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title

Meet NORA (Network Oriented Research Assistant)

short description

Using a patient-centric telemedicine-based clinical trial approach, we will increase enrollment by bringing trials to patients at home.

Barriers

Our model alleviates the enrollment barriers surrounding patient access, awareness, geography and associated travel constraints, and trust.

Most patients do not live in close proximity to a research site. Patients that live near a site may not feel well enough to travel to the site or may be concerned about taking time out of their day. Patient awareness and mistrust of the medical community and the research field itself may also prevent patients from enrolling (see source links).

Science 37 believes that if you restructure research to make it more responsive to the needs and concerns of patients, more patients will participate.

Provide link to a source describing the barrier

http://www.ncbi.nlm.nih.gov/pubmed/21150469

Provide link to a source describing the barrier

http://www.ncbi.nlm.nih.gov/pubmed/23897588

Provide link to a source describing the barrier

http://www.ncbi.nlm.nih.gov/pubmed/21460590

What is your proposed solution to addressing the barriers?

Science 37's Proposed Solution.pdf

What are potential obstacles to your solution? How will you work around these roadblocks?

One potential obstacle is that patients may not have access to proper technology (i.e. smartphone/tablet, internet access). Another is that the patient may feel a lack of connection to the physician-investigator.

Patients enrolled in clinical trials will be provided with the necessary technology to be used from the comfort of their home or in research settings. To prevent patients from feeling a lack of connection to the physician-investigator, patients will have real-time access through telephone and video calls in NORA to trial staff.

What % increase in accrual rates do you anticipate?

We anticipate that clinical trial accrual rates will at least double using the Science 37 approach. Through our robust digital recruitment and patient-centric strategies, we will target appropriate patient audiences regardless of location, increase awareness, and ensure clinical trial integrity, all while maintaining patient trust and safety. Accrual rates will be proven upon completion of a successful clinical trial. Our management system allows for better data quality, facilitating subsequent analysis of clinical trial enrollment and trial outcomes. The participation rate will increase immediately, but we believe it will take 6-12 months to prove our enrollment goals for any given trial.

How do you anticipate maintaining the % increase in accrual rates over time?

As more clinical trials are successfully completed utilizing our strategies, we hope the research community will learn of our approach and partner with Science 37 for future clinical trial work. More clinical trials completed via patient-centric will yield increased accrual rates over time. Also as awareness of the model increases, and media attention increases more patients will know they can search online for decentralized clinical trials. This will provide a positive feedback loop for recruitment.

How will you overcome legal/regulatory hurdles, if any?

Science 37 works closely with study sponsors, the FDA, Institutional Review Boards, healthcare lawyers and digital recruitment experts to assure that we are in compliance with all applicable federal and state regulations. That said, innovation is occasionally met with resistance. Our successful launch of a Phase III trial this month suggests we can be successful moving forward with cancer trials as well.

Why hasn’t your proposed solution been tried before? If it has, what prevented it from succeeding?

The technologies that allow for NTCs have only recently become accessible to a broad sector of the population. Our proposed approach is in current use for non-cancer related clinical trials. We are currently witnessing great successes in clinical trial recruitment. The creation of Science 37 -- an innovative and somewhat disruptive platform and service-based company -- required an incredibly complex set of skill sets and core competencies including expertise in clinical trials, telemedicine, digital recruitment strategies, and mobile technology developers. The recent advances in several of these domains means that the timing is perfect to launch the Science 37 platform.

comments (public)

  • John Gregory Williams Aug. 3, 2015, 11:06 a.m. PDT
    Exciting developments!
  • Devender Kakar Aug. 3, 2015, 10:48 a.m. PDT
    Good work Noah keep it up .
  • Jeannette Draper Aug. 2, 2015, 3:24 p.m. PDT
    I work in a doctor's office ( of psychiatry) and am absolutely certain that this technology and process is needed to match patients/ clients and studies. I am supporting this for cancer in hopes that it could be duplicated for mental health and behavioral health trials.
  • Nathaniel Bautista July 30, 2015, 8:08 a.m. PDT
    Absolutely brilliant; a true testament to Noah and his team's ingenuity as they tackle a process that's become outdated and too slow paced in the modern day.
  • Manuel Palafox July 29, 2015, 5:59 p.m. PDT
    Onward and upward!
  • Udhaya Kulandaivelu July 29, 2015, 5:50 p.m. PDT
    Access is everything. Great idea!
  • Rene Yambot July 27, 2015, 4:35 p.m. PDT
    Good Luck
  • Diana Glass July 27, 2015, 4:02 p.m. PDT
    What a Concept! Good idea Noah.
  • Scarlette Deleon July 26, 2015, 5:53 p.m. PDT
    Good luck!
  • cora de jesus July 26, 2015, 10:37 a.m. PDT
    good luck ! keep up the good work !