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The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to…
Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…
Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…
In April this year, the World Health Organisation (WHO) issued a statement on the public disclosure of clinical trial results (the full statement is available from http://www.who.int/ictrp/results/reporting/en/). In essence, this statement…
‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…
Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…
Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights…
Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of…
Ovarian cancer is a really nasty disease. Although, like most cancers, it is curable if caught early enough, in practice it is not usually diagnosed until it is too late for curative treatment. It initially responds well to treatment and patients…
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