ePRO Solutions: Should we eliminate paper altogether in clinical trials?

??????????????????????????????????????????According to a study by CenterWatch, if the market continues to adopt ePRO technologies, paper diaries will no longer exist in 10 years. In an increasingly interconnected world, where technology can make data available in real time and increase the quality of collected data, why are we still using paper diaries to collect subject data in clinical trials? 

ARITHMOS looks at potential scenarios in clinical trials using paper vs electronic diaries and provides an example of a respiratory study in which an ePRO solution determined the success or failure of the study outcome. 

 

Quality of Data: Collecting Accurate Data in Real Time

In a paper diary scenario, clinical trial leaders face many challenges including illegible forms and uncompleted questionnaires. This wastes a Data Manager’s time trying to decipher a subject’s diary entries and ask for missing information.  More importantly, paper doesn’t always guarantee an accurate and honest response. The British Medical Journal reports in a pain study example, 45 percent of subjects invented data because they waited until the deadline to fill out questionnaires and had to recall weeks of data.

ePRO takes the burden off the subject and allows clinical trial leaders to have more control over the situation. Devices can be programmed to send reminders to subjects so they fill out diaries with real time data and submit data in real time.

Compliance

Technology has allowed ePRO devices to come in all shapes and sizes – from smartphones to tablets that integrate with Glucometers to spirometric devices that capture respiratory data. These devices have been proven to increase compliance among adults and elderly subjects who can adjust viewing screens and respond to questionnaires with a simple click.

Moreover, studies have demonstrated that subjects have a greater sense of privacy with ePRO devices. Subjects might be hesitant to respond honestly on a paper form knowing that various people will read their answers. In a study on female sexual dysfunction, subjects reported 80 percent more sexual episodes on an eDiary as opposed to a paper diary (cit. CenterWatch).

Reducing Study Timelines, and Inevitably Costs

ePRO solutions can be significantly advantageous for biostatisticians, especially when applying an adaptive approach to a study. Based on accurate and high quality data and data available in real time, biostatisticians can adjust sample size calculations and study endpoints which can potentially save money.

Paper diaries may be a viable option when time is not an issue, however is a time when pharmaceutical and biotechnology companies are struggling to cut trial timelines and costs, this hardly seems a feasible option.

ePROARITHMOS can provide a customized ePRO solution for its customers or work with third party ePRO devices and integrate with the eCRF. Below is an example of an ePRO solution ARITHMOS implemented in a respiratory study which used a hybrid solution:

A CRO contracted ePRO and EDC services for a respiratory study combining eCRF with paper diaries and paper questionnaires. The device was a spirometer with an integrated QoL questionnaire. The study also required a short deadline with external providers for IVRS, laboratory data and ECG and direct upload of spirometry data onto eCRF. Milestones included:

  •  eCRF receiveddata from 2,000 subjects in 14 countries from 207 sites
  • It was easy to identify subjects who experienced problems in using the ePRO and perform the appropriate corrective actions
  • The team was able to have the last query resolved to database lock in 2 days using innovative technology solutions to integrate a spirometric device with EDC
  • Each subject was given a Spirometric device for 1 year, collecting 700 records each. Over 14,000 total records were collected with almost 100% success. Any mishaps were handled immediately due to an alert system.
  • Blind Review Meeting was done 2 days after study completion since all data was immediately available. Without the spirometric device, it would have taken up to 3 months.

ARITHMOS Appoints Software Developer for ArithmosCentrum

ARITHMOS Technology welcomes Gateano Giusto to its team as an experienced software developer to continue the development of the ArithmosCentrum ERP software package.

ARITHMOS announced today the appointment of Gaetano Giusto as Head Software Developer for ArithmosCentrum Enterprise Resource Planning (ERP) software.

linked_logo

Gaetano brings over 15 years of experience in the information technology sector covering multiple roles including programmer, software developer, system integrator and IT project management. Prior to joining ARITHMOS, Gaetano was a Project Manager for a European IT company, responsible for the implementation, startup and development of management software and web solutions. He also has expertise in software project analysis and consultancy for the implementation and development of business management software.

Gaetano is responsible for furthering the development of ArithmosCentrum, ARITHMOS’ proprietary ERP software that manages the information flow between sales, project management, finance and resourcing for any project-oriented service provider. ArithmosCentrum is a unique ERP system in that it improves project governance by incorporating project management and back office tasks and linking the project plan to the budget proposal and resource schedule and is customizable for specific industry or company needs.

In addition to his work on ArithmosCentrum, Gaetano will also apply his knowledge and expertise to the continuous development of Symphony – ARITHMOS’ customizable and cost-effective electronic data capture (EDC) solution offered as a SaaS (Software as a Service) solution.

About ArithmosCentrum

ArithmosCentrum is an Enterprise Resource Planning (ERP) designed for any project-oriented service provider wanting to improve project governance. From the basics of timesheet management through to the more complex processes such as cost proposal preparation and resource scheduling, ArithmosCentrum helps you improve efficiency and communication while minimizing administration time.

Disaster Recovery Planning: Is your Company prepared in the New Year?

recoveryHaving an effective and simple disaster recovery plan is essential for any company from an IT and business perspective. Is your company prepared for the upcoming year? ARITHMOS takes you through the essentials of disaster recovery planning.

Disaster recovery planning is absolutely essential, especially in an industry dealing with large amounts of data such as pharmaceuticals/healthcare, energy and gas and financial sectors. In cases of Disaster Recovery, most companies fail to understand the importance of IT services and personnel from a business perspective. As companies grow globally, they need to know exactly what IT services they are capable of providing, at what costs and what risks are involved in the geographic expansion.

What would the consequences be for you, your company and your clients if your IT shut down for an hour? For 2 hours? For a whole day? What would be your quantifiable losses? Who would be in charge of initiating data recovery? A good disaster recovery plan will involve all departments related to IT service and business activities to evaluate risks and costs.

A good disaster recovery plan starts with analyzing the risks…

The plan should start with a basic risk assessment of the physical location of a Data Center. Avoid building a Data Center where there is high risk of natural disasters. Human error is a different story. Employees can accidentally trip the power or delete important data. The first step in Disaster Recovery planning internally is to know your office building and employees and what can be prematurely avoided.

…and keeping business as usual…

A good Disaster Recovery plan will be well detailed within the “business continuity” plan. Can a company continue providing business-as-usual services while the disaster recovery process is in place?

DRP…by knowing your IT service capabilities…

The Disaster Recovery plan should identify priorities in terms of IT services – what is important and what is absolutely essential. Knowing the priorities of disaster recovery can help to:

  • Define levels of service needed
  • Estimate recovery time
  • Create a method of recovery

Once you have determined the priorities, the most important analyses will be the RPO (Recovery Point Objectives) and the RTO (Recovery Time Objectives). The RPO will establish how far back services will have to go to find recoverable data, and the RTO will determine how much time is needed for recovery. The Disaster Recovery plan must then be maintained through proper documentation and system validation.

A quick note on Computer System Validation

Computer System Validation (CSV) is a documented process for assuring that a computer system does what it is designed to do and CSV should be a part of your Disaster Recovery Plan. There are two important reasons for performing CSV on technologies and software: (1) CSV can prevent problems before reaching the usage environment, and (2) Not performing certain CSV in accordance with Best Practices could be against the law in certain industries.

ARITHMOS has extensive experience in providing consultancy for Disaster Recovery Plans and Computer System Validation. ARITHMOS can guarantee quality and secure hosting as well as data integration services and data center replication. To consult ARITHMOS’ experts, submit a request form or email us at info@arithmostech.com.