OBJECTIVE: To review ongoing trials relating to COVID-19.
METHODS: A systematic search for clinical trials was conducted in the ClinicalTrials.gov database up to April 12, 2020. A total of 339 trials relating to COVID-19 were analyzed and key information on each trial was recorded.
RESULTS: Most of the trials were being conducted in the United States and completion of most of them was expected by May 2020. They were mostly on drugs and treatment, while a minority were on diagnostic tests. The analysis showed that hydroxychloroquine was investigated in most of the trials. The trials identified were categorized into five classes: a) diagnostic tests; b) therapeutics; c) biologics and vaccines; d) devices and products; and e) others.
CONCLUSION: The trials identified have potential against COVID-19 that can be applied in treatment processes after the necessary investigations and experiments. Additionally, the items identified were organized in a proper way, which can assist in current research activities.
DISCUSSION: Traditional clinical trial designs, validation, and evaluation methodologies used for nonorphan drugs often prove unsuitable for orphan drugs, given the small patient populations, sometimes fewer than 1000 cases. There is an increasing need for accessible therapies and both regulators as well as industry are trying to develop affordable and effective drugs to address this need. Despite several steps that have been taken, the timely development of drugs remains a challenge. One of the reasons behind the long development timeline is the recruitment, retention, and conduct of rare disease trials. To optimize the development timelines of orphan drugs in the EU, it is important to ensure that the safety and efficacy of the product is not compromised. Industry and regulatory agencies must implement innovative trial designs, devise flexible policies, and incorporate real-world data for assessing clinical outcomes.
CONCLUSION: Collaboration among academic institutions, pharmaceutical companies (both small and major), patient groups, and health authorities is crucial in overcoming obstacles related to clinical trials and providing assistance and creative ideas. The ultimate objective of granting rare disease patients timely and affordable access to medications with a positive balance between benefits and risks is to be met.
METHODS: The systematic review protocol was registered on PROSPERO on July 26, 2023 (CRD42023445166). The research articles related to the immunogenicity, efficacy, or safety of malaria or TB vaccines that were published between January 1, 2012, and August 31, 2023, were searched on three databases: Web of Science (WoS), PubMed, and ClinicalTrials.gov.
RESULTS: A total of 2342 articles were obtained, 50 of which met the inclusion criteria. 28 (56%) articles reported on malaria vaccine attributes, while 22 (44%) articles reported on TB vaccines. In both cases, the major challenges in sub-Saharan African clinical trials were immunogenicity and efficacy, rather than safety.
CONCLUSION: Factors such as population characteristics, pathogen genetic diversity, vaccine nature, strategy, and formulation were associated with slow progress of the malaria and TB vaccine candidates in sub-Saharan African clinical trials.