Site selection in clinical trials is a vital part of the drug development process. Developing a drug requires a scrupulous study design and a meticulous clinical trial. But for the trial to even begin, sponsors and CROs must select a trial site, which is easier said than done. Ask any experienced life sciences or biopharma professional in the world and they will say for sure that the success of your clinical study depends on the trial site selection.
Let us give you a few statistics here to help you understand why site selection plays a critical role in the success of a clinical trial. 90% of drugs fail to move from Phase 1 trials to the next phase. Not only that, but only 13.8% of drugs reach FDA approval stage from Phase 1 testing! There might be many reasons such as poor patient recruitment, absentee private investigators, and ludicrous study design behind the study failure. But the results would be significantly different if the sponsors and CROs take utmost care during site selection.
Choosing the wrong trial site will spell doom for your study, with prolonged delays and unplanned costs. Sponsors and CROs make a lot of mistakes which will, in the end, affect their trials negatively. In our blog today, we will discuss the common mistakes that sponsors commit while selecting trial sites and how you should steer away from them for a successful trial.
Here are the top mistakes to avoid in site selection,
- Picking sites with low patient recruitment rates
- Improper evaluation of principal investigators
- Absence of onsite staff to support study
- Ignoring site’s performance history
- Choosing a wrong geographical location
- Incomplete analysis
- Ignoring target patient population
- Unrealistic budget
- Underprepared site selection team
Come, let us explore these mistakes in detail.
Picking Sites with Low Patient Recruitment Rates
Patient recruitment can make or break your clinical trial. One of the most common mistakes in site selection is choosing a trial site with abysmal recruiting rates. Low patient recruitment rates will lead to unforeseen delays in trial completion, increased costs due to difficulties in enrolling the required number of patients within set timelines and compromise the effectiveness of the study. All this will result in inconsistent and inconclusive study data.
Improper Evaluation of Principal Investigators
Among the top mistakes in site selection is the inadequate evaluation of principal investigators. PIs play a pivotal role in the success of a trial, with them being responsible for overseeing the research, patient care, and adherence to protocols. Neglecting to thoroughly assess their qualifications, experience and track record can lead to numerous issues. Inadequate principal investigators may lack the expertise needed to conduct the study, leading to protocol deviations and compromised data quality. Furthermore, their inability to engage with patients effectively can hinder recruitment and retention.
Absence of Onsite Staff to Support Study
Overlooking the necessity of onsite staff to support a clinical trial is one of the biggest mistakes in clinical trial site selection. The absence of dedicated onsite personnel will bring about a lot of complications. Staff such as research coordinators and nurses are essential for ensuring smooth day-to-day operations, patient care, and data collection in clinical study. There is a heightened risk of data errors, patient safety, and protocol deviations with their absence. This might result in a decrease in the overall quality of the trial.
Ignoring Trial Site’s Performance History
Neglecting to consider a site’s performance history is a substantial oversight in clinical trial site selection. A site’s track record can offer valuable insights into its ability to conduct a trial effectively. Failing to examine this will be burdensome on the sponsors. Sites with poor performance struggle with patient recruitment, data quality, and adherence to protocols. Such issues will delay the trial, increase operational costs and affect the study outcomes.
Choosing a Wrong Geographical Location
Selecting an incorrect geographical location for trial is among the major mistakes in site selection. The location of the site is vital to determining the success and efficiency of a trial. Numerous challenges will arise if you fail to take note of factors such as patient population density, accessibility, and regional healthcare infrastructure. While sites in areas with sparse patient population will struggle with enrolment, accessibility issues for patients and staff can hinder the smooth operations of the study. Differences in the healthcare infrastructure will impact the study’s data quality and patient care.
Incomplete Analysis of a Site
Not analyzing the trial site comprehensively is a big mistake in the site selection process which will have significant repercussions on the study. Incomplete analysis might encompass a range of factors including overlooking critical demographic data, neglecting local regulations, and disregarding competitor landscape assessments. When such elements are not analyzed properly, it can lead to trials being conducted in sites that are ill-suited for the study needs.
Ignoring Target Patient Population
Disregarding the target patient population is a critical mistake in site selection. The success of a clinical trial is inherently tied to the availability and accessibility of the specific patient demographic required for the study. If the chosen site lacks a sufficient number of patients meeting the study’s criteria, recruitment becomes an arduous task. Furthermore, the data from the study might not accurately represent the intended patient group, potentially making the entire trial inconclusive.
Unrealistic Budget
Ignoring the importance of a realistic budget in site selection is a mistake that can have serious implications on the trial. Failing to accurately assess and allocate the necessary funds can lead to insufficient resources for site operations, delays, and unable to meet trial requirements.
Underprepared Site Selection Team
An underprepared site selection team can greatly undermine the success of a trial. The site selection process requires a team with a keen understanding of the study’s objectives and intricacies of clinical research. Inexperienced team members may make inadequate site assessments, misjudge site capabilities, and might miss essential details in the evaluation process. An unprepared team will also not be ready to adapt to unexpected challenges, impairing the efficiency and success of the clinical trials.
Conclusion
Drug development is a complicated, time-taking, and expensive process, which can cost anywhere between $314 million – $2.8 billion on average. And site selection is a chief aspect that will determine the success of the trial. Therefore, it is important that the sponsors and CROs implement the right strategies for selecting sites that have the potential to meet the equipment, resources, and trial patient requirements.
At Inductive Quotient Analytics (IQA), we are committed to making site selection easy. Our clinical professionals have deep-rooted experience and are fully aware of the mistakes in the site selection process. We are coming` with a surprise soon. Stay tuned to our digital channels for an exciting update!