Siteless CRO drafts guidelines for 'modern clinical trial'

By Melissa Fassbender contact

- Last updated on GMT

Center Point Clinical Services has announced new guidelines for clinical trials, including in-home and siteless clinical trials. (Image: iStock/thomas-bethge)
Center Point Clinical Services has announced new guidelines for clinical trials, including in-home and siteless clinical trials. (Image: iStock/thomas-bethge)

Related tags: Clinical trial, Clinical research

Center Point Clinical Services has released new guidelines that look to address clinical trial challenges by focusing on the patient, not the CRO.

As Outsourcing-Pharma.com reported​ in December 2016, the company launched what it calls “the world’s first siteless technology CRO​.”

The company’s services combine its Clinical Trial Research Pharmacist (CTRP) program with direct-to-patient medicine delivery and single-screen technology access for both the CTRP and patient.

Recently, the company provided an educational grant for a “key opinion leader” roundtable, which took place in December 2016, the company’s CEO Joe Martinez explained.

Stakeholders included those across the drug discovery process, including sponsors, clinical investigators, CROs, academicians, technology providers, and regulatory.

The guidelines were drafted after two days of presentations and discussion.

The key points are to engage the patient directly, to test drugs better and make them available to patients sooner and at less cost​,” Martinez told Outsourcing-Pharma.com.

This can be accomplished with the meaningful use of technology and by establishing a relationship with the patient by a trusted healthcare professional. In addition, the geographical restrictions of being close to a clinical site are overcome​.”

Martinez explained the guidelines address clinical trial challenges by focusing on the patient – instead of on the clinical research site or CRO.

In this way, more patients can be recruited faster, stay in trials longer, and provide more robust clinical data for regulatory review and potential drug approval​,” he said.

“The modern clinical trial is truly patient-centric and focused on delivering the necessary services and support to the patient in their home, providing both robust clinical and real-world data regarding the drug, device or medical procedure​.”

Best practices recommendations from the roundtable:

  • Enroll a more diverse trial participant population
  • Measure patient-centric clinical outcomes
  • Capitalize on existing digital sources of information
  • Encourage collaboration among public and private sectors to advance clinical trial research field

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