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Financial implications of off-site visits in clinical research, perception versus reality

The concept of patient centricity is still relatively new within clinical trials. For too long, the most important person in the trial has been overlooked… the patient. Here, we explore the benefits of conducting a more patient-centric trial for the patient, site and sponsor through mobile, or ‘off-site’ visits. These advantages are much greater than purely financial, although the financial implications of running a more patient-focused clinical trial may previously have deterred some from this approach. Home nursing in clinical trials continues to be thought of as a high value “premium” service, which many sponsors decline in an attempt to remain within budget for the trial. However, is the actual cost of off-site nursing more expensive than the traditional site model?
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Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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