Are Decentralized Clinical Trials Effective?

The COVID-19 pandemic has been an expensive experience, costing months of delay to over 70% of all clinical trials.

In the world of clinical research, the pandemic has taught us more about what direct-to-patient trials really means, and how we can innovate to deliver better studies. Interviewing a mix of study sponsors, coordinators and investigators, it is clear that decentralized trials have been proven to deliver faster, easier and cost effective trials.

  • 61% say decentralized trials are faster than traditional trials in, saving clients under 3 months to recruit for a study

  • 75% say decentralized trials are better for patient retention

  • 79% say decentralized trials cost provide a lower overall cost than traditional trials

In a recent study that our team conducted, the client reaching out with the following concerns:

  • Traditional study design is taking over 6 months to recruit 150 patients.

  • Patients do not really need to visit a hospital, so why can’t we utilize a virtual investigator?

  • In prior trials, when patients visited the doctors office, 30% of the data was poor and patients had to do a secondary hospital visit (which should have been avoided).

Our team provided results using a mix of solutions and services that resulted in the following outcomes:

  • Recruited 150 patients in 3 months.

  • 100% of the patients were enrolled from the comfort of their home. The trained study nurses completed the study visit at the patient home.

  • 5% erroneous data – none of the patients had to do a secondary hospital visit or do any of the tests twice, as the nurses documented and uploaded source data to our platform, making it easier for the sponsor to qualify the data and clean the data.

If you are considering a decentralized trial, here are some lessons learned

  • Training is essential. If you are sending nurses to a patient home, ensure they have the proper clinical trial training (i.e. GCP, Protocol)

  • Not everyone is ready for the digital world (eConsent, eDiary, e…something), think of having a patient concierge service that can remotely support your patientsImportance of patient convenience dramatically improves clinical trials.

  • Re-think your protocol design and whether a patient truly needs to visit a doctor’s office.

Decentralized trials come in many flavors, using a mix of solutions to recruit a broader diverse population, randomize, electronically consent, and qualify patients, along with multiple ways of remotely engaging and collecting data directly from patients using mobile phones, and wearables, as well as the use of real-time notifications to engage the study team for possible safety issues or nudge the patient for upcoming tasks and visit confirmation.

Whatever your flavor is, let the experts at Delve Health help you streamline your current or upcoming study.

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