Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials.

BACKGROUND: A 2003 survey suggested the number of noncommercial trials in the UK was declining. Formation of the NIHR in 2006 and increased research spending by the Department of Health may have increased the number of noncommercial trials but no data are available. METHODS: Available data on UK noncommercial trials (were obtained from the two relevant registries: ISRCTN register for the UK, and US ClinicalTrials.gov. Data on each trial were sorted by start year, and compared with the: 2003 survey, and UKCRN portfolio database from 2007. RESULTS: The number of UK noncommercial trials registered rose from 25 in 1990 to 188 in 1999, peaked at 533 in 2003, and fell back to 334 in 2009. Total trials registered was similar to but slightly above those in the 2003 survey up to 1998, then rose sharply to 2002 before falling to 2007. From 2007 to 2009 the number registered to start each year was similar to but slightly above the UKCRN database. Less than 10% of UK noncommercial trials registered with ClinGov for most years before 2005, but this rose to 35% by 2009. CONCLUSIONS: For the periods of overlap, trial registration data provide fairly similar totals to other sources on the number of noncommercial trials starting each year. The rise and fall in the number of trials registered between 1999 and 2007 was due to those registered in the ISRCTN database as funded by NHS Trusts. After 2007, the number of trials registered as funded by NHS Trusts has fallen in the ISRCTN register but these trials may have migrated to the US ClinGov register. The total number of noncommercial trial starts, excluding those funded by NHS Trusts, has been upward since around 2002. By 2009 the two main funders were NIHR and charities. Feasibility of using registration data to monitor the number of noncommercial trials has been demonstrated but is complicated by the use of two registers and difficulties in accessing the data. We recommend an annual report on the number of noncommercial trials registering each year.

The CHD challenge: comparing four cost-effectiveness models.

OBJECTIVES: To compare four UK models evaluating the cost-effectiveness of interventions in coronary heart disease (CHD), exploring the relative importance of structure and inputs in accounting for differences, and the scope for consensus on structure and data. METHODS: We compared published cost-effectiveness results (incremental cost, quality-adjusted life year, and cost-effectiveness ratio) of three models conforming to the National Institute for Health and Clinical Excellence guidelines dealing with three interventions (statins, percutaneous coronary intervention, and clopidogrel) with a model developed in Southampton. Comparisons were made using three separate stages: 1) comparison of published results; 2) comparison of the results using the same data inputs wherever possible; and 3) an in-depth exploration of reasons for differences and the potential for consensus. RESULTS: Although published results differed by up to 73% (for statins), standardization of inputs (stage 2) narrowed these gaps. Greater understanding of the reasons for differences was achieved, but a consensus on preferred values for all data inputs was not reached. CONCLUSIONS: We found that published guidance on methods was important to reduce variation in important model inputs. Although the comparison of models did not lead to consensus for all model inputs, it provided a better understanding of the reasons for these differences, and enhanced the transparency and credibility of all models. Similar comparisons would be aided by fuller publication of models, perhaps through detailed web appendices.