Establishing a Clinical Trial Program Site at a Community-Based College or University Step-by-Step Guide

Objective & Goals

DSCS Sweat Equity & Investments, LLC dba “DSCS CRO” often engages in consulting partnerships with various educational institutions to conduct clinical trials utilizing a community based approach and allowing these institutions to successfully compete with tertiary-based institutions in the following ways:

• Compete for NIH and comparable clinical research grants and Federally-Funded trials

• Conduct privately funded Industry-Sponsored trials

• Collaborate with primary care and specialist physicians in the communities in which the institutions serve and create new opportunities and health outcomes for the communities at large

• Provide practical “real world” experiences in clinical research for the institutions’ graduates or current students in the existing clinical research programs the institutions may offer as a supplement or continuation of the current curriculum

• Develop the framework for the institutions’ Contract Research Organization (CRO) which will create further opportunities for its students, the clinical research industry, and the community at large while also serving the online and distance learning students that these institutions might serve

• Collaborate with hospitals, integrated care providers, and other organizations by providing clinical research opportunities which the institutions will conduct and/or oversee

• Improve health outcomes in the communities they serve, particularly by increasing minority participation in clinical research trials

• Establish the institutions as the premier educational providers for clinical research in their regions

Project Overview & DSCS Synergy

For a typical educational institute to further contribute to the health of its community and enhance its learning and research opportunities, establishing a clinical trial site would be the first step in building the infrastructure necessary to:

• fully support a community based clinical research model ranging from the investigative clinics, research hospitals, the contract research organization (CRO) managing the studies

• support and develop internally, the clinical research associates (CRAs) monitoring the adherence to Good Clinical Practice and trial protocols, the institutional review board (IRB) or ethics committee tasked with overseeing the rights and welfare of the study participants

• vertically integrate to the capability of sponsoring its own trials and providing deeper and wider opportunities for its existing infrastructure to capitalize upon

Opportunities exist even beyond building this self-sustainable and synergistic clinical research private/public ecosystem when one considers the multiple, highly profitable, vendors that provide products and services to research clinics, CROs, and Sponsors in the form of technologies such as electronic data capture systems, clinical trial management systems, electronic source and electronic regulatory platforms to services such as patient recruitment and central laboratory functions which the institute can later develop by utilizing its existing resources. DSCS CRO is the ideal organization tasked with laying the groundwork for such an ambitious initiative. This white paper will outline exactly how this could be implemented, how DSCS has helped other organizations at past and present, and how DSCS is becoming a fully functional, vertically integrated, clinical research ecosystem of its own.

While most clinical research sites or CROs typically either compete in the public or private sectors, most educational institutions can integrate a community-based model with their educational institution status. This will allow the institution to not only compete in both the public and private sectors, but also within multiple verticals such as sites, CRO, and sponsor categories.

Training: DSCS owns and operates both The CRA Academy as well as The Site Owner Academy which teaches students how to work in the research clinic setting as well as how to work on the research clinic, respectively. More detail and case studies to follow.

• Industry Partnerships: DSCS is the preferred vendor for numerous CROs and biotechnology sponsors and is often approached by these stakeholders to assist in finding appropriate Investigative Sites for these protocols. DSCS will, via these business relationships, collaborate with educational institutions to: improve minority participation in clinical trials in the institutions’ regions, by partnering with local private practice physicians, training them and their staff on conducting Phase 1–4 clinical trials, providing the support staff need to successfully carry on further trials, and potentially create opportunities for the institutes in the process. More details and case studies to follow. Some opportunities to consider:

• increasing clinical research awareness amongst possible study candidates in the regions of the institutions

• getting the local community physicians, hospitals, and integrated care centers interested in and partnering with institutions to create additional revenue streams for their organizations

• allowing institutions to lead the initiative for advancing medicine in the region with institutions serving as a Clinical Trial Site, CRO, and/or study Sponsor depending on the appropriate situation.

