Randomized clinical trials that assess the benefits and safety of a new drug or therapy are the gold standard in medical research. If well planned, they can offer assurances about a treatment that cannot be achieved in any other way. Currently, though, a clinical trial can cost up to $2.5 billion and take up to 10- 15 years to complete.
Add to these long durations and steep costs the traditional, siloed nature of clinical data capture/management applications and the new availability of huge (terabytes), of third-party real world evidence eSources for trial support, and you have an industry ripe for evolution.
To lower costs, shorten cycle times, and get life-saving medicines to patients sooner, the technology supporting clinical trials needs to be reimagined. Today, the power and efficiency of a cloud-based service environment offers the best hope to achieve faster, less expensive, more scalable trials.
The Best Hope
Have you ever heard the phrase, the whole is greater than the sum of its parts? That’s what the cloud can do for clinical trial processes; make them better by creating a fundamentally new way for them to work together, rather than siloed and stand-alone. The cloud can provide a unified, secure, and scalable environment offering real time, universal access to centrally stored data that only needs to be entered once, common tools to be shared across all processes, and enhanced collaboration among all stakeholders, leading to higher data quality and greater productivity.
Let’s take a closer look at how a cloud environment can help clinical trials of any size.
Traditionally, portfolio planning, building trial budgets and tracking resources, has taken months to research and set up. Researchers need to answer questions including: Do we have the resources to forecast reliable spending? Is our portfolio optimized for time and cost? Are we paying fair market value for our outsourced studies?
Using industry-specific algorithms for benchmarking/ball-parking, the cloud environment can quickly address these questions to create a unified and flexible clinical trial budget, track access to resources, and develop schedules for payments and regulatory submissions. Drawing on integrated, purpose-built, financial planning and sourcing tools for accurate projections, a cloud-based study build can add flexibility, efficiency, and transparency to study planning, forecasting, budgeting, and outsourcing needs. And, it can perform these tasks in days, instead of weeks.
Randomization and Trial Supply Management
Randomization enables researchers to remove selection bias from a trial. Historically, the process of finding eligible patients and assigning them to groups can take months to complete, sometimes even longer.
In a cloud environment, parameters for randomization processes can be set up quickly. Research into large electronic medical record (EMR) databases of potential patient candidates can be accessed and conducted in near real time. The cloud environment can offer self-service and on demand tools that can define and configure a randomization strategy, adjust trial limits, and set notifications. It can also apply++ the strategy at the study, site, or region level, as well as be assigned to specific events in a study.
Trial supply management ensures the right medical supplies are delivered to the right patients at the right time, while minimizing waste. Traditionally this has been a time-consuming process fraught with delays, missed details, and human error.
In the cloud, trial supply management can be easy, immediate, and self-service. Using guided tools, researchers can restrict who accesses supply files, who manages the drug inventory, and who is authorized to ship drugs to patients, making these functions more controlled and less a victim of “too many cooks”. Authorized study team members using centralized overviews can forecast the supplies needed for subjects at the various clinical sites, create orders to the supplying depots, update inventory systems on the receipt of consignments, and provide much greater accuracy, proficiency, and timeliness when dispensing kits to subjects during their site visits.
In past, when talking about clinical data capture, it meant collecting data from patients during trials and having clinical assistants enter the data into several different files. Initially done on paper by hand, data capture has evolved to electronic data collection. But this stand alone, siloed process is also full of redundancies, time delays, and errors.
Today, in addition to study data, there are now a multitude of other third party eSources (such as medical records, biomarkers, labs, and many more) available to researchers to strengthen trial results. The biggest challenges to including portions of these eSources are the time delays and issues related to loading and integrating the selected, structured and unstructured data into trial systems.
In a cloud environment, drawing on several capabilities to aggregate, organize, clean, manage, and analyze data, these issues evaporate, making it possible to create a single source of truth and deliver the right data to the right stakeholder in near real time.
Due to the isolated nature of traditional, siloed data systems within a trial, a lot can go wrong. Data sharing is difficult and the need for enterprise-wide responses to issues, such as information security and regulatory compliance often pose inefficient doubling or tripling of the work necessary by different stakeholders.
Cloud computing offers real time, transparent visibility into the trial data, making it possible for all stakeholders to share data, address security issues, and respond to regulatory needs through shared screens as they arise.
With the capability to organize, clean, and manage data from a single interface on a common platform, the cloud streamlines issues connected to lab management, data transformation, coding discrepancy management, data review, batch validation and more. It also allows researchers to check the performance of sites across regional/global geographies to data quality or trial risk issues and compare (anonymous) data across similar trials for results correlations and analyses.
Traditionally, these systems focused on maintaining and managing up-to-date trial performance and reporting. Milestones for tasks such as electronic trial master file (eTMF), site scoring, and vendor management were siloed and time consuming.
With a few clicks on an intuitive interface, the cloud can provide fast access to information from a wide variety of trial areas. Information from systems including eTMF, milestone documentation, source document reviews, site/trial monitoring, study training, and more can be shared and accessed by all stakeholders through a common set of functions.
Risk management, different for every trial, involves the monitoring of the people, processes, and technology associated with a given clinical trial. Tracking safety-related issues in a clinical trial involves many trial capabilities. It needs to be focused on key risk indicators (KRIs) and trigger management, subject level data reviews, study specific analytics, and targeted site support, all derived from the site level. Additionally at its core, risk management is also about tracking and pinpointing the risk factors of patient-related adverse events (AEs) and their causes as part of a larger regulatory record to meet compliance standards. Traditionally, risk management KRIs and AEs were kept in separate data silos, which made final reporting in a complete record time consuming inefficient, and often, not as accurate as needed.
Risk management in the cloud resolves many of these problems. The cloud environment is continually monitoring site data to identify risks based on statistical models. From a centralized monitoring screen adverse events can be addressed in near real time and protocol adjustments, per patient or per study, can be made at anytime from anywhere. In addition, due to its ability to draw on new, relevant data sources with ease, the cloud allows trial teams to stay aware of recent regulatory guidelines as they occur. Also, risk data visualizations and analytics from a current trial can also be shared with a larger enterprise repository for use in future trials.
Cloud Based Trials
Taken altogether, the cloud not only re-conceptualizes the trial as a service, but it also makes the trial better, by reinventing how the technology runs the entire study. And within this secure environment, it allows the researcher to focus only on the trial science, not the technology.
The global eClinical solutions market is expected to grow over 13% to $12 billion by 2025, reinforcing the industry’s confidence in cloud-based clinical trials. Supporting this vision, Oracle Health Sciences offers its Oracle Health Sciences Clinical One™ cloud-based eClinical environment, the only platform in the industry purpose-built from the ground up to support a trial from start to finish. Providing a series of capabilities, starting with Oracle Health Sciences Clinical One Randomization and Supplies Management Cloud Service, the platform unifies, accelerates and improves clinical trials, delivering better, safer, life-saving drugs to the market sooner.
Want to advance your trials? Let Oracle’s cloud-based Clinical One help. Contact us today.