Getting accurate results in clinical trials depends on several factors and an important one among those is site selection. For executing a clinical trial successfully, it’s important to identify and work in an effective site that ensures that the patients are safe and the procedures are effective. While selecting a site for clinical trials, several things need to be considered like availability of suitable patients, experienced staff, track record with previous trials, diagnostic and therapeutic equipment available, geographic location etc. The sponsor needs to perform due diligence to make sure that the site meets all the requirements for the successful execution of a clinical trial. Budget of the trialalso needs careful consideration in site selection for clinical trials.
Let’s have a look at some of the best practices that helps in selecting the right site:
- Considering Factors that Impact Site Selection
The first criterion for site selection for clinical trials is to understand the design of the study. Depending on this, you need to choose a geographical location and assess the potential sites that are available there. This must be followed by defining your target patient group which automatically excludes some of the potential sites. For instance, if you are aiming for a study on children, you need to look only for paediatric sites. The next step is to ensure that the preferred site has all the resources to follow the study protocols. It’s a good practice to define all your requirements, based on your trial design, beforehand to make a good decision. The staff available at the site also has a huge impact on the study. Thus, evaluate the motivation and interest of the site staff because if they aren’t willing, the study won’t be conducted properly.
2. Recruiting the Right Patients
Site selection directly impacts the recruitment of right patients for the study. After deciding upon the site, make sure that the staff understands the study protocol and knows the target patient group. The staff needs to understand properly the specific procedures for the clinical trial and the characteristics required for the target group. If the protocol is well understood, the investigators would be able to identify and recruit the right candidates. After identifying the right patients, the next step is to inform and convince them to participate in the trial. This part requires a good relationship of the investigators with the patients which could help the former to convince the latter.
3. Optimizing the Budgetary Considerations
Plan a realistic budget based on the study design. Budget is usually estimated on the basis of study population. For proper site selection and optimizing the budget, it’s important to work closely with investigators as they understand the site and have a relationship with the patients, which in turn helps in estimating a realistic budget. However, sometimes even a well estimated budget could bring in financial constraints because of various factors like delays in study completion or need for more planning or staff, and these could add to more costs. Thus, it’s best to include a ‘contingency plan’ in your budget right from the beginning forbeing realistic and including the possibility of changes.
4. Improving Site Selection through Promotions
There are certain general procedures that you can employ for better site selection for clinical trials. One of them is using advertisements for promoting your trial. You can promote your trial with patients as well as professionals but the content of your advertisement should be different for each group. You can share your study with professionals but with patients you need to know about the ethical issues in your country regarding the same. Social networks could also help you in increasing your resources through promotions. Promotions in local media also work like advertising in a local newspaper in the hospital.
Site selection is a crucial part of clinical trials. Choosing a wrong site not only prevents you from reaching the goal but also leads to higher costs and unnecessary delays. The process of site selection for clinical trials can be improved in various ways but the strategies always depend on the trail design. Working with different people may lead to conflicts of interests among the staff, investigators or other parties. You can employ various technical as well as scientific tools for selecting an ideal site but dealing with people needs to be done in the right manner.