Sponsor Return on Investment

ePRO solutions help trial sponsors collect the best quality patient data possible. But how do you quantify what high quality data is worth? What processes does ePRO replace, and what work does it create? The ROI for an ePRO trial depends on a variety of factors but it can be calculated and used as a strategic competitive advantage.

Doing More with Less

Patient data collected by ePRO systems have been shown consistently to reduce the variance of data collected on paper. This means that studies can be powered with fewer patients, saving significant time and cost. Published studies that have shown this benefit of ePRO span several therapeutic areas:

• Insomnia

  35% smaller standard deviation on the LogPad yields study power with 56% fewer patients and a potential savings of $340,000 (Merck case study based on poster presented by Pearson et al. at ISOQOL 2005)

• Constipation

  Interrupted study showed drug efficacy with 322 randomized patients, as opposed to the plan of 1,026 (Johanson et al., poster presented at World Congress of Gastroenterology 2005 by Novartis)

• Urinary Incontinence

  Comparing an eDiary trial to a previous trial with the same endpoints, the eDiary trial showed a reduction in standard deviation by 33% for incontinence episodes and 30% for voluntary voids (McKenzie et al., "Proving the eDiary Dividend," Applied Clinical Trials, June 2004)

In all of these examples, high-quality ePRO data provided tangible benefits by reducing the number of subjects needed to prove efficacy (estimated Merck savings: $340,000) as well as the potential to reduce patient recruitment costs and time.

Paper Doesn't Grow on Trees

While ePRO solutions rely on PDA hardware as opposed to paper, there are often forgotten costs associated with paper trials which are eliminated by ePRO. In most cases, thorough analysis of all the costs (and additional processes) relating to paper diaries show that ePRO and paper methods are approximately cost equivalent. Costs associated with paper that are eliminated or replaced by ePRO:

• Queries on diary and/or questionnaire data
• Double data entry
• Data management and extra sample sizing costs to deal with missing and illogical data
• Storing and archiving paper data
• Site and CRA time to review handwritten diaries or perform complex calculations
• Printing, reprinting and shipping all paper diaries
• Data management time spent on trial cleanup after LPO

Faster Time from Data Collection to Data Analysis

With high-quality ePRO data, there is no need for intensive cleanup by data management once the trial has been completed, which can delay database lock for 2-4 months. LogPad trials typically lock the diary database within a week of the trial's completion, thereby saving time, money and opportunity costs. This leads to faster Go/No-Go decisions for Phase II trials and faster analysis and NDA preparation for Phase III trials. Additionally, for sponsors using EDC systems, paper diaries become the rate limiting step in the trial process. ePRO, conversely, allows sponsors to take advantage of the full benefits of running eClinical trials.

The Cost of Safety

Real-time data access can greatly enhance patient safety, whether by study coordinators and CRAs monitoring symptom data on a daily basis or through an advance email alert system. By keeping better track of health status changes, worsening patients can have medications or dosages changed, be taken off the study, or put into a different group. Real-time access to PRO data improves safety monitoring for all trial participants and reduces sponsor cost by averting the issues that could arise from delayed access to study data.

Remote Monitoring

In additional to real-time patient data access, StudyWorks lets CRA's perform remote monitoring of the trial. This means they spend less time traveling and monitoring sites in person, and reduces trial management costs.

The Bottom Line

The ultimate return on investment, of course, is an approved drug, treatment or therapy developed rapidly and before the competition. ePRO data enables better scientific conclusions because the data is valid and trustworthy to regulatory authorities, which may prove to be the difference between an approval and a request for more data.

Learn More about ROI

Where can I read more about ePRO reducing data variance vs. paper? I always assumed eDiary trials are more expensive than paper ones - can PHT help me estimate my costs more accurately? What other opportunities for savings have other companies using ePRO experienced? Contact PHT for answers to these questions or any others you may have.