The recommendations focus on creating a culture and open dialogue around quality, determining what’s essential to ensure participants’ safety and the credibility of study results, involving various stakeholders to participate in the creation of the trial protocol, and identifying and reviewing factors that are critical to quality.
“Discourage overreliance on checklists and inflexible ‘one size fits all’ approaches that undermine creation of specific strategies and actions intended to effectively and efficiently support quality in a given study,” CTTI says.
The initiative, which now includes more than 60 member companies, also encourages sponsors and CROs to streamline trials and consider “whether nonessential activities may be eliminated from the study to simplify conduct, improve trial efficiency, and target resources to most critical areas.”
The recommendations use the example of a cardiovascular major morbidity outcomes trial, noting that “strategies to ensure that the survival status of all trial participants is captured would be critical, but source verifying participants’ temperature readings obtained as a part of vital sign assessments at routine study visits is unlikely to be considered critical to the successful outcome of the study.”
As far as protocol development, CTTI calls on companies to investigate clinical investigators’ and potential trial participants’ insights “into the feasibility of enrolling patients who meet proposed eligibility criteria, whether scheduled study visits and procedures may be overly burdensome and lead to early dropouts, and the general relevance of study endpoints to the targeted patient population. When a study has novel features in elements considered critical to quality (e.g., defining patient populations, procedures, or endpoints), early engagement with regulators should also be considered.”