Pfizer director defends virtual trial after recruitment struggle

By Nick Taylor

- Last updated on GMT

Related tags: Pfizer, Clinical trial, Informed consent

Pfizer director defends virtual trial after recruitment struggle
The head of Pfizer's virtual clinical trial has defended the project after its initial failure to recruit patients raised questions about its viability.

Approval of the trial, which allows patients to take part remotely, was hailed as a big step in the evolution of clinical research. However, since gaining approval the study has met problems.

It didn't recruit​”, Miguel Orri, senior director of clinical sciences at Pfizer, said at Partnerships in Clinical Trials in Orlando, Florida. After working towards approval for two years the setback was dispiriting for the Pfizer team.

Orri said problems stemmed from a failure, possibly caused by the team's regulatory focus, to appreciate what patients need. Aspects of the process were “quite complicated and tedious​”, Orri said, and Pfizer has learned that patients are still wary putting lots of their health information online.

In response to these realisations Pfizer has revamped the model. A call centre now helps patients through the initial steps and Pfizer is receiving feedback from participants to help shape its plans for the virtual trial model.

Since making the changes Pfizer has seen an “immense inflow of subjects​”, Orri said, but the delay means it is behind on its goal of recruiting 600 patients in the US. Despite the setback Pfizer is implementing plans to expand the trial into Europe.

The European trial, REMOTE 2.0, will learn from the mistakes of the US study. Pfizer wants to contract a recruitment vendor to help patients through the initial setup process to end the obstacles experienced in the US.

In a sign that Pfizer is considering the specific needs of the patient population, all participants in the European trial will receive a communication device. The device is like a simplified iPad and the idea is to help patients, particularly older woman from Southern Europe, who spend little time online.

“I don't think we've failed”

In the two years the Pfizer team spent working towards approval it faced internal skepticism, with Orri often being told the project was unfeasible. The struggle to recruit patients could give credence to these views but Orri was quick to defend the trial.

I don't think we've failed. We have created a new online informed consent process I think we can use in many studies in the future​”, Orri said. By taking a modular approach to the methods and tools used in REMOTE trial Pfizer can add effective virtual elements to its other clinical research projects.

The US Food and Drug Administration (FDA) encouraged this approach by telling Pfizer to validate all tools used in the trial, Orri said. After talking about the trial FDA officials told Pfizer to “milk the study​”, Orri said, and validate techniques for future use.

Related news

Show more

Related products

show more

The APAC Advantages

The APAC Advantages

Catalent Pharma Solutions | 18-Jan-2022 | Insight Guide

Over recent years, the Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies.

CellCarta - Mapping Precision Medicine

CellCarta - Mapping Precision Medicine

CellCarta | 17-Jan-2022 | Product Presentation

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

What to consider when working with CRFs

What to consider when working with CRFs

Formedix | 01-Nov-2021 | Technical / White Paper

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention...

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 26-Jul-2021 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Related suppliers

Follow us


View more