About our project
The problem we solve: Of all demographic groups in the United States of America, Hispanics have markedly become a key target for improved clinical trial participation due to various significant reasons. According to the Society for Clinical Research Sites (SCRS), Hispanics currently represent 16% of the total U.S. population, however only 1% of clinical trials participants. Furthermore, it is estimated that by 2050, 29% of the U.S. population will be Hispanic, becoming an emergent majority. Nonetheless, when approached about participating in clinical trials, Hispanics commonly encounter social, cultural, and language barriers that hamper their involvement. Taking into account that the results of any clinical trial are directly dependent on, and provenly applicable to, the patient sample used, the degree of Hispanic participation in clinical trials brings into question the stated efficacy of any new products marketed to this population group.
About our solution:
Based on this problem of Hispanic nonparticipation in clinical trials, a group of young, upcoming Puerto Rican physicians have organized to increase both Hispanic patient and physician involvement in clinical trials through In Situ Global Clinical Trials Network, LLC, a cooperative of United States Board-Certified specialist and subspecialist physicians from more than ten (10) clinical areas, supported by a central Executive Core, and organized to conduct industry-sponsored clinical trials. Our mission is to improve the education and participation of Hispanic patients and physicians in clinical trials, all while collaborating on the development of pharmaceutical products, biomedical instruments, and clinical procedures. Our vision is to become the premier clinical trials support service provider for community-based physicians in Puerto Rico and the United States of America, with emphasis on the recruitment of Hispanic patients and physicians for clinical trials participation.
Progress to
date:In Situ Global Clinical Trials Network, LLC was founded in March 3rd, 2016, and since then has developed into a robust, comprehensive cooperative of twenty-four (24) United States Board-Certified Specialist and Subspecialist physicians on ten (10) clinical specialties prepared to address the specific challenges of Hispanic participation in clinical trials. Based in Puerto Rico, our physicians network englobes the Island, which encompasses a 3.5 million inhabitants population in a 3,500 square miles United States of America territory.
Now, our primary goal is to insert in the global industry-sponsored clinical trials pipeline, and our secondary goal is to integrate physicians on ten (10) more clinical specialties to further increase our clinical trials participation opportunities.
You are welcome to learn more about In Situ Global Clinical Trials Network, LLC at http://www.insitu.global.
About Our Team
Creator: Oscar Colon-Acosta
Location: Puerto Rico
Bio: I am a Doctor of Medicine with extensive experience and training in clinical trials, ranging from the Academia to the Private Industry. Recently I have become an advocate for clinical trials on a diversity of clinical areas, with special interest in the participation of Hispanic patients and physicians within the Puerto Rico and United States medical communities, through the founding and executive management of In Situ Global Clinical Trials Network, LLC.
Title: Founder/Chief Executive Officer
Advanced Degree(s): MD
About Our Company
How We Help Patients
Longstanding Hispanic clinical issues such as poor pharmacological response, polypharmacy, varied metabolism rates, and intricate genetic makeups inevitably force the question about the applicability of clinical results to this population group, specially in light of its low degree of participation in clinical trials. In Situ Global Clinical Trials Network, LLC strives to promote Hispanic patient participation in clinical trials by providing an engaging clinical, educational, and cultural platform, tethered to comprehensive logistics.
Hispanics patients interested in contributing to clinical trials through In Situ Global Clinical Trials Network, LLC will encounter a physician-based, patient-centered structure with a highly qualified and relatable Hispanic staff, dedicated to valuing and developing their participation in a fluent manner.
How We Help Physicians
The reality of the modern-day United States of America population demands the participation of both Hispanic patients and physicians. Therefore, In Situ Global Clinical Trials Network, LLC has been developed to support physicians on all administrative and logistics aspects of conducting industry-sponsored trials, thus allowing for their sole focus on clinical matters. Nevertheless, the relief of these bureaucratic affairs does not isolate physicians and clinical staff from corporate affairs, as all network decisions are open to the consideration of its entire membership prior to any action, allowing for a transparent and absolutely representative executive management. At In Situ Global Clinical Trials Network, LLC, Hispanic patients and physicians contribute to clinical trials, and help generate more effective biomedical products and processes, within a professional environment characterized by openness, collaborations, and efficiency.
Needless to say, Hispanic physicians participating in clinical trials are not only able to provide an additional clinical alternative for a segment of their patient population, but also become part of a unique professional experience. Collaborating in the development of a groundbreaking clinical product is a medical honor and a deep personal satisfaction.
