Tag: #PatientEngagement

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Design, Development, Business & Creative Help Wanted: NYU Healthcare Makerthon

Hi Everybody!

Recently, I was fortunate enough to be included in the 2016 NYU Healthcare Makerthon – an initiative between the NYU Entrepreneurial Institute & the NYU Langone School of Medicine. The goal of the Makerthon is to solve an important, health-related challenge by completing some step-work:

  • Identify the challenge,
  • recruit a quality team and then,
  • together, develop a solution into a viable venture.

My challenge is to “Re-imagine the medical research process to give participants a better experience.”

Does the number “$2.8 billion” sound familiar? If it does, you might work in clinical research. If it doesn’t, that number (and 10-15 years) is what it takes to get a therapy FDA-approved and to the public. PhRMA companies spent almost $60 billion on R&D in 2015. The NIH kicked-in an additional $31 billion.

Anyone who has ever looked at the numbers or attended a study Investigator’s Meeting knows, poor study enrollment and retention account for a huge portion of those costs.

Clinical trials account for nearly 40% of the US pharma research budget and total around $7B per year. The estimated cost of patient recruitment is 40% of the total budget, or $1.89B.

If a potential therapy is able to pass a recruitment feasibility assessment, the costs of enrollment often leads to study discontinuations and therapies that “die on the vine”. Additionally, sponsors may be forced to loosen study eligibility criteria to improve enrollment, only to hand the FDA under-powered data that is too weak to properly evaluate.

Before anyone clicks the back button because they (understandably) have a tough time feeling empathetic over Big Pharma’s recruitment woes, let me assure you I’m not trying to inspire empathy. There is more to the story.

Most of my research background has been limited to clinical trials with pharmacological interventions. But, more recently, I’ve been involved with other types of medical research at NYUMC’s Dept. of Radiology and Center for Biomedical Imaging. We have an amazing team of brilliant scientists, physicists, doctors & engineers (think Matt Damon in Good Will Hunting) – all working to improve patient outcomes through innovative imaging methods. The way I like to explain it to people who don’t regularly write mathematical formulas on window panes, is to try to remember what a television’s picture looked like in the 80’s and compare it with what you see today when you walk into Best Buy. There’s HD, 4K, curved screens, amazing sound, 3-D and VR. The quality of TV sets and peripherals has improved dramatically since Johnny Carson was on weeknights at 11:30 ET.

That’s essentially what our researchers are doing with medical imaging technology like MRI, PET, post-processing software, sequence development & 3-D printing. We move forward by recruiting study participants who graciously volunteer for imaging scan(s).

Some participants have a diagnosis such as Alzheimer’s, cancer, osteoarthritis or Parkinson’s. Others are healthy volunteers whose images are used for comparisons. From what i’ve observed, the participant’s experience is usually good enough for them to refer their friends and family to us.

I use imaging research as an example, hoping to soothe any lingering beliefs that medical research is confined to corporate interests. I admit, it’s easy to become jaded with all the negative press surrounding the pharmaceutical industry. But, to their credit, Hep C (associated with 19,659 deaths in 2014) is now curable in > 90% of patients (within < 12 weeks of treatment).

New pharmaceutical therapies have also contributed to a huge reduction in the amount of cancer, autoimmune and heart disease-related deaths over the last decade. But meanwhile, all over the world, researchers are developing technologies, medicines, prosthetics, implants, procedures, apps, software & naturalistic therapies (just to name a few) aimed at lengthening and improving the quality of human lives. Sure, it’s not all altruistic, but if people are earning a healthy living by developing these therapies, IMHO, it’s as it should be.

It seems to me that finding a solution to research recruitment/engagement challenge could cut R&D costs, resulting in lower healthcare costs and faster delivery of therapies to the patients who need them. But I digress.

After brainstorming potential solutions and getting some ideas on paper, I discovered the WordPress forums and managed to put some of my ideas into a website. I’m not a web guy and while building it, I wasn’t sure what may take shape. But I really enjoyed it as a creative outlet and it was therapeutic for me. TrialSphere also gave me an opportunity to shed some light on an idea that I had found tough to articulate.

Joining NYU Langone School of Medicine has exposed me to more opportunities than I can keep tabs on, including this Makerthon challenge. On 10/26/16, Makerthon participants gave brief overviews of their challenges to an audience of mostly NYU & NYU Langone Medical Center community members. After we said our piece, two Apple, Inc. engineers presented the capabilities of iOS, ResearchKit, CareKit and HealthKit. These open-source development platforms are powerful and the timing is perfect to build them into the research recruitment/engagement space. With the right team, we could leverage these platforms to build a simple, intuitive, powerful and scalable solution for this challenge.