DSCS has built this same model which it currently utilizes as it builds its own market share in the industry. DSCS has demonstrated effectively vis a vis its online-only CRA Academy, that the fundamental and practical building blocks of clinical research can be taught to its students effectively and with sustainable results. This can also translate effectively towards the educational institutions as DSCS has observed this demand for real world understanding and industry experience from the students it serves. It would serve a higher learning institution to have industry opportunities for the programs it educates on. Finally, DSCS is renowned amongst its clients, students, and stakeholders as being adaptable, and willing to go the extra mile for the organizations and individuals they serve.

Aligned Mission and Goals

Our own mission and goals revolve around establishing a foundation of sites, vendors, human resources, partners, and building a network of collaborators across the country to support our ambitions to vertically and horizontally integrate our capabilities to provide a full spectrum range of services from the research site level all the way up to the study sponsor segment. Having this mission as our guiding principle has allowed us to prioritize the value we seek to add to every business relationship we engage in as more important than the revenues or profits we can generate from them. Following this ethos has allowed us, interestingly enough, to grow at a much faster pace than our competitors in the marketplace, and gain greater market share year after year in the clinical research industry.

Detailed Specifications and Scope of Work

Market Size and Potential

With the supply of clinical trials increasing year after year (see graph below), the demand for additional experienced research centers has created a rare opportunity for individuals or organizations with the proper resources and infrastructure available for the establishment of a successful clinical trial site. This demand is currently so large that CROs and Sponsors are looking to either formulate exclusive site partnerships, or acquire sites altogether in order to maintain influence over these sites and ensure that their studies will be prioritized when it comes to patient accrual and competent human resource allocation. Further compounding the challenges of completing trials on time and under budget, Sponsors and CROs are observing that the emergence of rare disease studies is forcing the industry to turn to novice Investigators to conduct these trials which only increases the length of time for study startup procedures at the site level, as well as the amount of protocol deviations that research naive investigators are more inclined to commit. This 2018 article from industry publishing leader Applied Clinical Trials explains the problem while also highlighting the opportunities for organizations such as your educational institution to develop their own integrated research arm within their macro healthcare structures. Link here : http://www.appliedclinicaltrialsonline.com/need-and-opportunity-new-paradigm-clinical-trial-execution

And here is a clickable map link showing the number of registered trials in the United States.

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Another trend which many educational institutions can capitalize from is the lack of qualified clinical research professionals, ranging from study coordinators, to clinical research associates and trial Investigators, available in the marketplace. According to this article by an industry publication, the lack of experienced CRAs is actually contributing to the study delays plaguing the clinical research sector. https://www.clinicalleader.com/doc/are-delays-in-clinical-trials-due-to-a-lack-of-experienced-cras-0002

DSCS envisions these two key components of clinical research: a lack of qualified research sites, and a lack of trained professionals, as the major opportunities for most educational institutions to pursue. This report will also highlight several ancillary opportunities readily available utilizing a typical educational institution’s existing resources and infrastructure, but the aforementioned two critical areas pose both the greatest need and potential for revenue, and thus will be the primary focus of this report.

As of April 2019 in the United States there are roughly 150,000 clinical trials in startup or recruitment status on clinicaltrials.gov. Of these trials, most are industry funded trials while the remaining are funded federally in some capacity. This leaves the potential for most educational institutions to compete for the majority of these open studies this year if they can establish their own clinical research site(s) and framework for a larger network to compete appropriately. To do so, these institutions could collaborate with local physicians, hospitals, and integrative health facilities in the region either by establishing their own independent centers located in strategic areas in their regions, partnering with existing centers that are either conducting or not conducting research trials of their own, or a combination of the two. DSCS believes it is unlikely that established community based research trial sites would be open towards partnerships, unless the institutions can demonstrate that they can provide a business development pipeline of trial opportunities for these sites, as well as providing human and financial resources to these centers. Additionally, many of these experienced clinics and their respective physicians may also be eager to be the recipients of the institutions’ ability to submit to the NIH and other federal research grant providers and develop their own Investigator Initiated Trials in collaboration with these centers. Finally, having an educational institute’s brand association may also be a value add for some of these established clinics and research hospitals. DSCS is prepared and capable of assisting in building these capabilities of business development, grant and protocol writing, CRA and CRC training, as well as local physician recruitment services as it already performs these functions for its existing clients in this capacity.