How We Help Partners
In Situ Global Clinical Trials Network, LLC was created to address the dire need of both Hispanic patients and physicians in clinical trials, and their contrasting reasons for nonparticipation. While Hispanic patients question the motivations for their invitation to participate in clinical trials, Hispanic physicians often deem clinical trials an administratively and logistically bureaucratic activity that will ultimately affect any regular clinical practice.
Since its creation, In Situ Global Clinical Trials Network, LLC continuously searches for ways to advance its professional offerings, while incorporating resources that will facilitate the overall conduction of a clinical trial. Partners of In Situ Global Clinical Trials Network, LLC can expect the dedicated collaboration of a collective of experienced and highly regarded professionals that will strive to fulfill any clinical trials expectations. Detailed emphasis has been allotted, not only to the development of innovative operational structures and processes, but to the corporate alliances with other specialized organizations on matters that further ease the inclusion of Hispanics in clinical trials, such as linguistic and logistics services.
If your organization is interested in improving Hispanic participation in clinical trials, within a Hispanic environment, and with fully United States Board-Certified Hispanic specialist and subspecialist physicians, consider collaborating with us for a physician-based, patient-centered experience. You are welcome to learn more about our current and upcoming clinical trials affairs at http://www.insitu.global/clinical-affairs.html.
Innovation Details
Intellectual Property Summary
In Situ Global Clinical Trials Network, LLC, was solely founded and is executively managed by Dr. Oscar Colon-Acosta, MD, within an "Executive Core" comprised of three (3) other executives who, in direct collaboration with its current cooperative network of twenty-four (24) "Advisor" Physicians, develop and sustain all aspects of its clinical trials operations. Within these operations, there is an array of innovative business processes and trade secrets that are informally regarded as proprietary, and set it apart from other clinical trials initiatives in its area.
Clinical Information
In Situ Global Clinical Trials Network, LLC is strictly limited to the conduction of clinical trials, the clinical testing whose results are utilized to determine the clinical efficacy of biomedical products, as defined by the United States of America National Institutes of Health (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). In Situ Global Clinical Trials Network, LLC does not develop biomedical products itself, but collaborates with a wide array of sponsors to provide objective, unbiased clinical information, as per United States of America Food and Drug Administration (FDA) and Institutional Review Boards (IRB)-approved clinical trial protocols, to determine the efficacy of a biomedical product.
Regulatory Status
In Situ Global Clinical Trials Network, LLC was founded under the laws of the Commonwealth of Puerto Rico, a United States of America territory subject to exclusive and strict supervision of the United States Food and Drug Administration (FDA) for all clinical trials affairs. Clinical trials operations in Puerto Rico are monitored by the local FDA-San Juan District Office (http://www.fda.gov/AboutFDA/ContactFDA/ucm2005604.htm).
How we will use the funds raised
Clinical trials participation is not simple, and often requires significant time, effort, and economic investments by physicians. Community-based medical practices must invest in dedicated physical resources and services to meet the increasing expectations set forth by clinical trials sponsors, yet securing financial support for such endeavors is sensitive and complex, especially in Puerto Rico’s current economic situation. In Situ Global Clinical Trials Network, LLC, facilitates the clinical collaborations between patients and physicians in clinical trials by alleviating all administrative and logistics load related to their participation.
Any funds secured through Medstartr, Inc will be exclusively devoted to business development, including, but not limited to, the physical resources and services required for In Situ Global Clinical Trials Network, LLC to become a more comprehensive clinical trials solution for Hispanic patients and physicians. Once empowered with the resources necessary to fully address modern clinical trials requirements, the study budgets assigned by its sponsors will provide for the continued maintenance of these resources and services.
Thank You
“Unfortunately, there is no available treatment for your illness.”
This is the most dreaded news patients can ever receive from their physicians. Regardless of age, sex, or race, millions of patients worldwide are faced daily with the reality of currently incurable diseases and conditions, and their impact on quality of life and family. Fortunately, clinical research, and its constant development of new treatment alternatives, provides hope to all those in despair through the collaboration of patients and physicians in clinical trials.
Please witness this patient's firsthand account, courtesy of the Society for Clinical Research Sites:
https://youtu.be/Oya-in6gWIY
Help us advance medicine for millions of Hispanics waiting for an alternative to their clinical situation. A contribution today could help a loved one, or perhaps provide yourself an opportunity in the future.
