Article | May 1, 2012

Improve Your Site Rating Through A 'Less-is-More' Approach

Source: Forte Research Systems, Inc.

By Laura Youngquist, Director, Allegro Product Management, Forte Research Systems

The oft-cited adage of "less is more" can be applied to several different concepts, but it is certainly an apt phrase in the context of study selection by sites. There exists the temptation by some to take on as many studies as possible in an effort to gain recognition of its work among sponsors. However, there are pitfalls associated with this approach if sites cannot successfully manage an inflated trial portfolio, demanding extensive resources. In contrast, a conservative and considerate approach to study selection can achieve greater overall benefits for sites.

Christine Pierre, President of RxTrials, a network of premier clinical research sites, and who has more than 20 years of consultation experience with site directors, states, "Sites are often afraid that if they turn a study down, for any reason, the sponsor or CRO may not come back to the site with future opportunities," she said. "Nothing could be further from the truth. The partnership between the sites and sponsors and CROs is based on the need for complete honesty from the site regarding their ability to successfully conduct the study with high quality and meet enrollment targets."

Critical Questions for Study Evaluation
The benefits of carefully selecting studies include an improved site rating (recognition by sponsors for being a well performing site), gaining preferential access for selecting from desirable studies, and more leverage in payment negotiations with sponsors.

A couple important questions a site should ask during the evaluation process include:

  • Can we meet the patient recruitment goals?
  • Can we recover our costs?

Patient Recruitment
A site's ability to successfully recruit patients will increase its overall rating and set it apart in an industry plagued by failed accrual targets. According to the Tufts Center for the Study of Drug Development, two-thirds of sites do not meet patient enrollment requirements of a given study.

When a site continuously reaches accrual requirements, it establishes itself as a well performing site among sponsors, which in turn increases its access to promising studies.

Of course, this is easier said than done. However, some existing technologies can be utilized to help put this into practice. Some electronic Clinical Trial Management Systems (CTMS) come with patient recruitment functionality such as configurable search parameters to help identify subjects within a patient population that might qualify for a protocol.

Cost Recovery
The ability to meet accrual goals also extends to the next important consideration: the ability to recover costs associated with study conduct. This plays into the overall financial picture for a site; therefore, a site should account for all costs up front when evaluating a study. This includes "hidden costs," such as overhead fees related to the pharmacy and lab or personnel time spent in subject visits and monitoring visits.

Hidden costs per subject or visit are also an important part of cost recovery, especially when planning to over-enroll. Consistently including incurred per-subject visit costs, such as coordinator fees or archiving fees, can ensure the site comes out ahead by the end of the study.

Consistency across trials with budgets that are known to work effectively is helpful but can be difficult to achieve due to a lack of access to past information. Functionality helpful for evaluating the financial viability of studies and facilitating budget negotiations includes:

  • Master lists of charge events to help maintain consistency and avoid missing items as the budget is developed
  • Budget creation tools that are integrated with the protocol calendar as well as the institutional charge master to facilitate fast and accurate budget creation.

Defining Growth
Peerre noted that many sites define "growth" in terms of adding more sites to their organization or adding more studies. She disagreed, saying, "The startup costs of both of these activities are quite high, as is the rate of failure.

"However, choosing the right studies for your site, meeting your enrollment goals, and providing quality data should be the ultimate goal of all sites," she said. "Your site does not necessarily need to do more studies — just better conduct the studies you have chosen wisely."

Continual diligence in the selection of studies will result in combined benefits in the form of an improved performance rating, more access to desirable studies, and a healthier financial outlook. In this case, less certainly is more.