Commentary on the Booksellers' Bill (1737)

This Bill marks the first occasion on which the British legislature proposed to confer upon authors a lifetime interest in their literary works (with an additional eleven year post-mortem term vesting in their estates), as well as limited rights of translation and abridgement. In addition the draft legislation proposed to render null and void any contract purporting to assign an author's rights to another for a period of longer than ten years.
The commentary describes the background to the Bill, and in particular the attempts of the London book trade to secure more extensive legislative protection in both 1735 and 1737. It argues that the 1737 Bill is significant precisely because it was never made into law, and because it did not suit the best interests of the metropolitan booksellers. Instead, the book trade increasingly turned to the courts to further secure their commercial interests, giving rise to what is commonly referred to as the ‘battle of the booksellers' throughout the next 40 years.

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.

Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.

Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).