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Table 4 Inductive themes perceived to be linked to conservatism

From: Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials

Stakeholder

Secondary theme associated with conservatism

Contributors linked to secondary theme

Cross-disciplinary

â–ª Unfamiliarity and lack of understanding

 

â–ª Fear of introducing operational bias during conduct and compromising the trial

â–ª Concern about the robustness of ADs in decision-making

â–ª Fear of making wrong decisions

â–ª Concerns about premature early stopping of trials

â–ª Concern that the research community may struggle or be reluctant to accept the findings from an adaptive trial

â–ª Contrived general perception by journal editors and reviewers that early trial stopping is a failure

â–ª Impact of early trial stopping on other secondary but important objectives

â–ª Research teams being more comfortable with traditional fixed designs than ADs

â–ª Sticking to what we know best and fear of venturing into the unknown

â–ª Lack of knowledge and experience

â–ª Generation effect - more senior trialists being sceptical of change from what they know best and perceive as standard

â–ª Perceived operational and statistical complexities during planning and implementation

Regulators

â–ª Buy in reluctance in confirmatory setting

â–ª Lack of understanding of the inferential and regulatory price to pay by using an AD

â–ª Fear of lowering the level of evidence

â–ª Fear of making wrong decisions that may taint their reputation in the future (for instance, approving a drug that will subsequently be proved to be unsafe or ineffective)

â–ª Limited experiences in the assessment and approval of ADs

Statisticians

â–ª Negative attitude towards ADs among some influential statistical community

â–ª Generation effect - more senior researchers being sceptical of change from what they know best and perceive as standard

Private and public funders

â–ª Reluctant to fund potential high risk high value research projects with huge uncertainty

â–ª Uncertainty around the actual sample size, duration and actual cost of the trial

â–ª Inadequate description of variable costs, decision-making criteria and time frames on grant applications (public funders)

â–ª Limited commissioning and funding experiences, especially among public funders

â–ª Difficulties in drawing up flexible employment contracts (public funders)

â–ª Limited number of AD grant proposals being submitted by researchers for consideration (public funders)

â–ª Negative attitudes towards ADs among some public funding panel members

â–ª Lack of familiarity

IDMC and TSC members

â–ª Perceived negative attitudes towards multiple examinations of the trial data

â–ª Lack of familiarity and understanding

â–ª Reluctant to stop trials early unless for safety reasons