The site selection is crucial to the outcome of a clinical trial; it has the power to either make or break it. A clearly defined evaluation criteria taken from the research design makes it easier to identify and compare suitable sites so that the best possible one is selected.
The geographical location and the local population are among the most important factors to consider when choosing a site. Other factors revolve around the site staff, facility requirements, the study duration and target timelines.
Factors to Consider
Take into consideration the staff availability, their credentials, their experience in clinical research and how their performance adheres to regulatory and ethical guidelines.
Facilities and Equipment
Does the facility have adequate space available for the clinical trial, drug and device storage space, storage of important documents and equipment needed for the study?
Site Profile and Timelines
What kind of site is it? (hospital, clinical, non-profit, government or private site), what is the site’s Institutional Review Board (IRB) meeting timeframe and contract negotiation timeline?
Population Profile and Access
Takes into consideration the eligible participants availability and proximity to the site, their condition, any similar ongoing trials, recruitment capabilities and the resources available for conducting research.
Look into the past clinical trials conducted at the site, especially trials that had similar enrollment timelines, enrollment targets and past enrollment rates.
Look at any current trials which target the same population profile. Are the trials taking place in close proximity to your site? (This would have an impact on participant recruitment).
Is the site located in a central area that is easy for participants to get to? Is it close to amenities, including public transport, airports and hotels (for interstate and international participants)?
Assessing the Site
Points to consider when visiting the site:
- Are the investigators engaged? Do they have insightful questions?
- The general appearance of the facility (space available, etc).
- Are evening and weekend sessions available?
- Does the site have any extra initiatives? (Do they have a research patient group? How do they support participants during a trial?)
- What is the feedback from past clinical trial participants?
- The site should keep data metrics.
- If a sponsor has worked with a site previously, they should check to see whether key staff are still working there (the loss of staff can have an impact on the clinical trial).
- The site offers webinars and training which shows that they are committed to delivering research at the highest standard.
Early Phase Trials: Best Practice Checklist
In March 2020, the ‘Early Phase Trials: Best Practice Checklist’ was launched in Australia which provides guidelines for the Australian clinical trials sector. Although it is branded as ‘early phase trials’, the checklist can be used for all phases of clinical trials.
The guidelines include:
- Research Guidance Documents: The site has access to the relevant documents, and is kept updated about any future developments in research policy.
- Safety Management: The site has access to appropriate safety measures and has a highly capable clinical safety data management system.
- Staffing: The site complies with safe workplace practices, and the staff has the relevant training and experience needed.
- Facilities: The site has efficient processes in place to manage site equipment and has adequate participant and administration facilities.
- Device Handling: The site has a highly effective investigational device handling practices in place.
- Quality Assurance and Quality Measures: The site has an Internal Quality Assurance procedure, effective evaluation processes in place and a Corrective and Preventive Action (CAPA) procedure.
- Participant Engagement: The site conducts participant orientation, provides general information to all participants, keeps participants updated, and has relevant Standards of Procedures (SOPs) in place.
- Pharmacy: The site has access to a pharmacy that has the capability to meet study requirements.
- Laboratory Requirements: The site is responsible for processing biological samples and carries out safe laboratory practices. They also have the necessary equipment on-site and follow correct sample handling procedures.
- CTRA (Clinical Trial Research Agreements): The site utilises standard templates for agreements, sponsor specific clauses and third-party vendors. The site also has the budget to cover all research costs.
Process for Selecting the Right Site
- Once a potential site has been identified, the Principal Investigator (PI) is sent an enquiry for clinical trial participation which includes a study synopsis to assess interest and request the site’s CV.
- A successful site’s CV will include:
- Evidence of Good Clinical Practice.
- Staff member’s CVs, roles and experiences.
- Training certificates for EDC (Electronical Data Capture).
- Equipment calibration certificates.
- IMP (Investigational Medicinal Product) temperature monitoring SOPs (Standard Operating Procedures)
- Details of the electronic system used for patient records.
- Number of patients the site has access to.
- Details of past performance - percentage recruitment to target, retention rate, First Patient, First Visit dates met (FPFV)
- How long has the site been involved in trials and what phase trials are they experienced in conducting.
- Audit findings.
- Directions to the site and parking information.
- A successful site’s CV will include:
- If the PI is interested, set up a Non-Disclosure Agreement (NDA) (a contract where one or more parties agree not to disclose confidential information).
- Once the NDA is completed, the study protocol can be shared with the PI and a survey that addresses the pre-defined criteria can be provided to the site. The questionnaire can be submitted to an online survey system which can allow results to be compared and can produce results that can be easily exported to a spreadsheet.
- Discuss contracting and budgeting with admin staff early on in the process.
- Prestudy visits (PSVs) and Site Selection Visits or Site Assessment Visits (SAVs) are conducted by Site Monitors.
- A meeting is conducted to establish a relationship with the PI and site staff and to explain the study in more detail, including study objectives, overall design, procedures and endpoints.
- After all the relevant information has been collected, reviewed, and evaluated an objective comparison and decisions can be made.
- After a thorough evaluation, the final sites are notified of their selection for the trial. (CTAs (Clinical Trial Approvals) are sent to each site and documents can be prepared).
Important Things to Remember When Selecting a Site
- An unbiased and systematic review of the site’s compatibility with the study needs to take place.
- Proper site selection is not the sole factor for site performance and study success, although it does play a crucial role.
- External forces can challenge study conduct (clinical trial design, protocol, difficult to meet inclusion/exclusion criteria, supply chain demands, cultural and technological considerations).
Interaction Between the Clinical Trial Sponsor and Study Site
Expect a Site Initiation Visit Before the Study: A representative from the sponsor company will go to the site and introduce key staff to the study, answer any questions and make sure they’re prepared for the upcoming trial.
Prepare for Visits by Monitors: Monitors (auditors from the sponsor company) regularly visit the various research sites employed by the sponsor to ensure that required processes are being followed.
Sponsor Support: The sponsor is there to guide the research site through the clinical trial. It’s their job to ensure that a site is well-informed. The sponsor is also the first person who should be informed about any legal, ethical or structural issues that may arise during the trial.
In 2015, the Australian government established a standard table of costs to help sponsors accurately calculate the cost of conducting clinical trials in Australia. This table of costs has made the process of negotiating contracts with sites much easier and more streamlined.
For over three decades, the international pharmaceutical, biotechnology and medical industries have relied on Australian clinical trial sites to deliver reliable, timely results while meeting the highest quality and ethical standards.