Introduction to the site selection process
Clinical research organizations (CRO) predominantly rely on the internal networks and investigator database to support a clinical study for a drug. As the clinical sphere continues to expand at a rapid pace, there is an upsurge in demand for clinical trial sites worldwide. CROs are striving for new sites to perform their clinical study. In the United States alone, the number of trials has quintupled (from 48,295 to 288,728) over the last decade, and almost half the sites fail to achieve their objectives, causing expensive trial delays and increased cycle times.
The global clinical research market is predicted to cross $65 billion USD by 2025 . The key drivers impacting this exponential market growth are globalization of clinical trials, development of personalized medicine, and enhanced evolution in technology. In such challenging times, selection of an appropriate site becomes extremely important for a successful clinical trial. It is imperative for an organization to identify sites with the expected set of patients who meet specific medical conditions to have a productive trial.
Complexities in Site Selection Process
Site selection process requires the application of analytical and qualitative techniques to determine the most favorable location for a clinical operation. Over the years, several factors have emerged such as globalization, fast-track approach, and strict environmental legislation, and scarcity of skills that make site selection an increasingly complex process.
Here are some of the most prevalent errors that can occur during the site selection process which often undermine corporate location strategy leading to risk, higher cost, and unfavorable operating conditions.
- Impromptu Site Selection Team: Usually, a well-organized team possess core competencies in the areas of human resources, accounting, logistics, engineering, construction and environmental issues. Neglecting to garner the right mix of stakeholders and experts early in the process unquestionably increases the risks of project delays and poor location selection.
- Novel Site area: New site selection is usually done by carefully considering the transportation issues, capital needs, and other market dynamics. Complications arise and valuable time is lost if the location is not validated with the new facility’s overall operating objectives and criteria.
- Poor Technical Site Review: Each year, CROs experience unforeseen circumstances, such as adverse geotechnical conditions, hurricane issues, and various other hurdles that can be avoided. Before choosing the desirable site location, it’s crucial to understand and measure environmental risk, obstacles to development, and topographically variable construction costs
- Breach of Privacy: Project privacy protects owners from unsolicited attention and distractions, which can influence the outcome of the study. The site selection team must take every possible measure to shield the corporate identity and the nature of business to third parties who may not have the firm’s best interests.
Strategies to Accelerate Site Selection Process.
Implementing Virtual Trials Can Effectively Reduce the Time and Need for Site Selection
One of the best ways to accelerate and overcome the challenges of incorrect site selection is to opt for a virtual trial. After the covid-19 pandemic indefinitely interrupted the clinical trial processes, companies are compelled to adopt a virtual approach in conducting trials. Virtual collaboration has become the new norm in continuing the drug development lifecycle. These remote trials allow patients to transmit remote, real-time data to the centralized study site (where trial staff work).
CTMS plays a chief role in virtual trials by assisting the trial staff to process the data received from patients through wearable devices. This information might include data about a patient’s sleep duration and quality, blood pressure, blood sugar, metabolic activity levels, and heart rate.
Virtual trials “effectively eliminate” the need for selecting, activating and maintaining trial sites while conducting a trial directly from a patient’s home.
CTMS Makes Site Selection More Transparent
Data must drive site selection to boost the chances of a successful study, which requires the integration of multiple internal and external sources of site and investigator information. The Collated data should comprise of survey responses, site experience, start-up cycles and patient enrolment.
Several industry associations have been established to help aggregate data and make it available for better site selection decision-making. This data, besides the software, allows trial managers to develop a valuable and reliable site selection strategy in the start-up process and cycle times. CTMS also supports in gathering regulatory and financial data much faster, thereby adding transparency in site selection process and potentially accelerating start-up timelines.
Machine Learning Software
To run a successful trial, you need to devise a strategy to consider whether the site has access to recruitable patients, sufficient infrastructure and is the correct site for the therapeutic condition under study. Selecting patients according to the correct inclusion/exclusion criteria is vital to keep them enrolled until the trial ends. And once the patients have been recruited, principal investigator needs to continuously monitor the data accuracy and check if the protocol is being followed.
To analyze, process and record all of this information manually would present a substantial burden on time. AI-based Machine learning software can efficiently carry out the trial management process. AI can rapidly provide insights to tweak the selection parameters as well as analyze reports in a timely manner. It would then be able to accurately predict a favorable trial site and make other significant decisions, based on analysis of historical data.
Review Past Performance
Despite the fact that reviewing a site’s past performance is an easy process, 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 understanding of how they will operate in future studies. It is imperative to understand the overall quality of data the site provided. This type of information can be aggregated into a type of site business intelligence database developed in-house or via a vendor. By capturing and recognizing the site’s past data quality, sponsors can be better equipped for future decisions regarding a specific investigator site, which can drastically improve the chances of selecting the best sites in the future.
There is no particular ‘best’ site selection process. Site selection is a complex and extensive subject area that requires a thoughtful strategy to generate great results. The technique you eventually end up using will depend on the particular challenge you face on your way to conducting the trial which will most likely be specific to particular features of the trial. As you implement these key and often undervalued strategies within your site selection process, you not only increase your chances at selecting the very best investigator sites for your clinical trial, but you may also notice new sites that you had not previously considered emerging on your list due to their performance, start-up timelines, and budget considerations. You could serve others once the study is complete by providing sites with a comprehension of their performance by gauging areas for potential process improvements and providing insights on best practices to drive further improvement.