Imagine a clinical trial without large study binders crammed with paper copies of the protocol, the investigator’s brochure, patient consent forms, and the other documents necessary to perform a multicenter study from start-up to closeout. Instead of traditional paper-based methods, the sponsor and/or its CRO would create, distribute, and store key documents on an Internet platform hosted by a secure, private “cloud,” which is a massive, virtual network of servers outside the IT firewalls of both the pharmaceutical/biotech company that is sponsoring the trial, the CRO, and the clinical sites conducting the trial.
In clinical trial management (CTM) “utopia,” study personnel no longer would have to search their paper files and email inboxes for the latest version of a document, because the latest version would be the only one that they would see on the trial’s secure Web-based platform. “CTM utopia is that elusive world in which everything is electronic — from forms to signatures to submissions and approvals,” says Alison Shurell, VP life sciences product marketing at IntraLinks. “No paper, wet signatures, or overnight mail.”
This elusive world would have standardized documents and technology, says Lee Ferrell, a senior director of Quintiles, so that clinical sites’ personnel, many of whom are responsible for multiple trials, would not have to learn or retrain on a different format or technology for every new study. “The sites are excited about participating in a new trial,” she explains. “They’re just not excited about having to learn a new system.”
For Health Decisions President and CEO Michael Rosenberg, M.D., CTM utopia would be a seamless, integrated system consisting of modular functions that speak a common language to each other, both in collecting and broadcasting the information. With the broader acceptance and evolution of Clinical Data Interchange Standards Consortium standards, data will be more unified across systems, so it can be distributed through Web services to practically any platform. “The ideal system,” Rosenberg adds, “will be ubiquitous, flexible, and so tightly integrated into your role and study that you don’t realize you’re using a system at all.” And, access to the system would be 24/7, via smartphones, tablet computers, laptops, and desktops.
EDC Is Just The First Step
One of CTM’s utopian components — electronic data capture (EDC) — already is helping reduce the costs and time spent in conducting clinical trials. EDC has other advantages, too. It provides critical data in real time and is paving the way for the life sciences industry to go paperless. “The life sciences industry is heavily regulated and conservative in its adoption of new technology, so it has to proceed gingerly,” Shurell says. “Sites are desperate to get rid of the paper.”
Shurell’s company conducted a 2009 survey, cosponsored by Quintiles, which revealed that the number one frustration with clinical trials is the amount of paper required to participate in a study. The sites surveyed ranked delays due to slow and/or incomplete communications and redundant paperwork as the second and third frustrations, respectively. Rosenberg agrees, noting that the CRO industry is burdened with old-fashioned paper-driven data management systems that are inefficient and costly.
Today, sponsors and CROs can take advantage of a multitude of electronic tools, in addition to EDC, to make CTM more efficient overall. One example is an electronic solution that provides real-time trial information via customized dashboards on a cloud-hosted website and via electronic snapshots on the computer screens of trial personnel. Because such applications can be customized to each staff member’s role, the computer screen of the sponsor’s head of clinical programs might highlight budget and trial enrollment, while another configuration of the same application would alert the project manager about new queries from sites as well as enrollment updates.
Secure Transmissions And Huge Time Savings
By using Web-based cloud technologies, sponsors and CROs can securely transmit trial documents and other key study information to clinical sites, which can sometimes total 100 or more and be located throughout the world. Ferrell says secure electronic transmission of documents can significantly accelerate the study start-up process because sites have immediate online access to the protocol, investigator’s brochure, patient consent form, and other key materials. This eliminates waiting for the delivery of the study start-up package by a courier service.
“The clock is ticking,” notes Shurell, emphasizing the importance of reducing the time-to-market for a therapeutic compound under evaluation. Electronic transmission of trial documents also is a timesaver for the sponsor and CRO. “It just takes one click on the keyboard to send the start-up package to all 100 sites,” says Shurell.
The Benefits Of Cloud-Based Solutions
For CTM, a cloud-based solution offers many other advantages, including ease of use. For instance, to use the cloud, neither the sponsor nor CRO needs to be IT experts in this technology infrastructure. Since the cloud can be leased as “Software-as-a-Service” (SaaS), the IT departments of the sponsor and CRO don’t have to worry about maintenance and end user support. Using the cloud can also reduce the sponsor’s or CRO’s capital expenditures for IT, because the cloud owner is responsible for upgrades as new technologies emerge.
