Optimizing Clinical Trials for Globalization

Implementing a series of best practices for clinical study and development conduct can simplify administrative processes for investigator and study teams, reducing overall costs in operating global clinical development.

For the past 10 years, the FDA has been making a concerted effort to modernize their clinical trials as part of its Critical Path Initiative. Their goal is to promote innovation related to the scientific processes used to develop, evaluate, and manufacture medical products. In particular, the European Medicines Agency is focused on ways to streamline clinical development. In one of last year’s drafts, titled "Reflection Paper on GCP Compliance in Relation to Trial Master Files (Paper and/or Electronic) for Management, Audit, and Inspection of Clinical Trials," the group proposed a switch-over to a fully electronic trial master file process.

CROs, regulatory authorities, and sponsors are all on board, yet the initiative is practically stagnant, due to limited resources and the high level of administrative involvement required.

The past decade has seen an increased globalization of clinical trials. Changes in regulatory timelines have sped up start times, and globalization has allowed for higher accessibility to study subjects, while reducing overhead costs.

Currently, studies are occupying several investigative sites, with fewer subjects per site—a change from the typical Phase II and Phase III studies which took place ten years ago. This not only effects sponsors and CROs, but also impacts new global investigative sites in a number of ways.

Paper Problem

Increasing the number of investigative sites per study results in an elevated amount of administrative paperwork. In a survey conducted by TransPerfect in October of 2011, which reviewed 121 global investigative sites, more than 75% confirmed they were using electronic data capture. However, 100% of the sites disclosed that regulatory binders and essential documents were still being handled as hard copies. According to the majority of these sites, they prefer to receive documents electronically, but sponsors and CROs require hard copies.

Multiple sites also means supporting multiple vendors. A survey presented at the DIA 2013 annual meeting revealed that a single site generally works with six to ten separate vendors during a study. Multiplying this across investigative sites per study results in a large number of vendors and contact points. Maintaining all of these vendor relationships, inevitably presents serious challenges.

Finally, the archival and retrieval process becomes increasingly burdensome with a multiple number of sites per study. Record retention regulations change from country to country. In order to comply with local requirements, most sites maintain storage of site files either within their own institution, or in an off-site storage facility. If an audit were to require certain files, several sites indicated it would be very challenging, if not impossible, to locate all necessary documents.

Going Paperless

In order to alleviate the burdens presented by an increase in the number of sites per study, stakeholders are encouraging the implementation of a few best practices to adapt to the changing landscape of the clinical trial process—primarily, implementing paperless regulatory binders and essential document processes. The global e-clinical solutions available today allow for a completely paperless process, from study start to finish.

Rather than spreading a study out over multiple sites, centralizing the process as much as possible can help to improve flow and organization. Using a single phone number, either globally or per local regions, can streamline processes and reduce confusion for all vendors involved.  Call flow and IVR routing support multiple languages, for all vendors involved, in a single call. The system can also triage calls to particular vendors involved in study support. As a result, site personnel are no longer required to call different numbers to reach different branches of the study.

With respect to streamlining the process, another best practice is creating and maintaining a single, centralized portal. Currently, most studies have several portals, with each vendor retaining their own.  Constructing one global portal with varying security levels will allow investigative sites and study teams to access all program information from one consolidated location.

Unfortunately, there is no quick fix to transforming clinical study processes. Current practices have been in place for almost two decades, and breaking the mold will require thinking outside of the box. Luckily, technology will have a major impact on revolutionizing the system. Taking advantage of the e-clinical services available, and implementing best practices globally, can alleviate administrative hardships for both investigator staff, and study teams. Applying these changes is a small step towards better access to study records, reduced costs, and a more efficient process overall.