Clinical trials are often under way before the site and sponsor truly have the information necessary to ensure the study will be productive downstream. There is a great need to improve how things are done upfront during feasibility to ensure success during activation and beyond. Here are a few ways sponsors can improve the feasibility process and get the best possible information from sites.
Explain the goal of the questionnaire to the site
Sponsors need to be clear about what they hope to ascertain when they send out feasibility questionnaires.
- If the protocol is in development, are you seeking information that would help answer critical questions about the study design or eligibility criteria?
- Are you simply looking to assess the site’s interest and enrollment potential?
- Are you trying to obtain some operational information related to the site’s infrastructure?
- Or, is it some combination of the above?
Depending on the goals of the sponsor and the timing of protocol development and site selection process, needs and priorities may vary. However, the more the site knows, the more intelligently they can think about the information to determine if they can fulfill your goals.
Give the site enough time to put together thoughtful answers
It’s common for feasibility questionnaires to be sent to sites with the requirement to be completed within 48-72 hours (though as little as four hours has been reported). To help drive a successful protocol design or site selection decision, sponsors need to be more proactive in giving sites the time they need to get the best possible answers. If you ask sites for the world in only a couple days, they will not have enough time to prepare in a way that will truly help anyone in the long run. Rather than trying to get through the initial phase as quickly as possible, focus on preparation and planning.
Make simple changes to your traditional feasibility questionnaire
It’s no secret sites find the current format of most feasibility questionnaires very difficult. To make the process easier:
- Don’t have all fields marked as required. Allow sites to skip around questions if it’s an electronic questionnaire.
- Allow comments and free text spaces. Give sites a way to complete the survey with additional information. While you may think you’re doing sites a favor by creating simple electronic forms, limiting the type of information sites can share may potentially lead to incorrect data. Allow sites to elaborate on information, as it may not be easily answered by using a single number in the data entry field.
- Don’t assume there’s only one PI at a site. Take into account that there could be a large group with multiple sites and/or PIs.
- Don’t send out a survey that can’t be printed. Many sites want to review the questions before answering them.
- Provide contact information. Include email and/or phone on the questionnaire for someone who can answer questions about the protocol. Questionnaires need to capture the correct data, and to do so, sponsors must make it possible for sites to provide the right information.
Don’t start from scratch each time
Sponsors recognize they need to stop reinventing the wheel each time they do trial feasibility. To do this, use data collected from sites from prior projects and track site capabilities in a database to eliminate the need for sites to complete redundant information over and over again when being considered for a trial. This includes years of experience, type of studies conducted, infrastructure (staffing, facilities, equipment), etc. In turn, this enables sites to use the time they spend during the feasibility stages for more value-added activities, like conducting more robust enrollment validation efforts truly driving study success.
Identify the right point person from your organization that can answer sites’ questions.
Don’t replace all human contact with a survey. There needs to be a mix of automation and human communication. If sites have questions about feasibility, who can they talk to? Contact information should be available on the questionnaire, however, sites often find the contact listed doesn’t have the ability to answer questions. It would be best if the point of contact is the person responsible for the feasibility, and they should be available to answer questions.
Additionally, the CRO needs to be able to answer all questions, as sites become frustrated when the CRO isn’t knowledgeable about the protocol. Simple answers may seem more efficient, but sometimes it helps to have a conversation to help clarify or provide additional information. If you do not have a single person who can answer the majority of questions, provide a mechanism or point person who can get the right answers. A personal relationship will build a lot of trust with a site. The better and faster you can support the site in getting the information they need, the better and faster you can plan for your trial.
Follow up with every site that submits a feasibility questionnaire
After the initial feasibility assessment process occurs, many weeks or months may pass from the time the site provided the initial responses to when the sponsor finalizes the protocol and establishes the study budget. In many cases there is no systematic follow-up by either party to assess the status, timeline or result of the feasibility assessment. If you need additional information from a site, follow up with them. The majority of times, sites not selected never hear back from the sponsor or CRO and have no idea why they weren’t chosen.
- Did they not have enough potential patients?
- Did they not have enough experience?
- Did they not have adequate facilities and staffing?
- Or, were there protocol, investigational product or other issues that impacted the decision and had nothing to do with the site?
The absence of such information and lack of transparency and closure leaves the site wondering why they invested all that time and effort to submit the questionnaires and also prevents them from applying any learnings to the next study opportunity.