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.