Innovative Clinical Trial Designs: Overview
Those who have worked on clinical trials for many years probably remember the rigidity of the clinical protocols and how often clinicians complained that the study design is out of…
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Is Clinical Trial Design Fit for Purpose?
It is not a secret that the research and development in the pharmaceutical industry is very costly, time-consuming, risky and not particularly efficient. According to estimates bringing new drugs on…
Continue readingCAR T Cells and the future of HIV therapy
Chimeric antigen receptor (CAR) T cells have been studied for over 25 years and are very successful in some types of cancer. With more than 30 million people living with…
Continue readingClinical Trial Design and Patients with Brain Metastases from Solid Tumours
The most common spread of metastatic solid tumours in central nerve system (CNS) is as parenchymal brain metastases or as leptomeningeal disease (metastases in brain membrane or spinal cord). Because…
Continue readingFDA Legislation Changes: July 2018 FDA Extends Access to Experimental Drugs
FDA extended access program started back in 2009 and it allowed patients with life-threatening diseases who have exhausted all other options to try experimental drugs, which are not on the…
Continue readingPaediatrics Clinical Trials: Children Are Not Simply Small Adults
Children often have the same diseases as adults, however many of the approved drugs on the market are not tasted in children. Many rare and serious diseases affecting children have…
Continue readingCancer Immunotherapy and Killer Cells
Cancer immunotherapy is a promising field in drug development because it provides new treatment options for various cancers, especially in combination with standard of care. Immune system can recognize and…
Continue readingSimplifying Oncology Informed Consent in Clinical Trials
Current expectations are that by 2030 the annual new cancer cases will reach 22.2 million people. There is an urgent need of new more efficient therapies to tackle raising cancer…
Continue readingClinical Trials and Restricted Medications
During my recent work I came across 2 cases of usage of restricted medications in patients participating in clinical trials. In both cases restricted medications were prescribed by GP or…
Continue readingClinical Trials in Rare Diseases Have Their Rare Problems
Before we can start discussing the issues with conducting clinical trials in rare diseases we can clarify what type of conditions will classify as rare diseases. Often rare diseases include…
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