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International Clinical Trials

Ahead of the Game

A well-conceived preliminary feasibility assessment is a vital first step when conducting clinical studies. Information gathered during this process can help identify challenges and ensure a realistic approach to setting expectations and timelines. Feasibility studies can help bring to light potential obstacles that are best addressed early in study delivery, before patient enrolment. This article outlines some strategies that sponsors can take when planning and carrying them out.

Site Surveys

Conducting site surveys is part of a preliminary feasibility assessment that can quickly obtain information, highlight areas for discussion and inform assumptions about site capabilities. Sponsors should aim to contact enough sites to gain a representative sample of responses from countries that may be lined up to participate. This level of information may be limited when compared to a comprehensive assessment during site selection, but it will nevertheless provide a broad overview of:
  • Number of patients with general diagnosis available at a centre
  • Number of patients meeting key criteria within a diagnosis
  • Estimation of enrolment
  • General experience in an indication
  • Number of studies being conducted concurrently by site
  • Direct competition (studies with similar population and procedures)
  • Indirect competition (ongoing studies of any phase or indication, but consuming site resources)
  • Usual care clinic schedules or procedure schedules
Typically, these surveys are carried out over a short timeline – an average of 10 days. It is important to consider the most efficient method of contacting sites without burdening them with detailed survey questions that are best left to the formal site qualification process. A survey should be designed to simplify required responses and allow ease of combinability for analysis. Providing multiple methods of response (email, fax, web, telephone) can enhance yields, since it provides a diversity of response mechanisms – allowing the site to choose the most convenient method.

Insightful Response

The primary goal is to confirm assumptions about the number of sites required, the number of patients needed to be enrolled to meet randomisation requirements, and the timeline to achieve client objectives. It is tempting to ask how many patients with a particular condition the site sees in a certain time interval and, of these, how many it expects can be enrolled. However, building in conscious cross-checks, based on certain time points in the patient pathway through a trial, can provoke a more insightful response.

Surveys can also help ensure that sites have the capability to complete the study. For example, if diagnostic tests will be needed, a survey can assess if a site has access to appropriate testing capabilities, such as magnetic resonance imaging equipment, and gather general information about the logistics associated with access – for instance, is the equipment in the office under investigators’ direct control, in the same building, across the street, or 30 minutes away? More complex logistics, such as travelling significant distances for a procedure, can potentially affect participation.

Study Tools

Some studies will rely on a disease-specific questionnaire as a key outcome measure. Finding out the number of sites that use the tool in routine daily practice, or have used the tool in a study, may pinpoint potential protocol issues or training needs.

Furthermore, surveys can highlight more commonly used tools that could be alternatives to the proposed instrument, as well as local or national guidelines that are in conflict with protocol procedures. In general, identifying clinical trial requirements that fall outside the norm for sites is important in order to assess the impact on site or patient interest.

While preliminary feasibility is not site qualification, it is a good starting point to assess level of interest, provide benchmarks for the ideal site profile, and flag up major issues for design consideration, at a point when modifications can still be made.

Data Sources

Determining appropriate data sources to assess variables that may affect clinical study outcomes is also a significant component in a feasibility assessment. Data sources may include:
  • Epidemiology reports and research conducted by health organisations, including the US Centers for Disease Control and Prevention, National Institutes of Health, World Health Organization and European Commission
  • Professional societies providing treatment guidelines and classification systems
  • Competitive study landscape gleaned from
  • Proprietary investigator databases with historical information from similar studies
In addition, web searches and web listening focused on patient communities may provide critical insights into patient engagement. Disease advocacy websites and social media can be helpful information sources.

Asking the Right Questions

Throughout the feasibility process, sponsors should ask questions that can inform the design and implementation of a study, thereby avoiding major downstream operational problems. Here are five critical questions that can help outline the roadmap for clinical development:

How will the epidemiology influence the enrolment?
To help select the best locations for the research, it is essential to understand the prevalence of a disease – including the patient population and geographic dispersion – based on scientific study. This knowledge can help validate site enrolment projections.

What is the current clinical trial environment within a particular therapeutic area?
Several factors should be assessed to understand the environment in which a proposed trial will be conducted. Examples include the regulatory requirements that may apply to the planned study, and any impact these may have on its implementation; and the number of ongoing studies which may compete either directly for patients or indirectly for site resources.

How will geography impact the trial?
Geographical considerations are critical for any trial, but for multinational studies, it is crucial to also recognise cultural and language sensitivities. Analysing historical study data in this context has the potential to identify countries in which clinical trial experience relative to the current study load is high, rendering that particular region or country ideal for further exploration.

What kind of ethics approval is available?

Ethical approval is always required, but knowledge of whether a central institutional review board or ethics committee can be utilised is important – potentially leading to efficiencies in meeting the essential start-up timelines for a study. Similarly, understanding whether sequential reviews from multiple ethics committees or supporting review committees are required may make certain environments unsuitable for participation based on timeline constraints.

How will the requirements of the trial play out in a real-world setting?
The feasibility process can unearth details about investigator practices and patient preferences. During the process, there is still time to modify the trial design. For example, if a series of five patient-reported outcome questionnaires or scales as assessment tools is proposed, and most sites are only familiar with two of the tools, additional training may be necessary. Moreover, the condition’s usual care in medical practices – including clinic visit schedules – and access to proposed procedures and tests in each country that might participate must also be considered.

While feasibility and site qualification are different, there should be some overlap in the questions posed to sites, and certainly the responders to a feasibility survey can form the nucleus of sites to approach for a trial.

As sponsors continue to explore ways to make clinical studies more efficient and effective, a well-planned feasibility process can help guide study design, improve patient recruitment, and identify key factors for success at every phase of drug development.

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Bruce Smith, PharmD, is Executive Director, Scientific and Operational Strategy, at United BioSource Corporation. He is responsible for the supervision of site monitoring, regulatory operations, site contracts and site management groups in multiple UBC locations, as well as study feasibility. Bruce has 32 years of combined clinical, research and management experience, having worked on more than 50 of the top 200 prescribed drugs in the US. He was a faculty member in the Division of Infectious Disease at Hahnemann University (now Drexel University) and then a member of a private internal medicine/infectious disease practice.
Bruce Smith
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