Submission

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introduction
title
OWN IT! –Oncologists Welcome NewHaven Into Trials
short description
OWN IT! is a partnership between Yale and New Haven to increase cancer trial participation among minorities.
Eligibility
Barriers
The lack of minority participation in trials is seen in cities across the United States. Ethnic and racial minorities do not participate for a multitude of reasons including mistrust, fear of exploitation (owing to past abuses), and lack of awareness. But racial and ethnic minorities suffer disproportionately adverse outcomes from cancer. Overcoming barriers to minority clinical trial enrollment is a vital way to address this health disparity.

Source 1 (Cancer): This article discusses barriers to minority recruitment from the vantage point of stakeholders involved in the process—research staff, clinicians, leadership and referring physicians. The multidimensional nature of this problem suggests the necessity for solutions that are nuanced and inclusive. This study shows that health systems will need to evolve in order to achieve success but also suggests that transition brings substantive benefits for all involved.

Source 2 (NPR): This audioclip introduces an African American man with prostate cancer who enters a clinical trial. The listener can follow his journey from diagnosis to enrollment as he recounts reluctance to participate because of past transgressions by clinical investigators. The impact of hearing his voice adds context to the underrepresentation of ethnic minorities in clinical cancer research.

Source 3 (Annals Of Oncology): This is an editorial about the importance of cultural competence to health care systems and individual oncologists. The author argues that our diverse societies require bidirectional understanding to advance health equity and create trust. The discussion is directly relevant to cancer clinical trial participation as well as all aspects of effective cancer care.
Provide link to a source describing the barrier
http://onlinelibrary.wiley.com/doi/10.1002/cncr.28574/abstract
Provide link to a source describing the barrier
http://www.npr.org/2013/03/11/174016254/medical-trials-need-more-diversity
Provide link to a source describing the barrier
http://annonc.oxfordjournals.org/content/21/1/3.full
What is your proposed solution to addressing the barriers?
The_Ownit_Doc.docx
What are potential obstacles to your solution? How will you work around these roadblocks?
The potential obstacles of time and impatience are avoidable if we remember that partnerships develop at their own rate and cannot be forced. It is imperative that the cancer center representatives approach the program with patience and optimism. Minorities have seen clinical researchers come and go, along with their projects. The fleeting nature of research has led to mistrust. Continuity and sustainability is paramount to foster community engagement and demonstrate our integrity.
What % increase in accrual rates do you anticipate?
We expect to double minority accrual by the end of year 2. The target was selected because it is feasible given the large minority population in the city. This target is sufficiently robust to demonstrate the benefit of our intervention. We plan to use data collection infrastructure already built into the YCC program to collect ethnic and racial information of the trial participants.
How do you anticipate maintaining the % increase in accrual rates over time?
Clinical trials result in better care and more frequent evaluations. Once minority residents have the chance to choose trials, and have either participated or know those who did, the program will continue to grow and thrive. There are examples of community partnerships that have been published and have changed the perception of academic clinical research. The mission of OWN IT! is to reframe the image of cancer clinical trials to that of excellent care that may answer research questions as a bonus. With this change in perception, the trials will attract people and participation will continue to increase.
How will you overcome legal/regulatory hurdles, if any?
We do not anticipate any legal or regulatory hurdles. All clinical trials offered in our initiative are already approved by the HIC and compliant with regulatory practices.
Why hasn’t your proposed solution been tried before? If it has, what prevented it from succeeding?
One goal of YCC is to serve local minority residents, and leadership welcomes their input. Our solution is different and brings the cancer center out into the community at a familiar location that demonstrates equality, a cornerstone of OWN IT! As with any partnership, trust develops from commitment. Dr. Silber has worked with underserved patients for over 20 years, with a track record of working in minority neighborhoods. OWN IT is not another research project; our aim is to improve cancer outcomes for the poorest residents of New Haven.

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