Customers, Competitors, Collaborators

The potential customers for these institutes are plentiful. A further examination of the clinicaltrials.gov website link above will show dozens of various pharmaceutical, biotech, nutraceutical, and CROs looking for additional sites for their trials. If these educational institutions can demonstrate that they possess the capabilities for rapid study start up times as well as patient accruals from their study investigators, the institution brand could be a preferred site(s) for the majority of these trials. The NIH and other grant funders are also potential customers. In these cases, rapid study start-up and patient accrual rates are not as important as health related outcomes and community benefits of improving the healthcare at large would be. Alternating strategies should be utilized to pursue each of these two customers independently, and separate departments should be created to manage each business line independently.

The competitors also exist in most geographic regions in the United States, and another quick examination on clinicaltrials.gov would confirm as well as shed some further light on the particulars. The institutions, however, are uniquely positioned to compete for federally funded trials, as well as industry funded trials while also vertically and horizontally integrating their capabilities. This will potentially create unique opportunities and position them as unique stakeholders in their respective regions.

As for potential partners, DSCS has experience in partnering with, or working with both types of potential stakeholders. The research naive physicians or clinics require general awareness in regards to the fundamentals as well as business aspects of operating a clinical research site, while the experienced clinics require business development and human resource assistance. As a result, the business arrangements for each individual institute would be different in partnering with each various stakeholder in terms of the profits or revenues being split amongst the entities. DSCS has value added services we are prepared to dedicate in this regard with our negotiation expertise, as well as assessment of opportunities with partnerships. Furthermore, our Site Owner and CRA Academies can educate the potential partners on the various aspects required to operate a successful clinical research site. Each institute can also, of course, create its own independently owned and operated clinics and simply employ the Investigators and staff required to conduct clinical research trials. The costs for this would be higher depending on the size and objectives of the clinic, but would still have the potential of turning a profit within 6–12 months.

Partnership Possibility Models

Below is a typical cost structure for the minimum required expenses to operate a clinical research site with 3 scenarios, research naive partnership, experienced partnership, and an institute’s wholly owned site:

1.) Research Naive Partnership: 2 options: 1 is to defer payment to physician/group until institution receives payment from study Sponsor for trial activities. This would entail a larger percentage payment to the physician (50% of the gross receipts usually) however upfront costs (such as rent, utilities) would be deferred. Institutes would bring in their own study coordinators and operate as a site management organization under this scenario. The second option would be to share in the costs with the physician/group. These costs would include a percentage or the entire rent, supplies, utilities, etc. DSCS recommends institutes continue to bring in their own internally trained clinical research coordinators and operate as an SMO in these situations.

2.) Experienced Physician Partnership: Much like the previous example, the strategy of operating like an SMO and the option to defer or incur upfront expenses will still apply. As we are now dealing with experienced researchers, institutes could bring in an in house CRA or Project Manager from its Master’s Degree Program to serve as the Site Director, Project Manager, or Quality Control (Assurance) Specialist. Furthermore, the more experienced groups would want a larger percentage of the revenues/profits however, institutes could scale quicker using this partnership as less training would be required for the sites. Additionally, institutes can consider bringing their own sponsored trials to these centers if/when appropriate.

3.) Institutes wholly owned Sites: Having wholly owned sites that institutes either acquired or built from the ground up would also serve the institutes, particularly for providing graduates of the clinical research programs opportunities to hone their career skills prior to entering the workforce in the industry at large. A site can be an outpatient community oriented clinic, or even a small hospital that serves the local area population. DSCS specializes in helping organizations build their own research clinics from scratch, and would recommend the same for the institutes unless a financially suitable acquisition opportunity should arise. The model would be similar to medical schools that have their graduates conduct residency prior to being allowed to practice in the field. The institutes can be pioneers in establishing the standards and best practices for clinical research professionals and the institutes that educate them.

