Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it? Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter). In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process. Let's take a look at some of these key, yet often forgotten, areas.
1. Review Past Performance
Although reviewing a site’s past performance seems simple enough, many study sponsors do not invest the time and effort to do this. It is vital to review your sites' past performance in order to have a better indication of how they'll do in future studies. This type of information can be aggregated into a type of site business intelligence database developed in-house or via a vendor.1 Most study sponsors already have this information and, when it is used properly, it can drastically improve the chances of selecting the best sites in the future. In reviewing a site's past performance, some of the things that should be highlighted are:
Enrollment is one of the key performance indicators for how a site performed in a clinical trial. Although at times there are factors that contribute to enrollment that are beyond a site's control, it is still important to review how a site did regarding its planned versus actual enrollment targets in the past. If there were reasons beyond the site’s control for missing enrollment targets, such comments should be captured in a site business intelligence database. Protocol complexity, parameters of inclusion and exclusion criteria, and overall barriers to patient participation are just some potential reasons for missing enrollment targets beyond the site’s control. Regardless, this key performance indicator should still be captured by study sponsors for future decisions.
Quality of Data
There is one fundamental thing a study sponsor wants to know from an investigator site it has used – was the quality of the data it provided for the study good for a future submission to the health authorities? This question should trigger additional questions, including: Was there an above-average number of queries that needed to be resolved by the site? Does the site use technologies such as eSource and eReg, which can help to ensure better data quality, compliance, and acceleration of the study start-up process? What was the overall quality of the data the site provided? By asking these questions and capturing the responses around a site’s past data quality, sponsors can be better equipped for future decisions regarding a specific investigator site, even if only to address the previous issues before engaging in future collaborations.
Ease of Working With The Site
Despite hard science and data being king in clinical trials, it is the soft and often subjective topic of people and relationships that can support or completely destroy the former. Within the topic of strategic site selection, the ease (or not) of working with a particular investigator site should absolutely be noted by study sponsors for future decisions. This one point may not always be a deciding factor, but, depending on a study sponsor’s objectives for a particular study, it could very well be. If a site is very difficult to work with and has average to low performance, it may not be a good decision to employ the resources and time to engage such a site. However, study sponsors should remember that the pendulum swings both ways when it comes to this topic.
2. Review Past Start-Up Times
Start-up times should be high on the list of actions for strategic site selection. For each day that an approved drug is not in the market, between $600,000 and $8 million2 in revenue are lost to study sponsors. Although it’s not the only factor contributing to study start-up delays, a site’s start-up timelines have a direct impact on this and should be carefully considered in a study sponsor’s strategic site selection process. It is also important to look at any unique situations that directly impact a site's start-up timelines, such as specific ethics committee approvals, sequential or parallel processes, agreement by other entities prior to engagement, etc. A common example would be when a site may need a particular approval prior to engaging in any trainings related to the study protocol or sponsors’ systems. Depending on your study objectives, a good performing site that has an extensive study start-up timeline may not be the best fit for a study that needs to be completed quickly.
3. Review Site Costs
As one of my all-time favorite topics, site costs are one of the most overlooked areas when it comes to site selection. With high drug pricing under increasing scrutiny, the ability to look at ways to lower clinical development costs is both needed and smart. By reviewing a site's costs in conjunction with the other previously mentioned areas, study sponsors can potentially play a vital role in drastically decreasing clinical development costs while obtaining the best return on their investments (ROI). The alternative to not doing this results in study sponsors engaging many times with low-performing, high-cost sites. Key site cost information, such as overhead costs, standard fees (administrative or otherwise), and other unique costs is vitally important for study sponsors to capture and use for strategic site selections.
As you implement these key and often forgotten actions within your strategic site selections process, in addition to increasing your chances at selecting the very best investigator sites for your clinical trial, you may be surprised to see new sites that you had not previously considered emerging on your list, due to their performance, start-up timelines, and costs. Site selection is a robust and extensive topic that requires a thoughtful strategy to generate great results.
For further discussion of these strategic site selection strategies, check out the video “3 Key Areas of Strategic Site Selection.”
About The Author:
Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. Her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, fair market value, and global investigator site payments. Araujo’s passion for driving practical change in the industry led her to launch ClinBiz, an online platform where clinical research professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials.