Collaboration is the key to successful clinical research
Monday, April 25, 2016
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
Without collaboration, there is little opportunity for progress in clinical research. From preclinical to postmarketing research, from project assistant to project lead, from CRO to pharmaceutical sponsors, our commonality is our mutual reliance on each other. All work and efforts throughout a study cycle have the impact of a domino effect. Synchronicity ensures productivity, while division results in chaos and detrimental delays. It is our responsibility to work together to protect study patients and produce credible data, two of the most critical elements of drug development.
Teamwork is what makes the difference in reaching important site selection, activation and data analysis milestones, all driven by monitoring visits (pre-study visit, site initiation visit, interim monitoring visit and close-out visit). There is no singular path to success in monitoring visit conduct. The Clinical Research Associate (CRA) and investigational site must collaborate to prepare, conduct and complete a study successfully.
The first collaborative indicator between the CRA and potential investigational site occurs at the pre-study selection visit. Preparation and compromise intersect to confirm the potential for teamwork. The onus is on all participants to ensure that site capability for study conduct is assessed. Investigational staff must not jump through hoops to demonstrate competency while the CRA merely observes. The site must not rest on institutional laurels and refuse to assist the CRA with the expedition of the evaluation process. It requires collaborative effort to determine the desired outcome: is the site is a good fit for the study, is the study a good fit for the site, and will the CRA/site partner successfully?
Tips to stay efficient and on track during study meetings or monitoring visits
- Leave small gaps in complicated agendas to allow for flexibility with changes or difficulty reaching a destination.
- Send a confirmatory email and a confirmation letter to the study coordinator after the visit date is arranged, containing information about specific equipment or facilities (above the norm).
- If touring multiple departments on a large campus, arrange for a member of the investigational staff to accompany you. Ancillary department staff are not always cooperative without a known staff member escorting the monitor.
- Be flexible with schedule changes within the visit timeframe. Be ready to switch to teleconferences or find an alternative solution to data or information collection.
At a recent pre-study selection visit, fraught with small challenges from the onset, the communication and compromise demonstrated was the strongest validation of my decision to recommend the site for the trial.
Due to the availability of the investigator, the pre-study selection visit had been scheduled to start in the afternoon. I was to meet with the Principal Investigator and staff at 1pm, the investigational pharmacy at 2pm and then complete the remainder of the assessment discussion and facilities tour with the study coordinator (SC). The monitoring visit would finish after 5pm. Under normal circumstances this would not be an issue; however, the institution was located in a smaller city/airport. The last flight of the evening left at 4pm, which would force me to fly home the next day, at increased cost and inconvenience to my schedule. With one explanatory email from me, the SC rescheduled all meetings with pharmacy and ancillary personnel for that morning, so that the pre-study visit would finish with the investigator meeting at 1pm. The SCs compromise allowed me to travel home the same evening.
The complicated therapeutic indication/endpoint required that we confirm specific diagnostic equipment operation, calibration and results reporting efficiency (in the hospital) during the pre-study visit to ensure it complied with protocol requirements. In the past, most SCs had only been able to arrange for me to visually inspect the equipment during the hospital tour—not all had been able to ensure key staff were present during the assessment to confirm equipment efficiency and reporting analysis. This forced me to email a list of diagnostic questions to the respective department head (after the pre-study visit was finished) to try and chase down answers, resulting in delays to site selection and activation. This SC had successfully arranged for the department head to demonstrate the specific equipment capabilities and results-reporting during the pre-study visit. I was able to retrieve 100% of the required information instead of leaving empty handed as I had previously done at other evaluation visits.
During that same pre-study assessment visit, there was an unexpected emergency with a study patient. The investigator and SC had to temporarily excuse themselves from the evaluation to attend to the matter. Before he left, the SC provided me with the CVs of the investigators and research staff so that I could glean the required education, research and training information I needed for the site information assessment. The investigator and SC CVs were organized and chronologically relevant with institution and trial experience. I was able to confirm as much information reviewing these documents as I normally did during site dialogue. The SC’s creative alternate approach preserved the momentum of the evaluation process and enabled me to obtain timely site information.
The enthusiasm, professionalism and compromise demonstrated by the investigator and SC made for a swift and assured recommendation of their site for the study. This visit ended successfully because it was approached as a team effort.
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. Currently she works in relationship development/study startup in the CRO industry. Email firstname.lastname@example.org
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