The Health Research Authority has outlined what it will do to ensure the results of clinical trials are published. Clinical trials includes trials of medicines, devices, surgery, other therapies or diagnostic tools. The plan builds on a discussion that HRA held with stakeholders in April 2013, and on discussions that have taken place at the ABPI and with research funders, where participants have discussed the issues of transparency and the need for the results of all research to be made available when the study is complete.
What have the HRA said?
All trials must gain approval from Research Ethics Committees before they can go ahead. The HRA have agreed that they will make registration of clinical trials within an agreed time frame a condition of REC approval from September 2013. This will affect all trials of drugs, devices, therapies and diagnostics taking place in the NHS. They will work with research funders and sponsors to set standards for the publication and dissemination of research outcomes, dependent on the type of research. The detailed data from clinical trials are also valuable for conducting further analyses. This must be handled very carefully to ensure no identifiable information is accessed by researchers. However there is a concern that the data collected by some research studies cannot be re-used by researchers in this way because the original consent form signed by the patient explicitly excluded data sharing. The HRA are planning to include advice and recommended text in consent forms in future to ensure that consent is in place at the outset, avoiding any barriers to future data sharing and access to tissue. HRA have also agreed to work with others on overcoming other barriers to transparency including:
- Tackling unhelpful perceptions that negative findings are not valuable
- Encouraging greater awareness of online journals where these findings can be published
- Clarifying how early release of data sits with later peer reviewed publication, and agreeing sensible frameworks with publishers to dispel fears that early release will prevent publication
Why is this important?
Patients choose to take part in research because they hope that the treatment will benefit them, and because they want to improve treatment for others in the future. To ensure this can happen, we believe trials must be registered and the findings of research made available for others to learn from. It is in the interest of everyone that research is published once it is complete. Funders demand it as part of their terms and conditions of awards, and regulators expect it as part of granting the approval to carry out the work. But many fear that some research is not published, and that this lack of transparency will lead to a hole in our knowledge with potential impact on safety or causing unnecessary duplication.
What will happen next?
HRA have identified some areas of transparency where more work is needed. They will be looking at how to ensure that researchers adhere to their plans for tissues and data that arise from research to be made available for research. They will also be working with the patients to determine the best ways for the results of research to be presented back to participants.