White Paper

Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers

Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers

By Colleen Hoke, Founder and Chief Executive Officer, Augeo; Scott Weidley, Chief Executive Officer, ClinCapture

With growing demands in clinical research, clinical studies can be a growth opportunity for hospitals, clinics, and academic centers. But clinical research is not an easy business and it takes thorough planning, adequate tools and expertise. You will need to familiarize yourself with business and partnership models, regulations, select and implement the right clinical data collection and management technologies to succeed.

According to ClinicalTrials.gov, the total number of US-based recruiting clinical studies reached 15,396 as of June 2016. The total number of studies registered on the website and based in the US reached 93,842 with California, New York, and Texas leading the way. Nothing seems to indicate that the growth of the number of clinical trials will slow down in the foreseeable future.

This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.

The different models that garner sponsor, physician, and patient interest

This applies to commercial sponsors, pharmaceutical companies or their partner Clinical Research Organization (CROs), as well as non-commercial sponsors.

  • Therapeutic Provider: Particularly in the areas of Oncology and Cardiovascular Medicine, patients demand new services and solutions and there is an extensive amount of emerging interventions coming to the market. In this case, the clinical acts like a therapeutic provider, unlocking new potential treatments for patients.
  • Early Phase Research Provider: Inpatient access is required for Phase I Clinical Research and associated overnight stays. A core of highly trained staff is needed with automated tools and extensive controls to help managed a voluminous amount of data points is fundamental to this research.
  • Primary Care Provider: The later Phase III or IV clinical trial research is essential to sponsors and is increasingly attractive to physician groups and hospital organizations. They may engage a site management organization or outside fractional staffing to assist in managing and running their research programs. By utilizing contracted research services, they can gain flexibility in scaling up or down quickly to meet requirements and efficiently conduct research.
  • General Inpatient Research Provider: Typically, a community hospital based providers that supports a wide variety of device and medical research. For example: Orthopedic trials, antibiotic research or IV nursing oversight research, and pulmonary or Emergency Department medicine.
  • Lab Tissue Bio Bank Provider: Acquisition of fluidic and tissue samples paired with relevant EHR data to support prospective clinical research trials.

Is your site suitable for clinical trials?

If the answer is no to any of the following questions, you will need to add capability to take on studies.

  1. Commitment. Do you have at least one committed dedicated resource to manage personnel, patients and ongoing transactions required to run a study? This person can be resourced either in house or outsourced to a skilled clinical trials coordinator (or ideally some combination as you grow to help mitigate the lumpy build-up which is common in early start-up research sites).
  2. Expertise and Leadership. Does the group have an internal scientific or medical expertise and a “Champion” that will be available to meet with other potential Principal Investigators, Sponsors and patients? Sponsors will look for expertise that best matches the pharmaceutical product or device they are developing.
  3. Regulations and Standards. Are you familiar with the Federal, state and institutional regulations and rules required to conduct research? Research is a highly structured and well documented industry. You will need to establish the operating procedures, processes and controls required to conduct studies at our site. There are standard operating policies available in the public domain that can be leveraged and adapted to suite your practice. An outside consultant can also assist in identifying the basic set of policies needed and adopt them to your specific area and research needs.
  4. Collaboration. Are you ready to collaborate with outside groups to establish a growing and successful research program at your site? You will work closely with an Institutional Review Board (IRB) in order to conduct research. The study sponsors will require process and reporting that that you will need to comply with. There are many other outside groups and service suppliers you may also need to work with:
    • Consultants to assist in setting up the processes and documentation needed
    • Systems providers to consistently capture key information with automated capabilities
  5. Technology. Do you have expertise in eClinical technology to capture and manage clinical data from patients? From Electronic Data Capture (EDC) to CTMS (Clinical Trial Management Systems), technology vendors have developed a number of solutions that sites use in conjunction with sponsors and CROs to collect patient data in a secure and efficient manner. The ability to capture data and manage it as a requirement to be ready to conduct research. If you don’t have knowledge or expertise in this area, you will need to learn or team up with a CRO that does. Of course, CROs and
    Sponsors favor sites with experience using these systems. It makes the implementation and the conduct of the study easier.

