Table 4.
Inductive themes perceived to be linked to conservatism
| Stakeholder | Secondary theme associated with conservatism | Contributors linked to secondary theme |
|---|---|---|
| Cross-disciplinary | ▪ Unfamiliarity and lack of understanding | |
| ▪ Fear of introducing operational bias during conduct and compromising the trial | ||
| ▪ Concern about the robustness of ADs in decision-making | ▪ Fear of making wrong decisions | |
| ▪ Concerns about premature early stopping of trials | ||
| ▪ Concern that the research community may struggle or be reluctant to accept the findings from an adaptive trial | ||
| ▪ Contrived general perception by journal editors and reviewers that early trial stopping is a failure | ||
| ▪ Impact of early trial stopping on other secondary but important objectives | ||
| ▪ Research teams being more comfortable with traditional fixed designs than ADs | ▪ Sticking to what we know best and fear of venturing into the unknown | |
| ▪ Lack of knowledge and experience | ||
| ▪ Generation effect - more senior trialists being sceptical of change from what they know best and perceive as standard | ||
| ▪ Perceived operational and statistical complexities during planning and implementation | ||
| Regulators | ▪ Buy in reluctance in confirmatory setting | ▪ Lack of understanding of the inferential and regulatory price to pay by using an AD |
| ▪ Fear of lowering the level of evidence | ||
| ▪ 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) | ||
| ▪ Limited experiences in the assessment and approval of ADs | ||
| Statisticians | ▪ Negative attitude towards ADs among some influential statistical community | ▪ Generation effect - more senior researchers being sceptical of change from what they know best and perceive as standard |
| Private and public funders | ▪ Reluctant to fund potential high risk high value research projects with huge uncertainty | ▪ Uncertainty around the actual sample size, duration and actual cost of the trial |
| ▪ Inadequate description of variable costs, decision-making criteria and time frames on grant applications (public funders) | ||
| ▪ Limited commissioning and funding experiences, especially among public funders | ||
| ▪ Difficulties in drawing up flexible employment contracts (public funders) | ||
| ▪ Limited number of AD grant proposals being submitted by researchers for consideration (public funders) | ||
| ▪ Negative attitudes towards ADs among some public funding panel members | ▪ Lack of familiarity | |
| IDMC and TSC members | ▪ Perceived negative attitudes towards multiple examinations of the trial data | ▪ Lack of familiarity and understanding |
| ▪ Reluctant to stop trials early unless for safety reasons |