The art of conducting Feasibility Study: putting the puzzle together

Prior to the initiation of any clinical trial and making strategic decisions regarding what countries and which sites are suitable for the particular area and population of research, a thorough investigation of the situation on grounds is required. 
 
This choice can make the difference between the success or the disappointment from the research endeavor. Country feasibility is particularly important, as countries vary greatly in regulatory restrictions and timelines, and sites can vary greatly in their resources and capabilities to deliver.
 
The relatively small investment and effort can yield significant information early on, saving huge costs.  Avoiding non solid assumptions and surprises in the midst of a trial could yield a smoothly run, well conducted trial.
 
Over the years, Q-trials performed numerous country and site feasibilities in a wide variety of indications and has developed a systematic approach to performing this task.

Here are some tips to the conduct effective  feasibly studies:
 
  • Designated Person. Designate a person, preferably familiar with the indication and with potential sites for the task. Prior experience conducting such tasks is an advantage to the allocated person.
     
  • Set of Tools. Make sure you have everything you need to kick off the feasibility task: confidentiality agreement template, protocol synopsis (at minimum), feasibility questionnaire, list of sites or investigators favored by the sponsor.  At times, a Sponsor might not have acquaintance with the investigators in the country, so this requires your input on who to approach.
     
  • Timelines Planning. Timelines are usually aggressive in feasibility studies and need to be strictly respected.  This can place limitations on the number of investigator sites contacted, or on the choice of specific personnel that can be reached (i.e. not someone currently out of the country) so pre-planning and quick adjustments are key.
     
  • Self Knowledge. Review study protocol as well as Sponsor specifications and questionnaire thoroughly.  Also Sponsor or Q-trials SOPs on feasibility conduct should be checked prior to any action taken. Questionnaire may to some extent be adapted according to local requirements and regulations.
     
  • Risk Anticipation. Try to see beyond the scope of the questionnaire and, based on the protocol requirements, investigate additional questions if you identify unanticipated risks that could evolve.
     
  • Local Regulatory & Site Familiarity. Knowledge of local regulations and the specifics of the local sites are paramount. Discuss with the sites any specific and/or known barriers potentially imposed by the study requirements.
     
  • Investigators Database. maintain a list of key opinion leaders in the various specialties in order to facilitate fast information gathering. Seek additional information as you approach and interview other investigators to widen that list.
     
  • Follow up Spreadsheet. Create a study feasibility spreadsheet and insert the dates of contact, follow ups and follow up information for each investigator site. Include comments where relevant.
     
  • Confidentiality. Agreement (CDA) must be in place prior to disclosure of any confidential information. Make sure you receive fully signed agreement by the approached site(s)’ investigators on the pre-prepared confidentiality agreement. Any holding of such signatures or doubts on authorization to sign may pose delays and additional burden, therefore consider abandoning sites that don’t respond quickly and be prepared to pick others instead.
     
  • Questionnaire Completion. Send out the feasibility questionnaire along with synopsis immediately following receipt of the executed CDA without delay stating timeline expectations. Follow up on receiving it back as completed and as soon as possible.  Review returned documents and make sure you understand what is written. Get back to the site with questions or missing information without delay and before forwarding results to Sponsor.
     
  • Meetings. Where a meeting needs to take place, meet the investigator and any other relevant site staff such as study coordinator. Interview them according to the questionnaire. Ask for a tour of the facilities and a view of their electronic systems and data bases. Collect any wet-ink documents such as CDA and CV where possible and relevant.
     
  • Asses Recruitment. Potential recruitment assessment is particularly important, however it is useful to note that the numbers are sometimes over exaggerated and it is better to have a more conservative approach. Discuss this with the investigator sites. Try to reach not only the investigator him/herself but also other staff members such as study nurse/coordinator. Ask if they can truly stand behind the numbers and deliver. It's important to consider whether the presence of the suitable patient population also means relevant access to the population for the clinical trial.
     
  • Environment Review. Ask about competing studies, the stage of these studies, differences in study population requirements, payments received for the competing studies or other incentives.
     
  • Budget Assessment. Know the costs in advance by clarifying ahead with the sponsor. This issue almost always comes up during preliminary discussions. Countries and sites might differ in cost requirements per study or per patient. In addition, sites could have different approval timelines and contractual requirements. Be as specific as you can about these topics and eliminate sites that are far off the Sponsor scale n this respect. Avoid negotiations at this point and merely convey the information on budget. Ask for reasoning to higher than offered costs and present this to the Sponsor. There might be room for negotiation from the Sponsor's as well site side.
     
  • Results Submission. send back to Sponsor a neat package containing signed CDAs, completed questionnaires, filled out spreadsheets and any comments you may have before or by the stated deadline. Accompany with an email detailing all included items attached and any special comments you would like to highlight. Copy in everyone that was on the original request for feasibility, preferably chaining your response to the original email.
Pairing up with a knowledgeable and experienced CRO will help you navigate the maze of the country and site feasibility, effectively and accurately.  We are available to discuss further on how we can help you achieve your goals.


Dr. Ornit Yanai-Kohelet
Q-Trials CEO

 
 
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