Strengths, Weaknesses, Opportunities

Most institutes possesses a plethora of strengths that can give them immediate advantages in the clinical research arena. As institutes should continue to establish research clinics in the communities in which they serves, provide and study alternative health options for its study participants, and create internship and work experiences for its students, institutes could successfully serve 3 of its core stakeholders: its students, the community which it serves, and the study sponsors or grant payers. By having a solid foundation of human resources available to service the clinics which it establishes, these institutes would arguably have one the best staffed and well-trained clinical research workforce in the private or public sectors in their regions. More-so, this synergistic situation would reinforce itself in a continuous cycle of obtaining trials, conducting the trials, educating the staff to conduct the trials, promote the study opportunities to the community, advance the institute’s scientific objectives, and utilizing the entire process to build each institute’s brand as the premier clinical research organization/Institution in the region, which would only continue to help accelerate this cycle.

One area in which most institutes would require strengthening would be in the business development realm of the private industry sponsored clinical trials segment of the market. Perhaps by combining DSCS’ core competency of educating physicians/hospitals/medical centers in the community of the business and financial benefits of conducting clinical research with a potential institute’s business or entrepreneurial program offerings, they could strengthen their private industry business development efforts. The institutes’ brand would be a strength, however most institutes are notorious for bureaucracy and slow start up timelines, none of which are particularly appealing to private industry businesses and entrepreneurs. By fostering a start up company ethos via DSCS’ industry business development model, most institutes can utilize their brand recognition to reassure the community entrepreneurs and physicians that their community focused clinical trial programs are nimble and efficient and perhaps even unhindered vial local Institutional Review Boards as most institutes’ research programs are under the jurisdiction of. DSCS’ legal team can assess under which situations various institutes would be allowed to be exempt from a local IRB and be able to utilize the industry-preferred services of a central IRB. The second area most institutes would require strengthening would be shortening their local IRB requirement timelines, or being exempt from utilizing it when possible.

One particular opportunity not already discussed in this whitepaper is the development of an institute’s internal physician Key Opinion Leaders (KOLs) that can serve to foster pharmaceutical industry relations with the institutes, obtain further NIH grants, and serve as professors in institutes’ teaching programsto attract further talent to the institutes. Additionally, KOLs can serve as unofficial “ambassadors” for the institutes and help to recruit other regional physicians to the institutes’ research programs.

DSCS has an industry partnership with Excella-Bio, a New York biotech and CRO, to deliver study opportunities for oncology, central nervous system disorders, and cardiovascular disease via novel investigational treatments with CBD and exosomes being two recent examples. By collaborating with an institute’s clinical trial program, DSCS and the institutes can further the development of treatments for the communities in which they choose to target, particularly amongst minority populations and the underserved, and will allow the alliance to reduce patient disparities and improve health outcomes to the uninsured via clinical research studies. The potential threats to this research initiative will be discussed further in this report.

Investment/Timeline/Infrastructure Needs

As most institutes already possesses the costliest and most difficult to obtain resources for most research sites, cros, and sponsors in the form of qualified human resources and scientific experimentation capabilities, the main focus should be on establishing business relationships with physicians, and other healthcare organizations in the community, as well as creating a synergistic business environment for its clinics and those the institutes choose to partner with. This would most likely require a small salesforce or “community outreach” team that prospects physicians with private practices in the community to engage in a clinical research partnership with as explained in a previous section of this whitepaper. This is one of DSCS’ core competencies, and DSCS would help the institutes establish its own best practices within the regions in which they operate. The initial salesforce team can initially be one or two full time employees as a test case for building a scalable model for physician recruitment and business development. The test period should be between 3–6 months and considered a success if each salesperson can successfully sign on at least 1 physician to join the institute in either one of the institutes’ wholly owned sites, or one of the two aforementioned experienced or research naive physician models from the section above. In the experiences of DSCS it typically takes 3–6 months to secure a physician to serve as Principal Investigator for a particular research clinic in most cities in the United States. The major expenses during this timeframe would be the hourly rate of the two sales personnel at roughly $23/hour. DSCS could train these sales personnel to follow the best practices which they have established which are summarized in this recent DSCS produced webinar

https://www.youtube.com/watch?v=JqG2t_oraLc&list=PLW2gHTCg_p82d8UJDuNxOJ3MnsBz8j7BU&index=8 .

