Disclosing the patient-recruitment targets and performance of all investigators working on a clinical trial (CT) would be a “logical next step” in the drive to improve study transparency, an international group of academics and clinical research professionals has argued.
Adding this information to public registries such as ClinicalTrials.gov would be of value to a range of stakeholders including research ethics committees (RECs), patient organisations, hospital and university managers, clinical trial networks, public or private study sponsors and health authorities, write Rafael Dal-Ré from the Pasqual Maragall Foundation in Barcelona and colleagues from Canada, Denmark, the UK, France and Spain in the latest issue of the open-access journal PloS Medicine.
For example, they suggest, a REC or institutional review board may want to assess the qualifications of a given researcher when reviewing a clinical trial protocol. Sponsors looking to start a trial may prefer to recruit investigators with a track record of fulfilling their commitments, while hospital or university managers could access data on the performance of their investigators in activities that may have an effect on their institution’s prestige.
Patient organisations, for their part, may want to know which investigators actually recruit the most participants to clinical trials in their area of interest, Dal-Ré et al add.
Subgroup analyses
Moreover, since it is “well known” that both ethnic and standard-of-care variations can influence treatment outcomes in different geographical regions, being able to pin down the percentage of study participants coming from different countries “could prompt queries to the sponsor from experts about regional subgroup analyses”, they say.
Recruitment data could also be of interest to researchers conducting meta-analyses, the authors believe, while trial participants have a right to be informed of study results, including circumstances in which a clinical trial is not concluded due to recruitment issues.
Lastly, Dal-Ré et al contend, full transparency on recruitment goals and outcomes should help to reduce the risk of study misconduct and fraud.
Full transparency
This transparency should encompass recruitment targets for all site investigators involved in a trial before it starts, as well as their final recruitment performance and information on issues that may have affected recruitment, the authors say.
Specifically, they would like to see public disclosure of:• Investigator names, contact details and affiliations
• Site recruitment status (e.g., “not yet recruiting”, “completed”)
• Recruitment commitment (i.e., number of participants to be recruited)
• Actual recruitment (number of participants actually randomised)
• Non-investigator-related issues that affect trial recruitment
• Unexpected investigator-related issues that affect trial recruitment.
Some sponsors already provide information on the recruitment status of all sites involved in a multinational clinical trial, Dal-Ré et al acknowledge. On the other hand, data show that in as many as 66-75% of clinical trial reports, there is no sample-size estimation in the study protocol.
Failed contract
Without this kind of transparency, the authors argue, the large number of clinical trials that do not currently recruit to target risk being underpowered or even scientifically obsolete and ethically unacceptable.
