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The Keys to success in Site Selection

Tuesday, February 17, 2015

The Pulse on Study Conduct by Elizabeth Weeks-Rowe

The keys to successful study conduct at the site level are honesty, integrity and transparency:

  • Honest dialogue between the monitor and investigative site staff regarding study status and site capabilities during all monitoring visit types
  • Integrity in credible data collection, and adherence to GCP guidelines regarding patient safety and data reporting throughout the trial
  • Transparency in identification, communication and resolution of site issues during the trial; issues are rarely one-sided, singular errors.

Site issues usually form as a result of unintentional mistakes by site or monitoring staff. Without honesty and accountability, the end result of the issue often is more significant than the discrepancy that caused the problem. Collaborative efforts between the CRA and site staff are required to resolve the issue. Honesty, integrity and transparency help alleviate problems created or prolonged by inexperience, workload or, in rare cases, deception.

Transparency in the site process at trial inception helps forge the critical alliance between the site and the sponsor/CRO that drives study progress. When sponsor monitors are assessing a new site for a study, there is minimal information available about the site’s history prior to the assessment. CRAs usually have access to site-provided feasibility enrollment, experience and statistical information with which to prepare for the assessment meeting. Site-provided data must be accurate and factual for a meaningful site assessment process, as it gives the first impression of site capability. The feasibility discussion confirms the recruitment and experience information provided by the site and is the basis for study participation. Honesty is presumed, and candor is expected. If the foundation upon which a site relationship is built is exaggerated or false, study progression becomes questionable, and study outcome becomes dismal.

How to provide authentic feasibility paperwork

  • Provide accurate statistics on staff, trial and clinical experience in the required therapeutic indication, or note the intent to hire experienced staff in anticipation of being granted the study
  • Run patient database searches to pre-identify potential patients and include these accurate numbers
  • Note specific enrollment numbers and timelines of prior trials your site has conducted in the indication
  • If the investigator does not have experience in the specific indication, provide data on studies conducted in a similar therapeutic area, with enrollment numbers, to demonstrate awareness and enthusiasm.

There is considerable time and cost involved in scheduling/completing a site assessment visit. The transition of site status from consideration to confirmation relies heavily on the quality of information provided in the feasibility paperwork, and expeditious completion of confidentiality disclosure/investigator commitment paperwork.

Once these are completed, the scheduling process begins. A CRA with experience in the therapeutic indication confirms an assessment date and provides the investigator/staff with the protocol and logistical information about the visit. Both sides then prepare: the CRA organizes all assessment paperwork and presentation materials and books travel; the investigator prepares staff and facilities for inspection. The exchange of authentic information around this process is crucial to its success. Whenever information is fabricated to elicit favor or interest, failure is inevitable. It also can sever a connection that took months to develop.

Recently I conducted a pre-study assessment visit that took place under false pretenses. It was a critical loss of the sponsor’s time and revenue, as the site had exaggerated its feasibility information. Our team was assessing sites for a pivotal dermatology study. The sponsor’s site criteria was very specific—proven experience and success in the therapeutic indication to be considered for trial participation. I was asked to conduct a last-minute visit at a site in the Southwest. The distance and the aggressive deadline resulted in an expensive airfare. The site was stellar on paper; according to feasibility data, it had conducted several successful trials in the indication and the investigator and staff specialized in the disease. The sponsor’s expectation of site performance was the rationale for waiving standard airfare expenses. A successful assessment and quick site activation was expected. I was looking forward to visiting such an experienced site.

When I arrived at the site, I was told the study nurse was running several minutes late. She arrived 20 minutes later and asked if she could copy my presentation materials, as she had forgotten to bring the ones I had sent her. This was atypical behavior for an experienced coordinator. The nurse then told me the investigator was out of town and would not be attending the assessment visit. This was surprising, since this nurse had confirmed the visit date and investigator availability a week earlier. When I inquired, the nurse gave a vague answer about an unexpected schedule change. Despite my doubts, I proceeded with the assessment visit and arranged to call the investigator the following week.

Within minutes of the site experience discussion, I knew we had been provided incorrect data. The nurse’s information conflicted with the feasibility information provided. Specifically, the investigator did not specialize in the disease under study and had conducted only one study in the therapeutic indication, 15 years earlier, and the study nurse had less than one year of research experience. I completed the visit quickly and professionally, though I was extremely disappointed. The sponsor had trusted the site’s data and had spent thousands of dollars in time and resource allocation as a result. For the site, providing false information resulted in insurmountable loss of sponsor trust and future consideration. All of this would have been prevented with honesty, integrity and transparency. 

 

Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She also is author of the novella Clinical Research Trials and Triumphs. Currently she works in relationship development/study startup in the CRO industry. Email ebwcra@yahoo.com

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