Overcoming confidential information challenges faced by study sponsors today - Volume 32, Issue

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…

Medical writing for cancer trials and submissions - Volume 21, Issue

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…

Good clinical practice (GCP): A universal call for ethics in biomedical research - Volume 23, Issue

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…

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

Immuno-oncology: Harnessing our immune system to fight cancer - Volume 27, Issue

The history of immunotherapy to treat cancer began in 1891 when the American surgeon William Coley performed intra-tumoural injections with inactivated bacteria in patients with advanced sarcoma, in an attempt to stimulate anti-tumour immunity.…

Clinical trial disclosure and transparency - Volume 27, Issue

The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…

Post-approval regulatory writing - Volume 23, Issue

Medical writing in paediatrics: Children and the future - Volume 21, Issue

‘Children are one-third of our population and all of our future.’ Select Panel for the Promotion of Child Health, 1981 With the falling birth rate I wonder if they still are a third of the population, but there is no doubt that they are our…

Special section: Winners of the Geoff Hall Scholarship essay competition - Volume 24, Issue

The Geoff Hall Scholarships (GHSs) are given in honour of a former President of EMWA. Geoff was a very special person, an extremely valued member of EMWA, and a very good friend to many EMWA members. He firmly believed that the future of EMWA lies in…

Good pharma - Volume 22, Issue

Drugs companies publish only a fraction of their results and keep much of the information to themselves. Drug companies are ‘debasing’ drug trials whose publication in journals can apparently confer scientific approval. Merck had fought for years to …