If you have these basic capabilities established, you can approach sponsors to identify research opportunities. The market for servicing the growth in research is also growing in terms of real growth as well as more outsourcing from Pharmaceutical companies on the range of services that surround clinical research conduct and management.

Key attributes a sponsor will consider in placing a study

Sponsors will select study sites based on key capabilities and attributes:

  1. Recruiting. Being able to recruit qualified participants and fill the trial in a timely manner is the primary selection criterion of sponsors when selecting a site. (This is discussed in detail in the following section.)
  2. Quality. The site needs to demonstrate they are compliant with General Clinical Practices (GCP) and have an excellent safety history.
  3. Therapeutic area capability and competence. Doctors and scientists who will be the Principal Investigator(s) must have demonstrated expertise and recognition in the relevant area or practice.
  4. Track Record. A history of running trials well and completing the work on time and within budget. Responsiveness and flexibility to handle changes and challenges in the course of the trial are also important considerations.
  5. Quality. The site needs to demonstrate they are compliant with General Clinical Practices (GCP) and have an excellent safety history.
  6. Therapeutic area capability and competence. Doctors and scientists who will be the Principal Investigator(s) must have demonstrated expertise and recognition in the relevant area or practice.
  7. Track Record. A history of running trials well and completing the work on time and within budget. Responsiveness and flexibility to handle changes and challenges in the course of the trial are

Select compliant and user-friendly data collection technologies

Clinical data collection can be a complex process, so familiarizing yourself with the right eClinical systems could save you time, money, and headaches. According to the Society for Clinical Research Sites, in 2012, 60% of study sites had 3 months or less of operating cash. One of your priority should thus be to invest in cost-efficient, yet compliant and feature-rich technologies to ease the data collection and clinical study process. This is usually something sponsors and CROs will select and manage but sites have a greater and greater role to play in selecting the right data collection and management technologies for the study. Knowing the best systems will give you a head start to successfully implement your first study.

Traditional clinical data collection processes are based on paper CFRs (Case Report Forms), even though EDC (Electronic Data Capture) systems have been slowly replacing them for the last 20 years. EDC systems collect clinical trial data electronically rather than on paper and are becoming the most popular solution for streamlining data processing. However, there is still a strong perception that paper-based studies are faster to implement than studies based on EDC (Electronic Data Capture) systems. While it is undoubtedly true that studies can be started quickly on paper, data shows that their overall duration is as much as 30% longer on average1.

Cost is also a strong factor in favor of EDC: In a Forrester Research Paper2 reported by IMB and analyzing EDC cost-savings compared to paper-based collection methods, data showed visit-related costs were reduced by 50%, data cleaning costs by 80%, and all other operational expenses by 32%.

Electronic Data Capture also ensures a significantly higher clinical data quality. According to Campbell Alliance in Realizing the Promise of EDC: A Practical Guide3, sponsors experienced a 5-fold decrease in manual queries when making the switch from paper to EDC.

One of the main concerns with selecting an EDC system is the training and potential steep learning curve for teams unfamiliar with this type of software at clinical sites. Select an EDC that is well supported and easy to handle for the users in charge of collecting data. ClinCapture is the only validated electronic data capture software available for free and a leading cloud-based eClinical software. It has been repeatedly chosen for ease-of-use and user empowerment. “Having access to a validated cloud-based EDC tool that requires no resource for infrastructure, maintenance and updates, allows us to focus on the business of drug development” reports Henk-André Kroon MD, MBA, Chief Clinical and Medical Affairs Consultant for Hallux Inc. “As an early stage company, we can choose the service package that is right for our business or stage of development and upgrade when needed.”

Compliance, clinical data standards and quality requirements

GCP Compliance

Understanding your regulatory environment is a key to build successful clinical research sites. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.

Good Clinical Practices (GCP) describes the obligations of the sponsor, monitors, investigators and Institutional Review Boards (IRB) in protecting human subjects, both in the laws governing clinical research and the ideals of research ethics and “good science”. GCP is widely accepted and expected in clinical research. It is an umbrella for laws, regulations, guidances, standards and requirements for Standard Operations Procedures (SOPs) around clinical trials.

