Bitesize Regulatory News 5 Oct 2021
USA FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are…
Continue readingClinical Trials Set Up
Simplifying 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 readingWhat Are the Criteria for Enrolling People with Intellectual Disabilities in Clinical Research?
It is generally accepted that people with intellectual disabilities are not considered in clinical research if the type of the disease could be studied with people without disabilities. The reasons…
Continue readingHow to Select Sub-Investigators in Clinical Trials?
Working on clinical trials requires very high qualified staff and some of the most important resources when working in clinical research are sub-investigators. Sub-investigators are qualified consultants who have relevant…
Continue readingHow Informed are Participants from the Informed Consent Form?
I was travelling in a taxi during the recent months and after I mentioned I work in clinical research the taxi driver decided to share with me that he has…
Continue readingClinical Trials and Medications Adherence
While medications adherence is important topic in medical community it is even more critical in clinical research. Accumulation of missed doses and unplanned dose interruptions in clinical trials could affect…
Continue readingBenefits and Challenges of Health Research Registers
Identifying eligible patients for clinical trials has always been a challenge in clinical research. Although hospitals are already aware of their patient population this does not mean that all their…
Continue readingCommon GCP Audit Findings and How to Avoid Them
Recently I had the pleasure to attend GCP meeting in London, UK where there was a discussion on common audit findings in clinical trials. Some of the issues discussed are…
Continue readingOn Site Clinical Trials Drugs Monitoring
If you are a pharmacist working on clinical trials you are probably well aware of the clinical trials drugs temperature monitoring requirements. If you work only with medications that require…
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