Marked Decline in Clinical Operations Productivity

Clinical operations productivity has declined by a median of 15% since 2005, according to a recent survey from KMR Group. That decline directly represents that industry is putting in more money for what it is generating—specifically, for every $1 million spent in resources, it is getting back 902 patient visits. This is an industry-level view; some companies fare better than others. Indeed, a few have had significant recent gains in productivity. The study explored the variance, examining why some outperform.

Clinical Operations Productivity Industry Distribution

Measuring productivity for a large pharmaceutical company can be a daunting task. KMR Group, a Chicago-based consultancy exclusively focused on biopharmaceutical R&D, uses the expenditure divided by the number of patient visits to determine the clin ops investment numbers.

According to Scott Martin, principal of KMR, the company has undertaken this Herculean task every two years since 2000 and has released some other findings in regard to pharmaceutical clinical operations for 2007.

"We looked at outsourcing rates, and there is not a major change in the levels of outsourcing over the years," Martin told Applied Clinical Trials. Outsourcing consumes about half of the total resources spending in clinical operations, and that two-thirds of this outsourcing spending is for site monitoring. However, Martin noted that the companies with the higher rates of outsourcing also tend to be less productive. "Basically, the more you outsource, the less productive you are," explained Martin. The reason? Sponsors may be finding it difficult to manage the CRO and outsourcing process effectively, and sponsors are spending a lot of time fixing things and/or managing the CRO directly.

On a better note, it appears that companies that conduct more studies have a higher productivity level. "While it is a more modest correlation, it maybe be an advantage of throughput," said Martin.

Factors that don't affect productivity? Apparently, speed does not affect productivity. Even if you're faster at conducting a trial, you are not necessarily more productive. And therapeutic area complexity? Complex clinical trials may be more costly, but they offer no positive or negative impact to productivity.

Global waning?

Another interesting tidbit surfaced in the area of where the trials are being conducted. Forty percent of the patients are still being enrolled in North America. As noted, KMR monitors the total number of patient visits and does this at a protocol level, site by site by month. "We get the number of patient visits per month, even if the trial is in Poland or Bulgaria," said Martin. "It was surprising that there hasn't been a substantial decline in the North American trials. What I believe is that companies are looking to other regions, but they are not yet there and they are not finding it easy," explained Martin. "Three or four years ago, sponsors would have expected more globalization at this point in time, but it hasn't happened."

This could be a factor of the types of patients needed for the current top therapeutic areas—CNS and oncology, which aren't typically found in the emerging regions. Or it could be based on the fact that although it may cost less per patient in a global trial, the issue of finding the patient wrapped with other issues such as data collection and administrative challenges may be throwing a barrier to the predicted global warming trend.

Productivity benchmarks

The KMR report also found a 15% increase in productivity in clinical pharmacology. While clinical pharmacology overlaps Phase I and exploratory trials, Martin noticed a strong push in these first-in-man and exploratory trials as a way to make earlier decisions to further the compounds onto larger and more expensive trials. "Major pharmaceutical companies have developed creative ways to get more sufficient information to make decisions earlier in the process. And this increase shows that this creativity may be having a positive effect."

KMR and the sponsor companies measure productivity in the following areas: biostatistics, data management, medical writing, clinical pharmacology, statistics, clinical sciences, and clinical operations.

To measure productivity, KMR first works with the sponsor company to identify the dynamic or current issues, and the importance of issues have changed over time in the past eight years. After the issues are identified, the definitions are agreed upon so that true data benchmarks can be developed. At that point, data is collected from the sponsor company via a stringent querying process.

This cycle, data was collected from Abbott, Amgen, AstraZeneca, Bristol Myers-Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck Research Laboratories, Novartis, Schering-Plough, and Wyeth. The companies themselves, representing over two-thirds of the world's top 15 companies in terms of research and development, also change over the measurement cycle depending on company circumstances. The ensuing report is shared among the responding companies for internal benchmarking purposes.—Lisa Henderson