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Perspectives

Clinical Trial Ops: Streamlining a Shared Burden

2016-02-19


With the Shared Investigator Platform, promising therapies can be brought to market more quickly.

With the Shared Investigator Platform, promising therapies can be brought to market more quickly.


Life sciences companies are under continual pressure to reduce clinical trial costs and the time it takes to bring new therapies to market. Unfortunately, they are often bogged down by challenges such as subject retention, medical adherence and the burden of managing huge volumes of administrative documents and tasks at investigative sites. Many clinical trial delays are caused by the need for investigators to use multiple clinical systems – each with its own user credentials and look-and-feel – and complete paperwork and other administrative and regulatory tasks for financial and trial management. In fact, administrative work represents approximately 30% of the activities required for any given study.

Many investigators also suffer from “trial fatigue,” as they feel out of touch with sponsors, burdened by redundant tasks and frustrated with incomplete data and slow information flows. All of these factors combined make it more difficult for biopharma companies to quickly bring effective treatments to patients.

Individual life sciences companies have tried to address clinical trial costs and efficiencies by creating information portals for their own investigators. Yet these individual efforts have had little impact for several reasons:

  • An individual portal does not reduce duplicate efforts among investigative sites related to clinical research and recording-keeping, which contribute to trial inefficiencies and costs.

  • Investigators still must log into multiple portals and systems.

  • Individual portals don’t effectively support today’s increasingly complex web of connections required to bring a proven therapy to market. 

Now a group of pharma companies is seeking to improve clinical trial efficiency through the development of the Shared Investigator Platform (SIP), with the vision of accelerating and simplifying the research and development of innovative new therapies. As conceived by TransCelerate BioPharma, Inc., a nonprofit industry group composed of the world’s leading biopharmaceutical companies, the SIP provides a common workspace for faster, more cost-effective clinical trial management by improving interactions between sponsors and investigators, such as more effective collaboration and streamlining of data and clinical trial information-sharing (Disclosure: We are working with Transcelerate  to develop the platform.) 

Shared Processes, Shared Platform

Developing a common platform requires understanding which processes can be simplified and streamlined across the industry to improve the experience of investigators. A shared platform should:

  • Strengthen the relationships between biopharma companies, investigators and regulators, both online and offline.

  • Support near real-time communication between investigators and sponsors.

  • Improve the investigative site experience.

  • Simplify and optimize clinical trials.

  • Streamline the access and integration of clinical trial data.

  • Create collaborative solutions across stakeholders focused on efficiency and value.

  • Increase data reliability, transparency and regulatory compliance.

  • Improve efficiency and scalability.

The SIP is designed to be shared among multiple sponsors. It will enhance organizational productivity by providing investigators and site staff with centralized access to clinical trial information, enhancing accuracy and reducing study startup time. It will also help pharmaceuticals organizations improve quality, regulatory compliance, process visibility and capacity while reducing investigator efforts related to training, document exchange and support.

Small Improvements Speed Therapies to Market 

The SIP roadmap initially focuses on simplifying clinical trial startup. In addition, it adds efficiencies to ease the administrative burden on clinical investigators and enable them to participate and collaborate in the clinical trial environment.

Interactive

Figure 1

Seemingly small efficiencies, such as secure single sign-on procedures, can result in breakthrough therapies and drugs being made available sooner, given that operational processes account for 45% to 75% of the time and cost of clinical trials. 

The Future Built on a Shared Vision

In the future, SIP features could include:

  • Drug supply ordering.

  • Mentoring, training and communications for aiding patient retention and providing investigator support based on social and mobile solutions.

  • Patient identification, screening and recruitment through database services and analytics.

  • Operational services, such as paperless financial, regulatory and performance reporting data, leveraging database services analytics and report templates.

The vision for SIP is to enable a true working partnership across all stakeholders aligned with a common goal, making it easier for the investigative site to conduct clinical trials. SIP fosters a community for support and mentoring, as well as the promotion of frequent and just-in-time communication for investigative sites and their staff. 

SIP will continue to evolve as technology advances to support the best, most efficient practices for streamlining clinical trials. The vision is for biopharma companies and investigative sites to reduce both time and cost on administrative tasks. At the same time, communication, collaboration and data accuracy should improve between sponsors and their sites. SIP is driven by a shared vision for optimizing clinical trials to help the industry meet the demand for delivering less expensive, more effective therapies in a timely manner.

To learn more about SIP and clinical trial challenges read our white paper, Making Life Easier for Investigators: A Shared Solution for Smarter, Faster Clinical Trials.

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Clinical Trial Ops: Streamlining a Shared Burden