Pfizer begins ‘virtual’ trial and calls for innovation in research

By Gareth Macdonald

- Last updated on GMT

Related tags Clinical trial

Pfizer has begun what it claims is the world’s first ‘virtual’ trial and says that such innovation is needed to make sure clinical research is sustainable.

The REMOTE​ trial, which is designed to assess Pfizer’s drug Detrol LA as a treatment for overactive bladder (OAB), uses mobile phone and web tech to record data from participants remotely rather than at clinics.

Data from the virtual study will be compared with those from two previous trials, A0221008​ and A0221046​, which used traditional clinic-based reporting protocols to see if the results can be replicated.

Pfizer spokesman Andrew Widger told that, if successful, the participatory patient-centred (PPC) model could offer considerable financial benefits.

One significant area will be a decrease in the cost of monitoring visits, which can represent as much as 50-75 per cent of a study budget.

Another significant cost factor for clinical trials is the set up cost for actual trial sites and the maintenance cost for sites that are recruiting no or very few patients. Again the single site concept may reduce these costs significantly​.”

Wider application

As yet the virtual protocol has only been approved by the US Food and Drug Administration (FDA) but, according to Widger, Pfizer has “started to develop a similar model to be implemented in Europe in the near future​.”

He went on to suggest that, in some trials, participants could take part entirely from home, while in other studies certain aspects of the PPC approach could be employed.

Modules from the PPC methodology may also be used in conventional “brick-and-mortar” trials – such as online consent, remote drug shipment, or use of mobile and telemedicine – to introduce incremental efficiencies to different studies​.”

Clinical trial change

Widger also believes the PPC model and the cost efficiencies it offers could be important to the future of drug research, suggesting that: “For clinical trials to be sustainable in the future there must be change​”

As the future of healthcare evolves, including further proliferation of electronic health records and consumers that are actively involved in managing their health information, the PPC model may continue to evolve, relying less on patients to self-report data and increasingly allowing patients to authorize and share their trusted health information.

“The model will also enable new roles for treating physicians to participate in research studies with their patients, with the responsibilities of the investigator centralized by this virtual approach.”

Related news

Show more

Related products

show more

How a Clinical MDR Helps with Data Quality

How a Clinical MDR Helps with Data Quality

Formedix | 16-Jan-2023 | Technical / White Paper

This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to...

Optimizing Adherence in DCTs

Optimizing Adherence in DCTs

PPD - Decentralized Clinical Trials | 12-Jan-2023 | Technical / White Paper

Prioritizing greater patient-centricity and creating an opportunity to reach unprecedented patient groups, decentralized and hybrid clinical trials are...

PPD is Supporting Complex EU DCTs

PPD is Supporting Complex EU DCTs

PPD - Decentralized Clinical Trials | 05-Jan-2023 | Technical / White Paper

PPD supports European DCTs and clinical trial sponsors with a holistic and comprehensive approach

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 14-Dec-2022 | 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