The ORINOCO study, a comprehensive analysis of data collection efforts in clinical trials, has revealed a significant imbalance in the allocation of time and resources between primary and secondary outcomes. The study found that trial teams generally spend three times more time collecting data for secondary outcomes than for primary outcomes, raising questions about the efficiency and focus of current trial practices.
Data Collection Time Disparity
The research team analyzed 161 trials, including 120 phase III trials, 21 core outcome set trials, and 20 public health trials. Data collection times were meticulously gathered from trial reports, direct communication with trial teams, and experienced professionals. The median time spent on primary outcomes was 56.1 hours, while a staggering 190.7 hours was dedicated to secondary outcomes. This translates to a median primary to secondary data collection time ratio of 1.0:3.0.
"The substantial difference in time allocation between primary and secondary outcomes suggests that trial teams may not be fully optimizing their data collection efforts," said a lead researcher on the ORINOCO study. "It's crucial to ensure that the time invested in collecting data aligns with the importance of the outcome to the trial's objectives."
Cost Implications
The study also assessed the notional data collection costs, estimating an overall median cost of £8,015.73 per trial. Costs varied widely, ranging from £52.90 to £31,899,140.70, with public health trials exhibiting the highest median data collection costs at £20,043.45. These figures underscore the significant financial implications of inefficient data collection practices.
Trial Type Variations
While the imbalance between primary and secondary outcome data collection was observed across all trial types, some variations were noted. Phase III trials had a median primary to secondary ratio of 1.0:3.1, core outcome set trials had a ratio of 1.0:3.4, and public health trials had a ratio of 1.0:2.2. Public health trials, however, demonstrated a greater focus on primary outcomes compared to other trial types, albeit with higher overall data collection times and costs.
Implications for Trial Design
The ORINOCO study highlights the need for trial teams to carefully consider the work involved in collecting data for selected outcomes. This includes evaluating the relative importance of each outcome, seeking input from intended users of the trial results (such as patients and healthcare professionals), and aligning the trial budget with the data collection workload. The use of core outcome sets, which are developed using formal methods of patient and stakeholder involvement, can help ensure that selected outcomes are relevant and important.
Addressing Data Collection Challenges
The study also acknowledges the challenges associated with obtaining accurate data collection times. Many trial teams struggled to provide this information, suggesting that data collection workload is not routinely monitored or reported. The researchers recommend that trial teams start tracking and reporting data collection times to facilitate better planning and resource allocation.
The ORINOCO study provides valuable insights into the distribution of data collection efforts in clinical trials. By highlighting the imbalance between primary and secondary outcomes, the study encourages trial teams to optimize their data collection practices, improve efficiency, and ensure that resources are allocated effectively to achieve trial objectives.
