Genetics of Response to Treatment for Breast Cancer
\n23andMe and Genentech launched the InVite Study to understand how genes influence response to treatment for metastatic breast cancer. Visit https://www.23andme.com/invite-study/ or email invite-study@23andme.com for more information.

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Potential findings of this study may help to determine if a person’s genes could play a role in how they respond to Avastin .

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Editors note June 2013: Suzan “Suzie” Mickey lost her battle with cancer earlier this month. An advocate for better treatments for women with metastatic breast cancer, Suzie inspired many with her attitude. Our condolences go out to her family.

Positive, helpful, and upbeat. These aren’t words you would expect to describe someone about to start another round of chemo treatment. However, in the case of Suzan Mickey, they are very apt. Mickey is a participant in the 23andMe and Genentech InVite study on bevacizumab (also known as Avastin ®) and metastatic breast cancer. (Avastin ® is not approved by the FDA for treatment of breast cancer.)

A forty-five-year-old wife and mother of two pre-teen kids, Mickey has many interests, including an unusual predilection for antiques. Finding beauty in a broken and neglected piece of furniture, she says, is a metaphor for finding hope within a devastating diagnosis. Where many people would just see the peeling paint on an old cupboard, Mickey sees opportunity; where many people would see only the bleakness of cancer, Mickey sees blessings.

“I have to live my remaining days with cancer, and I am choosing to see the blessings that come with it as opposed to being focused on the challenges,” she said. “Although my diagnosis is not something I would wish for anyone, it has brought with it many incredible gifts. The love and support I have received from family and friends is humbling. I now focus my time engaged with those that I love, and I never hesitate to experience something new. The little things really do not matter…spending time with those that you love absolutely does.”

$\"\"$ If you have taken bevacizumab as a breast cancer treatment in the past, you may be eligible to participate in the InVite Study.

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Furthermore, all 23andMe customers can participate in other scientific research through 23andMe’s research surveys. Not yet a customer? Visit our store or learn more.

Given Mickey’s ability to see opportunity in even the hardest situations, it isn’t surprising that she is helping cancer research. Despite having stage 4 breast cancer, Mickey is cheerful and wants to help other women fighting breast cancer. Mickey joined the InVite study because she was interested in helping researchers learn more about bevacizumab and if genetics played a role in how patients responded to treatment.

Although genetics may be one contributing factor to treatment response, Mickey and her doctors believe that the healthy diet she adopted may have also played an important role in her response. After researching the impact of nutrition on chemo treatment response, she switched to a diet with no animal proteins, no dairy, no gluten, and no refined sugar, and instead ate lots of whole grains, legumes, fruits and veggies that are high in fiber. Mickey even studied at the Institute of Integrative Nutrition in order to become a holistic health coach, hoping to share this important nutrition information with other women facing chemo. Being diagnosed with cancer, she said, feels like the world is spinning out of control. Mickey believes that the foods she ate allowed her to stay strong and produce less estrogen, creating an optimal environment within her body which she feels gave the medicines their best chance at success. Thus, regardless of one’s genetic makeup, she sees a healthy diet as one positive way to take control.

In addition to encouraging good nutrition, Mickey says that she encourages other women diagnosed with breast cancer not to fear. And certainly, with her cheerfulness, enthusiasm, and concern for others, Suzan Mickey is living proof that a life with breast cancer can instead be a life of strength and hope.

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Earlier this year 23andMe and Genentech launched an online study of metastatic breast cancer to learn more about how genes might play a role in how a person responds to bevacizumab, also known as Avastin ®. (Avastin ® is not approved by the FDA for treatment of metastatic breast cancer.)

Since women began to sign up to participate in the study, we’ve expanded eligibility to offer more women the opportunity to participate.

We’ll be posting a few stories from patients and advocates about the study in the coming days.

We’re hoping to recruit 1,000 women living in the United States who’ve been diagnosed with metastatic breast cancer and who started treatment with bevacizumab before Jan. 1, 2012.

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This study does face some challenges, but we’re being helped by our partners that include the Avon Foundation for Women, BreastCancer.Org, Living Beyond Breast Cancer, the Metastatic Breast Cancer Network, the Triple Negative Breast Cancer Foundation, the Cancer Support Community and Facing Our Risk for Cancer Empowered (FORCE). Together we believe we can recruit women interested in joining this study.

If you have metastatic breast cancer, please consider joining this innovative study. If you know someone with metastatic breast cancer, refer her to the link so she can find out more.

23andMe’s research model holds promise because we can recruit people to participate in a study much faster than traditional methods. Our model can also eliminate some of the traditional obstacles that block people from participating in clinical trials. By combining participants’ genetic data with survey responses, we hope to discover new genetic markers for diseases, and understand why some people respond to treatment more readily than others. This information also helps our researchers explore how a person’s health is influenced by the interactions between genetics and the environment. (While this study may generate important scientific findings, participants should not expect to personally benefit from it, as the findings will not change how they are or have been treated for their disease.)

23andMe has already seen encouraging results in other ongoing research projects. We’re hopeful that this opportunity to work with Genentech in this first-of-its-kind clinical trial will yield promising results.

For more information about the InVite study email invite-study@23andme.com.

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InVite

Incorporating Technology and DNA Testing into Clinical Trials

An Active Participant in Breast Cancer Research and in Life

Participating in Metastatic Breast Cancer Research

Stay in the know.