Site Feasibility: Increasing Speed to First Patient in and Maximizing Enrollment Potential  

With thorough site feasibility processes, sponsors can increase speed to first patient in and maximize enrollment potential.

According to Pharma Intelligence Informa, two-thirds of all clinical trial sites are unable to meet enrollment goals. Half of all sites recruit one or zero patients. 

Even for trials that ARE able to meet recruitment goals, 86% experience delays, with actual enrollment timelines typically 2x their planned estimates (averaging 8 months to initiate a trial from site identification to first patient in). 

These are daunting numbers. What can a sponsor do to minimize the risk of delays, enrollment failures, and sunk costs? 

Selecting the Right Sites: Best Site Feasibility Practices 

A well-planned study with properly selected sites can decrease costs and speed up the study timeline 

Poor enrollment can lead to the need to seek out and bring in new investigators, drawing out timelines. It may also require an adjustment to eligibility criteria, and protocol amendments may move a study several steps back.  

At the very least, underperforming sites add extra opportunity costs. 

At the worst, a study’s target enrollment may never be reached, and your entire program may be compromised. 

During the site selection process, sponsors/CROs should consider the following (uncomprehensive) list: 

  • Assessing general site feasibility questions 
    • Are there any regulatory red flags?
    • Does the site have the right resources (equipment, staff, etc.) to allow the trial to be successful? 
  • Assessing epidemiology and patient population 
    • Is the site located in an area with a high incidence of the disease of interest? 
    • Does the site have access to the targeted patient population? 
  • Assessing historical performance site-by-site 
    • Does the site have successful experience within clinical research? 
    • Does the site have efficient regulatory, contract, and budgetary processes? 
    • Does the site have successful experience within the study’s therapeutic area? 
    • Does the site have a history of meeting enrollment goals?
  • Assessing experience of investigators and site staff 
    • Does the PI/site staff have experience within the study’s therapeutic area/indication? 
    • Does site staff have the bandwidth to take on more studies? 
    • Does the investigator have a vested interest in the condition? Is it an area of focus for their practice, or are they recognized as an expert? 

Leveraging Big Data, Experience, and Niche Expertise  

In addition to the more traditional criteria that are evaluated as part of the site selection process, there are several techniques and innovations that can be used to ensure a sponsor is selecting the right sites.  

At PharPoint Research, our team is able to consider or implement the following techniques: 

Using big data and learning algorithms to optimize site selection 

PharPoint uses the robust data from Informa Pharma Intelligence’s Citeline in order to identify high-performing sites. 

Citeline is a comprehensive data and analytics tool that contains information on 470,000 investigators and 163,000 sites by trial type. The information collected by the PharPoint team from this robust database allows us to generate a tiered list of sites and PIs with the right experience and qualifications.  

The objective information obtained from Citeline is just the first layer of input analyzed by the PharPoint team.  

Leaning into extensive team and site feasibility experience to provide accurate enrollment forecasting 

There is no alternative to an experienced team. 

With senior team members within clinical operations averaging over 20 years in the industry, our project managers, clinical leads, and strategists can use their informed expertise to make more subjective analyses. Additionally, our team’s extensive industry experience and working history with investigators allow us to make informed decisions based on first-hand experience. 

Is early communication with the site/point of contact (POC) for the site bringing up any red flags? Does the PI seem motivated and enthusiastic about the investigative therapy? If the study is being conducted with decentralized aspects, does the site seem prepared to use the required technology (evaluating experience, attitude, current technology usage, etc.)? 

Evaluate cross-functional input 

Early in study planning while evaluating site feasibility, it’s important to consider cross-functional input. This is especially true in the time of decentralized trials and digital solutions. Depending on study details, certain stakeholders may need to be given more weight than others.  

Examples of input that should be considered while selecting sites includes: 

  • Insight from clinical operations experts who are heavily, regularly involved in site selection and management and can provide strategic insight based on decades of experience 
  • Insight from data management and systems vendors regarding site infrastructure required to support digital/decentralized solutions 
  • Insight from sponsors and other key therapeutic area experts, who can provide lessons learned from the successes and failures of past similar trials and provide a deeper understanding of the target patient population 
  • Insight from investigators who may be able to provide additional site/investigator referrals

Strategic judgment that involves insight from all involved parties can help de-mystify the best path forward, eliminating prospective sites who may not have the right experience or capabilities for your trial. 

Working with niche partners for specialized recruitment efforts 

In some instances when dealing with particularly hard-to-reach subjects, collaboration with a patient recruitment partner can allow for rapid enrollment. 

 Industry reports have found that Sponsors are increasingly interested in bringing in specialized patient recruitment and retention vendors for their trials, and a truly client-focused CRO should be able to lean into these partnerships if it is determined that they can bring added benefit to a study.  

According to data by ISR Reports, 70% of large sponsors (recognized as companies that spend over $1B annually on R&D) and 55% of nonlarge sponsors agree that they will be increasing the use of specialized patient retention companies in 2021 and 2022.  

The PharPoint team maintains relationships with specialty partners who bring our clients added success through the use of innovative technologies & niche expertise. Many of these partners have worked with the PharPoint team since PharPoint was founded in 2007 as part of our best-in-class vendor model.  

PharPoint leverages extensive industry expertise to make knowledgeable, long-term cost and time-saving recommendations for a client’s program—and part of this consultative approach includes understanding where bringing in a niche partner may be valuable to clients.

 

Conclusions 

While there is no one-size-fits all method to ensure your study meets enrollment goals, there are actionable steps you or your CRO can take to mitigate the risk of choosing the wrong sites. 

To learn more about PharPoint’s experience within site selection and timely patient enrollment – including a recent case study evaluating some of the key actions we took to speed up enrollment timelines for one study by 5 months – contact our team. 

 

References

Download a copy of the Site Feasibility Whitepaper