Stakeholder | Secondary theme associated with conservatism | Contributors linked to secondary theme |
---|---|---|
Cross-disciplinary | â–ª Unfamiliarity and lack of understanding | Â |
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 |