Strategies for Successful Site Selection in Clinical Trials

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Statistics show that 80% of clinical trials require additional time to meet their enrollment targets and timetables owing to recruiting or other difficulties. Choosing clinical locations that match the unique demands of the research is a critical component of a risk mitigation strategy for avoiding some of these difficulties. Choosing locations that meet the protocol's details and the sponsor's regulatory goals and strategies has a direct influence on the quality of the data produced, research schedules, and total project expenses.

In this article Octalsoft outlines critical strategies for selecting the right sites, evaluating historical site performance and feasibility, and implementing improved communication and tools across stakeholders to ensure sponsors maximize the time, resources, and money associated with each clinical trial. So without further ado, let’s get to it.

Clinical trial site selection. Here's how the procedure works:

The first step in determining the feasibility of a location will be to investigate the study's unique requirements. Then comes the process of finding potential sites. In this stage, data is obtained from the site and compared to the trial's requirements. A further study and comparison can then take place based on a selection of suitable places.

Step 1: Identify and Define the Study Requirements from the Site

Both the sponsor and the study will have particular requirements that must be met. Following that, each criterion and sub-criterion required to achieve these demands in a timely and cost-effective manner must be determined.

Items must be categorized as priority, negotiability, deal-breakers, and show-stoppers. This stage will provide CTOs with an awareness of where they may be flexible and what the consequences will be. Using weighted criteria whenever possible will result in a more natural and manageable output in the form of a rating system for potential sites.

This phase necessitates the availability of precise information on the research design and methodology in the decision-making process. Before you can begin identifying and choosing sites, you must first understand the study's projected duration, patient demographic profile, enrollment objectives, preferred locations, and timetables such as start-up and recruiting.

Without this information, it will be hard to get closer to a suitable site, much alone comparing them. Once this information is accessible, it is much easier to break down the study's demands into an evaluation plan with assessment points that can establish a site's appropriateness.

These criteria should be chosen not only because they are relevant to the study, but also because they are reasonably objective indicators that can be easily compared across locations. They will very certainly vary based on the proposed research, but the most frequent and beneficial will almost certainly include:

Personnel - This will need to address the credentials needed for the trial, the specializations and skills, research experience, and regulatory compliance performance of the site's staff.

Facilities - The amount of space required for the trial, secure and acceptable product storage, research equipment required, and accessibility for delivery.

Access to Population Profile - Perhaps most crucially, how close the site is to the target population. If there are any active trials targeting the target population, as well as the site's outreach skills.

Past performance - Previous enrollment in comparable trials or trials with similar enrollment timeframes is more relevant than a strong history of participation in unrelated studies.

When the available information about the site design includes a clear list of needs and assessment criteria, comparing sites against it and with one another becomes much easier. The more time and effort put on this phase, the smoother the subsequent steps will be.

Step 2: Making First Contact with Sites

It's time to start finding sites with a list of stated criteria. This process is casting a wide net and gradually limiting it down to the best alternatives. There are numerous approaches to this, but it's typically best to start with the simplest and cheapest, gradually increasing diligence and expenditure as needed.

This is a pre-selection step, so seek platforms or sites that include filters to assist you in identifying sites based on factors such as location, size, and specialty. Data on previous experience and performance should also be available, which may reveal certain compatibilities with the intended research.

A research summary can then be distributed to possible locations, and the process of developing a shortlist can commence. This initial contact might request their résumé and allow the site to register their interest in the research. If the answer is good, an NDA is usually signed so that further information about the research can be revealed.

The research protocol and a questionnaire related to the criteria set in step 1 should next collect the relevant data. As we shall see in the next part, online forms offer several advantages over paper forms, but the main purpose is to acquire the essential information from the site to compare it to others.

One of the primary causes of delays in this case is ineffective communication. It's debatable if a sluggish response is a symptom of bad site organization (and hence a red flag), but a good clinical trial strategy software system for connecting with sites can come in useful when it comes to pursuing the information required.

After this procedure with numerous candidate sites has been finished, and those considered inappropriate have been discarded, the process comes down to comparing and picking amongst what's left.

Step 3: Comparing, Visiting, and Selecting a Site

This is the next level of engagement with locations, where expectations may be established early on and deadlines can be examined and discussed. Forecasts of setup costs, overhead percentages, clinical supply chain strategy, and close-out fees can be used to create budgets. This may be done as a uniform template to ensure that everything is accounted for and displayed equitably. Site administration personnel should be included in this process from the beginning, and site visits should be scheduled.

At this point, certain sites may stand out, while new information will eliminate others from the list. Site visits should fill in any gaps in the essential information and offer a chance to begin creating the required connections to get the most out of the arrangement. This visit will ensure the sponsor that the location is capable of conducting the study.

Finally, before official agreements are signed, a full and objective comparison of locations may be done, and the final selections can be told of their selection. This procedure can be time-consuming, but there are several technology alternatives available to make it faster and easier.

Pro Tip: Research Site Visit Checklist

This checklist should cover the major things to consider when selecting a site, some of which have been touched upon already. 

Practical considerations:

• Geography 

• Population profiles

• Study design

• Ethical Considerations

• Timelines

• Environment 

Facilities Considerations

• Suitable facilities

• Storage 

• Nearby Pharmacy

• Flexible access

Recruitment Considerations

• Staffing qualities

• Technologically literate

• Establishing trust

• Staff availability

Regulatory Considerations

• Check site history

• Outsourcing

• Staff turnover

These considerations can be expanded upon given the specific details and nature of each trial, but the four categories cover most of the bases for padding out a research site selection checklist.

Conclusion

Clinical trial site selection and CTM strategies are often ignored requirements in trial preparation, and site selection for clinical trials frequently comes down to familiarity rather than the site's ideal suitability for the planned research.

This may lead to major losses in patient safety, human and financial resources, and time to market, but perhaps most significantly, it can have a disastrous effect on recruiting. As a result, site selection for clinical trials should be methodical and informed, depending on the unique demands of each experiment.