Once an Investigator is secured, the research clinic would need to be set up to meet the minimum requirements to conduct outpatient clinical trials. From the experiences of DSCS, a site should be no smaller than 1600 square feet, with a temperature controlled secured and double locked room for investigational product, and some basic equipment. In our estimations and from previous experiences, the cost to furnish a site with equipment and a workspace for an otherwise vacant research clinic would be between 6000–12000 USD. Please refer to the image below as well as this video tour of a typical outpatient clinical research facility capable of conducting between 10–20 studies per year. https://www.youtube.com/watch?time_continue=322&v=sJ5tsJgxzk0 (webinar slides attached electronically to this report for reference).

Upon securing a physician to serve as Principal Investigator, the institute would ideally send an institute trained study coordinator to serve as the backbone for the initial studies that will be conducted in the clinic. This study coordinator would incur a cost of 23–30$/hr for a non-master’s level candidate, or 40–60$/hr for a master’s level or R.N. candidate. From the experiences of DSCS, one coordinator could successfully handle 3–4 studies at a time. DSCS and institutes will determine systems to assess employee workload as per the strategies and best practices of this webinar that DSCS produced recently https://www.youtube.com/watch?v=qmWxupbrFJs&list=PLW2gHTCg_p82d8UJDuNxOJ3MnsBz8j7BU&index=5 .

The infrastructure is rooted in a competent clinical sales force that would ideally and continuously need to prospect for new physicians to join the ever expanding institute SMO network, join institute’s wholly owned sites, or a combination of the aforementioned strategies. Furthermore, new study opportunities need to be procured on a regular basis. DSCS provides these services for its clients, and would provide this as a value added service as well. Once the initial site(s) is set up, institute would develop a robust infrastructure of CRAs and study coordinators to manage the studies and implement the protocols which the institute receives internally or from industry sponsored trials. This infrastructure would be self-reinforcing in terms of training new students online or in the physical class, interning the students, hiring the graduates when appropriate, and opening more sites within the region.

Potential Threats

PI oversight- According to most Sponsors in the Industry, Principal Investigators fail to maintain adequate oversight of the studies they are responsible for. https://eventscase.com/EN/FDA-inspection-training-program This is a potential risk/threat for any site that conducts clinical trials and will be no different for any institute. Should a lack of PI oversight at a site cause an FDA audit of some sort, the FDA will be inclined to audit other institute-affiliated sites. Furthermore, if lack of a particular PI’s oversight were to jeopardize the safety or well-being of a patient, institutes could potentially incur legal ramifications, negative publicity, and compromise future business endeavors in the industry. To prevent this threat from materializing, institutes should create appropriate Standard Operating Procedures, with the assistance of DSCS, and have qualified staff routinely conduct internal audits once per quarter for every institute-affiliated PI.

Community Sentiment Towards Research- Should a negative issue arise that catches the attention of the local community, institutes could experience issues related to the IRB (either central or local) that could make it difficult for them to be approved for future studies in that community. Much like the potential threat pertaining to PI oversight, institutes’ community outreach should proactively interact with community centers, support groups, or events where they can educate the public on clinical trials, increase awareness, and reduce patient and minority disparities.

Recruitment of Vulnerable Populations- Somewhat related to the community sentiment issue, there may exist the potential to inadvertently recruit vulnerable populations as opposed to the desired minority and underserved populations in many communities that the institutes seek to serve.

Virtual Trials- A particular technological disruptive trend in the industry that is gaining additional traction year after year is the concept of “virtual trials” or “site-less trials”. Under this new paradigm, Sponsors will recruit patients directly via online methods and conduct the study assessments remotely or in the comfort of the patients’ homes. Virtual trials are gaining prevalence in phase 4 trials and could eventually be applied to more complex phase 2 and 3 studies. This threat is also a potential opportunity for most institutes as institutes can utilize their CRO/Site Network status and combine them with the necessary technological systems readily available in their other departments, to compete successfully in this arena. As the market plays out over the next decade, most institutes would be able to make a better assessment of this threat/opportunity when appropriate.

