Clinical Trials, 2017?

December 5, 2014
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

Clinical trials need to become a part of the treatment continuum, not separated from it as it is now.

 

Recently, on Twitter @Zymewire sent a Tweet my way: “@trialsonline - Think it's realistic of @23andMe to try and disrupt #clinicaltrials industry as AW hints here? ow.ly/EwKzM,” which links to a BloombergBusinessWeek interview with Anne Wojcicki, 23andMe Co-founder and CEO. It runs about six minutes, if you are inclined to watch, it’s interesting.

Wojcicki explains that she views 23andMe providing consumers control of the broken healthcare system by enabling them to be the center of change. She compared the change to what has happened to the media industry. Once consumers were empowered with information choice via the internet, the delivery of information had to change to fit their expectations, not the historical other way around.

Toward the end of the video, Wojcicki addresses clinical trials and research. Right now, she describes: “A [sponsor] will contact the PI, find human subjects and it’s a really slow, long process to run a clinical trial, a study. Let’s make research a real-time experience. We encourage millions of people to have their genetic information, filling out surveys, and engage them with researchers. The average 23andMe customer participates in over 230 genetic studies.” Wojcicki says it has the potential to significantly advance discoveries.

So to answer @Zymewire in 140 characters I said: “@Zymewire I think so. Clinical trials need to become a part of the treatment continuum, not separated from it as it is now. She makes sense.”

I’m editor that has covered clinical trials for a number of years, however, I’m not a CEO, or entrepreneur, analyst, or researcher. I see trends and curate information. But collecting insights from people including Jamie Heywood, Founder of Patients Like Me, and rare disease drug developers and many others, influence my view. And I harbor concern that the clinical trials industry is unsustainable in its current form.

Heywood says that people suffering with diseases don’t discriminate between treatments-approved or unapproved. I’m paraphrasing here: they see hope, potential, possibilities. This can be echoed by the recent public pleas for drugs in clinical trials to be given to those who see these treatments as their last hope. Even in the recent Ebola crisis, unapproved therapies were successfully used.

There is a whole clinical trials industry that revolves around making sure that patients understand their rights and role in a trial; that the data is collected in a way that is unbiased and with high quality; millions are spent to make sure that investments in research aren’t derailed by a regulatory unknown. What is true is that clinical trials are a part of healthcare, more so now than ever. Better treatments, treatments that qualitatively work better as informed by patient reported outcomes. But to speed up research and delivery, clinical trials need to be mainstreamed into the actual delivery of healthcare, not off to the side as a treatment of last resort. And for those reasons, I completely believe in Wojcicki’s statements.

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