21 CFR Part 11 Compliance

Promulgated by the FDA, regulations are codified in the collection of all current regulations, called the Code of Federal Regulations (CFR). In particular, in relation to technology, you will need to select eClinical systems that are compliant with 21 CFR Part 11 requirements. These requirements include that:

  • Any change to any record is captured in the audit trail and these entries are time stamped with additional information including operator name and why the record was changed.
  • System provides adequate security to prevent unauthorized modification by ensuring role-based access and preventing users from directly updating the database.
  • Software employs electronic signatures for any transaction into the system.

Clinical Data Standards

The CDISC clinical data standards have been in development for more than two decades. These standards support the electronic acquisition, exchange, and archival of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC defines several data models for the interoperability of clinical data exchange. They are standardizing the format in which data is being collected in order to accelerate and streamline the clinical data collection and management process.

For sponsors and CROs, standards are one the keys to save time and money in the path to drug development. “A couple of years ago, in December 2014, the FDA put out the requirement notice that clinical studies for drugs needed to be submitted in the CDISC format: The official deadline for this requirement is the summer of 2016” reports Carey Smoak, co-founder and co-leader of the CDISC Device team. “Sponsor companies now coordinate with the FDA ahead of time regarding their specific projects and requirements in order to be ready when they start their study, and ultimately when they get to the data submission phase […] We’re currently completing the requirement to having an established set of standards for medical devices”. As a clinical site, familiarizing yourself with these data standards can help ensure that you’re speaking the same language than CROs and sponsors when it comes to clinical data collection and management.

Third party companies to provide management, technology and regulatory expertise

The demand for research continues to increase globally year over year. The aging US population has driven growth in terms of the number of clinical research trials and aggregate budgets for research. The increasing affluence in Asia and India have also contributed to demand for research that is focused on these populations. These factors will continue to propel industry revenue in the next five years.1

A clinical research consulting service like Augeo can act as an operational partner to assist in establishing and running a successful research program. A variety of systems nationally have addressed gaps in the research services and knowledge continuum on behalf of their constituents by utilizing a shared service model. Together we can address the following build requirements for setting up research site (or extend a research brand within a healthcare delivery network provider) by:

  1. Lower operating costs by reducing the number of direct employees necessary per trial resulting in better flexibility and higher efficiency.
  2. Improving organizational learning and innovation by leveraging technical and managerial expertise with subject matter experts with proven tools and processes.
  3. Increasing research related development activities and service quality by establishing a formal and focused customer- oriented culture within the organization.
  4. Professionalizing service delivery to physicians, Sponsors and patients by bringing current and best practices to the research program.
  5. Enhanced credibility for the research program and assistance in resolving internal conflicts with ongoing clinical work demands.

Conclusion

Start by setting your goals and a model you would like to establish for your clinical site. For example, complex oncology phase III adaptive studies will require a very different expertise and setup than phase I academic studies. Setting up a clinical site is similar to setting up a new organization, you will not only need the paperwork and the tools, but also the ability to create and maintain a financial plan, establish communication and recruitment channels for patients, set up partnerships with the right organizations, and adopt technologies to deliver results on time and budget for your clinical trials. To ensure success and mitigate risk, work with proven systems and processes. Rely on experts and partners that have done it before and technologies that are both feature-rich and flexible to adapt to your growth and needs over time.

About Augeo

Augeo provides assistance to physician groups, hospitals, universities and laboratories in establishing, managing and promoting clinical research programs. Our focus is to advance research business goals by helping to establish a customized framework of process and technology for a cost effective, highly productive and compliant research program. Services range from providing fractional executive oversight and other key resources to technology selection and implementation. Augeo is located in the Nashville Tennessee area. Visit augeopeople.com for more information.

About ClinCapture

ClinCapture is the only validated electronic data capture software available to sponsors and CROs for free. As a leading cloudbased eClinical application, ClinCapture empowers its customers to build their own studies, lower their clinical trials costs, and streamline their data capture processes. Headquartered in San Francisco, ClinCapture offers solutions for single-site studies, multiple-site studies, and enterprise organizations. Start creating your study at clincapture.com. Contact us at contact@clincapture.com or +1 800 987 6007 ext. 2