My next step in the Makerthon project is recruiting a team of 3-5 people to join me. Ideally, I need a developer, designer and someone with general business skills. None of these skills are part of my background, but I can sure help navigating the research environment.

The Makerthon’s Phase II takes place November 18-20 (RSVP here.). This phase involves working with top healthcare investors, entrepreneurs and startup experts to help develop the idea into a viable venture. The top 4 teams selected by a panel of healthcare startup experts will receive cash prizes totaling $10,000 and advance to Phase III – “Venture Support” (Jan. 19-Feb. 19).

So, here is my call to YOU for action:

  • If you’re a developer, designer, business person, or,
  • if you have a desire to crack this challenge and believe you have something to contribute … please don’t hesitate to contact me directly or leave a comment below.

Enjoy the Cubs winning the World Series and Happy Halloween Everyone!

Many Thanks,

Steve Stork

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After the Clinical Trial: What’s Next for the Volunteers?

 

According to a 2013 CISCRP survey, 95% of clinical trial volunteers say they would consider participating in another study. The study reports that most people choose to complete a clinical trial for the following reasons:
• compensation
• to keep a commitment
• to gain knowledge of their disease
• positive response to treatment
• free procedures, study medication and study related medical care
• the relationship they built with the study staff
But what happens when the study is over? Where does the study volunteer go?

Many Investigators also operate a private practice, making it easy to continue a study volunteer’s treatment. For those investigators who do not have a private practice, it is important think about after-care. Many investigators are well-connected in the local medical community and are happy to reach out to other doctors and even set up a first appointment.

Patient Assistance Programs:

Clearly, many volunteers are attracted to clinical trials because participation is usually free and insurance is not required. Some studies will include a long-term, open-label extension, which means that the volunteer can continue to receive the study drug and maintain regular visits with the study staff for extended periods of time. But if this is not offered, Patient Assistance Programs (PAP’s) may be an option.

PAP’s are provided by most drug companies to help patients cover the cost of medicines. These programs are available for most brand name and generic medications. Each program has different eligibility criteria, but typically the applicant must not have private or public insurance coverage and have an annual income below a specified amount. People who qualify may be eligible to receive their medications at little to no cost. Investigators can usually help with the application process. Needymeds.org is a good place to start.

Plugging into the community:

Another tool is getting a clinical trial volunteer plugged into the community. There are national organizations such as The National Alliance on Mental Illness, The Alzheimers Association and The American Cancer Society, whose local chapters throughout the US provide in-person support groups and other valuable resources. Also, there are now social networks such as Patients Like Me, Inspire and other disease-specific communities where patients can share resources and support each other online.

Maintain Communication:

More is being revealed about study volunteers and their desire to be kept in the loop about a studies progress. Like any relationship, communication is key. Keeping volunteers updated on study results can let the volunteer know that they are part of something bigger and not just a “subject”. This type of communication could be in the form of a phone call, email or newsletter. If investigators could designate one staff person to update volunteers, it would really show the sites appreciation and keep the volunteer engaged.

Have you had any experience with these resources? Or, Do you know of any other resources that could ease the transition from clinical trial to traditional care? Tell us about it below!

 

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Is Apple’s “Research Kit” a Clinical Trial Game Changer?

Is Apple’s “Research Kit” a Clinical Trial Game Changer?

Apple’s March 09, 2015 Announcement did not disappoint, especially to us in the clinical research field. Today, Apple again managed to tell us what we want before we even know we want it, but researchers are asking:  Is Apple’s “Research Kit”  a Clinical Trial Game Changer?

Research Kit is a prime example. This open source software will allow researchers to collect valuable health data from over seven hundred million iOS users. Users may use E-consenting technology and share their health data with researchers, while keeping it private from Apple.

Apple’s formula for success so far has been in the products ability to give the control to the people. They provide the platform and the people provide the value. We can see this every day as new and useful apps hit the app store. There is no reason to believe that Apple’s focus on medical research will be any different.

While the Apple Watch is not yet mainstream, the same freedom given to app developers will be a major ingredient in the changing landscape of medical research and the development of innovative medications and treatments. As developers continue to see opportunities in the technology, new ways to monitor other health conditions are on the horizon. With the release of Research Kit, information can be shared in real time with researchers around the world. This is a major breakthrough.

While clinical trial recruitment has consistently remained an obstacle to medical innovation, we wonder how this new technology could be used to increase awareness of clinical trial opportunities, recruit participants and maintain an open dialogue between clinicians and volunteers. Study volunteers have consistently expressed a desire to be informed about the progress of clinical research and most wish to maintain the partnership with their researchers. TrialSphere’s goal has been to foster this interactivity and keep volunteers and researchers connected. With the news of Research Kit’s release, we wonder what your thoughts are on how we can use this to ramp up recruitment and retention rates in clinical trials.

Chime in below!