The solution is delivered and managed by Orange with key components provided by Hybrid 4, a specialist in developing patient data collection software and integration with pharmaceutical databases. Each patient is provided with a mobile device to enter their clinical trial data electronically. The new solution replaces the current paper-based forms to enable the instant submission and analysis of data to dramatically shorten the length of a clinical trial, reduce the huge volume of paper research, and obtain more meaningful reliable data.
Professor David Davies, Dean of the Faculty of Science at the University of Bath, Vice Chairman of the CPS (Chemistry, Pharmacy and Standards) and an Alternate Member of the Committee of Safety of Medicines stated: "The process of ensuring the safety and efficacy of new drugs is extremely important, but incredibly inefficient, producing a huge burden on pharmaceutical R&D staff, physicians, and patients engaged in clinical trials. The hope is that the introduction of this solution on a large scale will help to reduce this burden, and will have an enormous benefit to the population at large, making better and safer treatments available to patients much sooner than previously possible."
Alastair Macleod, Customer Development Director, Orange UK, added: "As well as pharmaceutical companies benefiting from automated data capture, the patient at home also benefits from a more efficient method and can be offered additional monitoring tests. Within the pharmaceutical industry, expectations are that technology could reduce development time by 30 percent and the return on investment will also be highly significant. With so much at stake, it is essential that the pharmaceutical firms choose the right partners to help achieve these efficiencies."
The data capture solution for clinical trials is just one of many health related solutions being investigated and developed by Orange. Wirefree technology enables patients' vital signs to be remotely monitored by placing a Bluetooth sensor on a patient's chest. The data is sent via a mobile device back to a central server where it is monitored by a clinician to improve the level of interactivity between patient and clinician. The solution could also support interactive fitness regimes whilst exercising at home or outside.
The new Orange clinical trial solution will introduce significant benefits in the following areas:
- Reduce the time taken to launch a new clinical drug to market
Currently, launching a drug in the market place from initial research stages can take up to 15 years, with up to half this time spent in clinical testing, according to a 1998 report from Tufts Centre for the Study of Drug Development.
The improved transmission of data from patient to clinician means errors can be detected earlier, thereby reducing time spent analysing the data at the end of the trial. Ultimately, this will also reduce the number of trials put on hold or cancelled owing to inaccurate or infrequently entered data.
- Collect more meaningful and reliable data
Access to clinical trial data in real time through Orange Wirefree Clinical will provide clinical trial study directors with instant visibility to any anomalies with the data or its transmission. The aim is to reduce overall data handling by three to four months, leading to a substantial cost saving to pharmaceutical companies.
- Availability of additional patient monitoring
The introduction of technology into the home environment with Orange Wirefree Clinical enables pharmaceutical companies to incorporate additional patient tests into the trials. For example, in diabetes trials, it will be possible to attach a device to monitor glucose and blood level to the handheld device and submit results as part of the trial process. This not only improves the quality of the information gathered on the patient's health, but also provides more accurate indicators for the success of the trial.
- Provide a solution that has increased safety measures for both patient and clinicians
Patients will be able to input data in minutes as opposed to participating in a lengthy paper-based process. It is also anticipated that Orange Wirefree Clinical will lead to improved patient safety on the trial. Instant monitoring of results means potentially life-threatening side effects can be identified and investigated immediately without jeopardising the patient or the trial.
- An international solution
With a global network operating on 259 networks in 116 counties, the Orange network covers all of the operating countries of the main pharmaceutical companies.