Another advantage of the cloud is its “elasticity.” The sponsor or CRO can scale up or down capacity and processing power, depending on the need. “Cloud computing can provide an extremely cost-effective hosting solution to scale a system for multiple studies or for large studies,” says Rosenberg.
When trial documents and other information are stored on a secure cloud-hosted website, the sponsor or CRO can track in real time each site’s progress by viewing and completing documents as well as by enrolling patients and reporting other information requested by the sponsor. In contrast, with a paper-based CTM, the sponsor or CRO often has to repeatedly telephone or email a study site to ask if they received documents and when they will complete the documents.
In addition, with a paper-based CTM, a site might return one document by email, another by fax, and still another by courier service, thereby requiring the sponsor or CRO to spend a lot of time, effort, and budget organizing and categorizing the information so specific materials can be quickly retrieved. The sponsor also must spend a significant amount of the clinical trial budget on paying Federal Express bills, Shurell points out.
Unlike paper-based methods, a cloud-hosted CTM can help ensure the rapid transmission and communication (i.e to all organizations/individuals requiring notification) of particularly crucial, time-sensitive documents, such as a serious adverse event (SAE) report. The communication not only can be automated but tracked. Safety teams can generate real-time compliance reports that provide a record of distribution, access, and delivery failure, because the times and dates the information was received and viewed by the recipients are electronically recorded.
The cloud is not without its critics, however. In August 2010, eWeek questioned whether cloud platforms can secure highly sensitive clinical trial data and health records. A private cloud can, its proponents say, because it can be set up to limit access to only approved users. By ensuring an audit trail through date stamps and other security safeguards, a cloud CTM can adhere to the FDA’s Computerized Systems Used in Clinical Investigations guidance.
The Importance Of Digital Signatures
Having the capability to digitally sign a legally binding document is another way an electronic solution can improve the clinical trial process. The software for digital signatures can be installed on a computer, cell phone, or other digital device, says Mollie Shields-Uehling, president & CEO of SAFE-BioPharma, a nonprofit consortium of biopharmaceutical and related companies.
SAFE-BioPharma’s technology is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents. She says digital signatures not only produce a permanent electronic record, “which is very important if the FDA conducts an audit,” but also eliminate the costs of storing paper-based documents that were faxed or sent by courier service. Other advantages are cost savings in personnel and faster transactions.
Envisioning True Integration
It’s not a utopian notion to integrate all major CTM functions on a single Web-based platform so all trial information, from EDC to advanced reporting on all key study performance metrics, is located in one place, Rosenberg explains. “It’s the bottom line to truly running trials as efficiently as possible,” he adds.
Sponsors and CROs can test cloud computing by moving only some of CTM tools onto this platform. Shurell says it’s not unusual for a pharmaceutical/biotech company or a CRO initially to use both paperless and paper-based methods on the same trial. Such a hybrid system helps increase the company’s comfort level with paperless methods.
If a sponsor or CRO decides to go totally electronic in CTM, the transition from paper-based methods will be gradual and must begin with a new trial, not a current study. Changing systems midstream could be very disruptive. “Companies will not want the new paperless system to be a variable that could affect the trial outcome,” says Shields-Uehling, who also predicts that in a few years the FDA will follow the EMA’s (European Medicines Agency) example and require that all INDs (investigational new drugs) and NDAs (new drug applications) be electronically submitted. The FDA now accepts applications in both electronic and paper formats.
Rosenberg says that electronic medical records (EMRs), in addition to EDC, are paving the way for the industry’s adoption of paperless solutions. “The recent emergence of EMR systems means many traditional sites are shifting to electronic collection of all information,” he says. “As the EMR environment matures and standardizes and as clinical data management systems begin integrating with EMR, we should see the industry finally drop its last paper-based processes.”
The time is right because never before has the pharmaceutical/biotech industry been under such intense pressure from stakeholders to trim drug development cost and time, adhere to government regulations, and introduce and market effective, safe, and profitable drugs that address unmet clinical needs.