Managing the life sciences clinical trial challenge

In the quest for safe and efficacious treatments, global life sciences organizations are required to conduct clinical trials.

These critical milestones on the path to regulatory approval and marketing authorizations have become potential roadblocks. The rigors of managing trials on a global basis, meeting regulatory compliance, and engaging stakeholders—all while maintaining speed to market—have created a challenge that can only be met with digital technology.

The Challenge of Patent Life Countdown

Clinical trial management is one of the most critical, time-consuming, and expensive aspects of the drug development process.

Starting with the discovery of a new substance in the R&D department the patent life countdown begins. Yet progress through discovery, pre-clinical, clinical trials, and review and approval can easily take up to 16 years, which means with a patent life of 20 years total, the new drug is protected for only four years.

This, in turn, can translate to higher drug prices for that medication since the innovators need to somehow recoup their investments.

The Goal is to Balance Speed and Quality

The faster your organization can get new trials initiated and completed, the faster you can get treatments into the hands of healthcare providers and patients. When a speedier process is achieved, so is an extended window for the commercial sale of the drug under patent, thus, increasing the return on investment from this process.

While speed is essential for the industry, it’s not the only concern.

Clinical trials require a balancing act: speed to delivery with the quality of data and processes to deliver the safest product.

Clinical trial operations and Clinical Trial Management (CTM) have become increasingly complex. Clinical trials usually take place in parallel in multiple clinics, across multiple locations around the world, with different teams handling each one. There are communication barriers that must be overcome, for clarity across trial locations and between clinical and data operations. Engaging all the stakeholders — including the patient — presents its own set of difficulties in the process, threatening both speed and quality parameters.

The Increasing Importance of Patient Engagement

Patient engagement has become a significant success factor for clinical trials, and there is an agreement in the need for technology to better support this aspect of trials.

A recent survey conducted by the AVOCA Quality Consortium found that there is not yet a common understanding of patient engagement for clinical trials and that much remains to be done to incorporate the patient voice and increase retention in trials.

Respondent results included:

As an industry, do we have a common definition of what patient engagement means when it comes to clinical trials?

  1. Not at all 21%
  2. To a slight extent 53%
  3. To some extent 23%
  4. To a great extent 3%

On a scale of 1 to 7, how successful have we [as an industry] been in incorporating the patient voice into clinical trials?

  1. Not at all successful 9%
  2. Minimally successful 34%
  3. Somewhat successful 42%
  4. Successful 10%
  5. Very successful 4%
  6. Highly successful 0%
  7. Completely successful 0%

“Even as patient engagement in clinical trials takes multiple shapes, the end goals are nearly always the same. Provide the patients with the needed information and motivation throughout the trial to encourage better retention and compliance—critical factors to the success of any clinical trial. Patient drop-out hovers at approximately 30-35 percent, but with new tools, patients have more options for engagement and more support for remaining in a trial.”

Achieving Best Practices in Clinical Trials

So how can digital technology support life sciences organizations to meet clinical trial challenges, while taking advantage of existing CTM systems that are already in use?

The ideal technology solution will enable:

  • A 360-degree view of the overall drug development process
  • Globally standardized processes, while allowing for local variations
  • Capabilities that support data sharing and provision of information for stakeholder (including patient) engagement
  • Easy preparation of dossier compilation and submission management for the review and approval process
  • The ability to answer audits from regulators, in near-time

What is needed is digital platform technology that provides an end-to-end view across the overall process. Technology that combines data collection from all stakeholders throughout the process, and connects relevant systems to create a 360-degree, real-time view on studies, substances/medications and the involved stakeholders; including patients, clinics, scientists, nurses, and regulatory affairs managers.

Delivering Results with a Digital Platform

Digital platforms have proven to be an approach that will help meet today’s clinical trial challenges. With Appian, The Digital Transformation Platform™ organizations have been able to:

  • Implement consistency across the clinical trials processes; including, Form-1572, Global CRO Contracts Management and Study Start-Up (SSU)
  • Leverage process automation to minimize manual activities, eliminate duplicate entries, and reduce risk of errors
  • Track the status of all required filings with the various governing bodies in different countries around the globe
  • Reduce SSU time from 6 months to 2 weeks
  • Cut the time for start-up documentation submission from 20 days to four days
  • Automate import of study information from across multiple sources
  • Automate SSU task management to eliminate gaps from manual work processes
  • Unify data for a complete and current view of SSU elements
  • Achieve a user-centric design (customer at the center of thinking)

As you consider a digital platform approach to address the challenge of clinical trials, keep in mind all these aspects, and that they can help deliver a single, unified view that shows which products were being tested where. This multitude of capabilities can advance your life sciences organizations along the journey to balance speed with quality.

The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.

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