Self-Sufficiency/Break Even Analysis- DSCS estimates that the typical institute program can become self sufficient within 1 year as is typically the case for most start up sites DSCS has consulted or partnered with over the years. Irrespective of the number of sites it chooses to open, each individual site would likely require 1 year to reach break even financial status even when accounting for hours invested by community outreach, study coordinator, administrative, business development, and investigator personnel. As mentioned previously, a typical site takes 3 months to identify and partner with a physician as a PI, another 3 months to procure the initial study for the PI, another 3 months for the site to become activated by the sponsor for screening purposes, and finally another 3 months to receive payments for the study activities. By analyzing profitability 1 site at a time, most institutes would have a better gauge on the projections set forth. This break even point applies to all start up sites irrespective of size.

Value Added Services

As has been mentioned above, DSCS is positioning itself to vertically integrate is core services and core competencies in hopes of reaching more potential students, clients and studies, and connecting more patients to appropriate trial opportunities. Below are some of the key value added services DSCS is prepared to dedicate towards this project.

• Training: DSCS prides itself on being one of the premiere and fastest growing, privately funded, for profit industry training providers in the industry. We have two core training programs which we will dissect in this section.

• The CRA Academy: Founded in 2015, The CRA Academy, www.TheCRAacademy.com prepares future clinical research associates or study coordinators to enter the research industry. What separates us from the competitors is the fact that we specialize in taking individuals with no industry experience, train them in our 3 month online program, and then allow them to gain industry experience by interning with us at one of our many research site locations nationwide. Another key differentiator, and a testament of our confidence in our program, is the fact that DSCS routinely hires its own students for various positions that become available either internally or at one of DSCS’ partner clinics. We have had a 60% placement rate for graduates of our program. The CRA Academy could be a supplemental training program and practical crash course for any institute’s potential staff of its Clinical Trial Program. Furthermore, we would allow students to visit our Sites in strategic locations throughout the country as well as Los Angeles for a 1 week practical internship.

• The Site Owner Academy: Founded in January of 2018, The Site Owner Academy has already helped dozens of physicians and entrepreneurs successfully set up their own research sites and reach profitability. The 3 month program, which students can complete more quickly if they choose to do so, has the option for networking via our private weekly webinars in which site owners discuss issues or opportunities that have been presented to their sites over the previous week. The Site Owner Academy could serve as a supplemental program for the institute’s Site Directors as well as physician partners in the communities in which the institutes would have a presence.

• Industry Partnerships: DSCS has been actively engaged in forming deep and meaningful industry partnerships since its inception in 2013. Research sites and other CROs routinely engage the services of DSCS in order to procure study opportunities, negotiate site/cro contracts and budgets, recruit physicians, as well as serve as on call consultants when clients need specific questions answered or issues/risks mitigated. DSCS is prepared to utilize this component of its infrastructure towards the benefit of the institute’s clinical trial initiatives.

• DSCS would relish the opportunity to help institutes construct a research model that is both scalable, and accessible for the communities it serves. Furthermore, via clinical research, DSCS will ensure that this initiative is also profitable and self sufficient. As a small business, we value the practicality of necessary profits that our industry can provide. By treating the model as a startup company, DSCS can implement the same systems it has helped hundreds of other small business achieve over the past several years. DSCS, particularly with its two core training programs, has been forced to adapt to the changing global economy and as a result, the entirety of our training programs outside of the internship (and sometimes including the internship portion itself) is online. The same can be said of our consulting services, as well as the majority of our CRO activities. DSCS understands the paradigm shift that the institutes are attempting to spearhead in education as well as in research and is prepared to be of assistance in any capacity institutes deems appropriate.

• Non Financial Support: DSCS CRO is our full-service contract research organization and business unit subsidiary. DSCS CRO often “white labels” its services to other CROs who seek to maintain their brand identity while utilizing our expertise, industry connections, and resources. DSCS is prepared to provide this service to most institutes if it is determined to benefit the initial stages of establishing this program. Digital marketing is another of our core competencies. By helping life science companies reach their desired target audiences online and in social and digital platforms, DSCS has create a content marketing strategy that could lend itself as a solid resource for many institutes in terms of raising awareness around their new initiatives to students, prospective students, and the industry at large.