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.
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.
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:
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
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:
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:
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.
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.
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 firstname.lastname@example.org or +1 800 987 6007 ext. 2