Future good scientific publishing practice will necessitate wider data transparency

Dear Editor,

The increasing efforts to ensure transparency and completeness in the reporting of clinical trial results necessitate a concerted drive to ensure appropriate knowledge training for all those involved in publications using trial data.

A number of guidelines to promote ethical and good publication practices have been steadily introduced and adopted by most peer-reviewed journals1–3. Nevertheless, reports about shortcoming with respect to data transparency, publication bias and selective reporting bias continue to emerge4,5. It should be noted that these issues are increasingly being covered in the mainstream media and that this affects negatively the public’s trust in scientific literature and those who are involved in medical communication6–9.

As a consequence, a number of independent scientists seeking increased data transparency have been calling for public access to clinical study reports and other documents containing unpublished trial data6–9. Incomplete information or the selective reporting of data can lead to erroneous conclusions being made about results, which may harm patients and lead to needless expenses for the healthcare system9. Furthermore, there is an argument from researchers that reliance on such potentially incomplete information in biomedical journals does not allow them to draw valid conclusions10,11. They also cite ethical reasons for public access, arguing that one reason for patients’ willingness to volunteer for clinical trials is the contribution to medical knowledge and that a failure to publish trial results undermines the trust being placed in trial sponsors10,11.

Importantly, in April 2012, these concerns prompted a personal response by reviewers from the European Medicines Agency (EMA)12. In the past, the Agency has held back when challenged to provide public access to study reports and other unpublished sources of data citing concerns over data privacy and protection of commercial interests8. However, the European Ombudsman – an independent and impartial body that holds the EU administration to account – has rejected such reasoning and has ruled that the Agency must be more accountable8. As part of its current overall management strategy the EMA is committed to providing greater clarity and openness in all areas of its operations and consequently has stated that the current situation concerning regulatory clinical trial data is neither “desirable nor realistic”12,13.

While not being in favour of uncontrolled, mass release of data, the EMA reviewers put forward recommendations on three key aspects to improve transparency – rules for sharing of raw data, standards for protection of personal data in case of data sharing, and quality standards for meta-analyses and confirmatory analyses. These recommendations should be considered as a major development to be taken into account by those involved in medical communication12. The EMA reviewers are inviting feedback on their proposals, and this is an opportunity for all stakeholders in medical communication to assist in developing a constructive way forward12. The process of exploring the practical issues concerned will be initiated at a workshop on clinical trial data and transparency to be held at the EMA’s offices on 22 November 2012. The Agency has called for expressions of interest to attend this workshop and is seeking broad stakeholder participation, including representations from industry, academia, patient groups, medical editors and journalists14.

In our experience of providing support and training, many people are not sufficiently aware of the range of guidelines applying to medical communication and are under the mistaken impression that they serve only as an informal “checklist” of items to consider for the preparation of a manuscript or other type of publication. In light of the recent European regulatory developments, any gaps in knowledge must be addressed as a matter of urgency and, consequently, formal renewal of medical education training at regular intervals should be part of this process.

New guidelines and recommendations that emerge from initiatives such as the EMA’s workshop on clinical trial data and transparency will have an impact on authors and medical writers, as the scope of their work will expand. For example, authors and medical writers will need to prepare additional tables with more extensive information that might be posted as supplementary online materials in order to make the requested broader information accessible without affecting word count or readability of the main manuscript. Accordingly, additional budget and resource allocations for publication projects should be anticipated. Furthermore, authors and medical writers may need additional time for a more in-depth review of the study report and underlying statistical reports if all data have to go public. In this regard, the sponsors’ duty to ensure that authors and medical writers have access to full data as outlined in the Good Publication Practice (GPP2) guidelines should be re-emphasised1.

Future demands regarding data transparency are likely to be far more stringent than at present and the data are increasingly being used by bodies such as health technology assessment agencies in their decision making15. A failure to comply with publication rules may prevent sponsors from publishing and disseminating their trial results, however positive and ground-breaking they may be, and might hinder the product’s ability to gain reimbursement upon launch. Accordingly, the commercial impact of non-compliance with publication guidelines has the potential to be extremely damaging and would represent a considerable waste of resources spent for the design and conduct of a clinical trial.

Rather than being feared, the new developments should be welcomed since a lack of transparency only serves to undermine the efforts to develop new medicines. This view is evidenced by the support that the EMA’s recent statements have received from the editors of Nature Biotechnology16 and the European Federation of Pharmaceutical Industry Associations17. Clinical trials are collaborative projects, which can only succeed through joint efforts of sponsors, physicians and patients. Fostering a supportive research publication culture will enable the field of clinical trials to be strengthened overall.

Transparency

This is the original research of the authors and there are no financial and other relationships of a declarable nature for this manuscript.