Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Impact of the Covid-19 pandemic on the management and conduct of ongoing clinical trials with medicinal products ***

Dr. Jasmin Rickmeyer (Abschlußjahr: 2020)

Summary
Language: English
In 2020, the worldwide spread of the SARS-2-coronavirus disrupted several aspects of health care around the globe. Aiming on the protection of the public health, governments imposed precautionary measures to reduce the spread of the virus. These measures have the potential to negatively impact the safe conduct of ongoing clinical trials. This raised, practically overnight, various regulatory hurdles for sponsors, CROs and investigators. As a result, several regulatory authorities t published COVID-19 recommendations to assist involved stakeholders by setting out conditions for exceptional strategies and arrangement to ensure a safe management of ongoing trials under COVID-19 from March 2020 onwards.
In this thesis, the impact of the COVID-19 pandemic on the conduct of ongoing and new clinical trials (CT) was analyzed based on a database analysis in clinical trial registries and the comparison of the COVID-19 guidelines issued by the competent authorities (CA) during the first wave of the pandemic and the relaxation of the COVID-19 situation in the European Union in summer 2020.
Database analyses in the European EudraCT and the ClinicalTrials.gov registries were performed to identify and characterize the number of ongoing CTs worldwide, in the EU and USA. Based on a ClincalTrials.gov dataset published by B. Carlisle, further investigations were made to analyze and characterize clinical drug trials that were stopped until September 2020 33. Additionally, the COVID-19 impact on the start of new trials was determined by comparing the number of new trials registered per months before and during the pandemic.
The database analysis identified Spain, Germany, France, Italy and the Netherlands as TOP5 EU countries conducting the highest numbers of ongoing CTs during the pandemic. The national COVID-19 guidelines published in these five EU countries and the other two countries of the DACH region (Austria and Switzerland) were analyzed and compared to the European and the US COVID-19 recommendations with a focus on (a) the type of COVID-19 measures recommended, (b) the different regulatory requirements for their implementation and (c) the history of changes added in the COVID-19 guideline revisions published during the first six months of the COVID-19 health care crises until October 2020.
The results of the database analysis and the comparative analysis of the regulatory requirements and the COVID-19 mitigation measures recommended by the competent authorities in the different regions and countries were analyzed and discussed for their negative and positive short- and long-term impact on the conduct of clinical trials and the clinical development of new drugs in future.
Pages: 96
Annexes: 1, Pages: 2