Applications of Clinical Trials & Site Monitoring
When pharmaceutical companies want to develop a new drug for a particular ailment, they must conduct clinical trials. The company first develops the lead compound through the drug discovery process. Clinical trials involve research on the chemical and biological composition of the new drug, which the drug regulatory authorities must approve.
The clinical phase involves volunteers. First, the new drug is tested on healthy people to ascertain its safety. If there are no side effects, the drug is tested on volunteers suffering from the targeted ailment. After the drug passes all the initial regulatory approvals, it goes through the final approval stages, registration, and valuation.
A good example is the development of the COVID-19 vaccine.
The medical field has advanced over the years with new inventions and discoveries. Medical research focuses mainly on incurable diseases and their behavioral patterns. Researchers seek to better understand available treatments of these ailments to improve the administration. The clinical trial is an integral part of the process as it collects data for research.
Researchers rely on previous studies and try to improve their processes. They develop the lead compound and use clinical trials to monitor its behaviors on participants. If the lead compound improves the outcome compared to the previous study, researchers archive the data for future reference. Most terminal disease researchers use this methodology to develop a preventive treatment, a curative drug, or a medicine that reduces its prevalence. HIV/AIDS and cancer are good examples of medical research ailments.
Emerging trends in pharmaceutical regulations require drug regulation authorities to update their guides in managing inventions and innovations constantly. Technology in the medical field improves every day. Clinical trials are avenues used to gauge advancement in the medical field and explain how these discoveries can improve the sector.
Medical researchers follow science to come up with a recommendation. Any improvement in drug development denotes progress in drug manufacturing. However, such processes may be problematic. The process could cause side effects or it could conflict with ethical beliefs. Regulation authorities employ both science and ethical standards to approve or reject a clinical trial. This prompts medical researchers to change approaches to improve its efficacy level and have the least effect on ethical and social standards in society.
Considerations When Undertaking Clinical Trials
Coming up with a new medical intervention requires in-depth scrutiny since its usage has a lot at stake. Before its application, the regulator and research institution should consider the following:
Special interventions within a larger group - Research in the medical field should address special groups inside the larger drug market. As much as the intervention seeks to address a specific medical issue, special people within that larger pool need specialized intervention as well.
Complex protocols - The clinical trials should have a precise sample size that will demonstrate a statistical result of the study. There should also be clear instructions for how participants use the drug (e.g., the required dosage and administration.
Risks - When developing a new intervention, one should consider the observed risks from the available intervention methods. This helps control the outcome of the trials and increases the success rate.
Sponsorship - The type of partners enjoined in the study could help accelerate the clinical trials.
Distribution and site monitoring - The supply chain is a complex web that combines logistics, storage, temperature monitoring, and clinical trials. The clinical trials should understand the end-to-end distribution because it directly affects the viability of the project. If the intervention development and administration happen in separate regions, factors like temperature change should take center stage as it affects the quality of the intervention.
A partner like ELPRO can support Sponsors, Managers, and Supply Chain Professionals of Clinical Trials to simplify the clinical supply chain of temperature sensitive IMPs. The right temperature monitoring solution for transport and storage will not only protect patient safety but also increase and simplify patient recruitment.