The rapid growth of Clinical trial for Covid 19
Clinical trials have always been proven a boon for good human health. For several years it has been conducted according to the standard procedures but COVID-19 acted as a catalyst and induced changes in clinical trials.
There were hundreds of trials prior to the pandemic which came to hold while many new trials have been launched. Among the new clinical trials, most of the trials are for the effective treatment and interventions against COVID-19 for which the medical personals and pharmaceutical companies are innovating and adapting full-fledged fast-track clinical studies.
Challenges faced by clinical trials due to COVID-19:
- Covid-19 medications and vaccines need fast tracking evaluation and approvals which increased pressure on clinical trials and also affects the trial management and supply.
- The need for social distancing leads to travel difficulties and decreased patient contact while encouraging at-home testing and remote participant monitoring. But this does not reduce the logistic challenges which the clinicians need to overcome with the help of trial suppliers.
- COVID-19 has forced many of the trials to be conducted virtually or remotely with the help of virtual tools leading to an elevating decentralized trial structure requiring thorough logistic management.
- The pandemic has led to travel restrictions and supply shortages that forced the trial suppliers to adopt alternative solutions to ensure the availability of the stocks to meet trial demands.
- Sometimes to fasten up the vaccine development process, certain trial stages are conducted in parallel. Such as early increase in manufacturing prior to the establishment of clinical proof of the concept.
During the pandemic there was an urgent need for effective treatment, so finding vaccine induced global cooperation for research and distribution and in turn, it renewed the focus of the clinical trial industry to move faster. Also, in an effort to tackle challenges, pharmaceutical companies are adopting alternative business models that look for collaborations with research centers and universities in order to fasten up vaccine and treatment development.
Some of the trials repurposed drugs to fasten up the treatment development. Other studies learned from pre-existing knowledge of SARS and MERS and used the vaccines originally developed for them to use against COVID-19. In addition, pre-existing biotechnological techniques are seen to speed up the trials, like the oxford vaccine developed being in partnership with Astra Zeneca utilizes viral vector technology which was originally developed for the MERS vaccine.
Other studies tried to find out the potentiality of targeted monoclonal antibodies designed to enhance patient immunity against the virus and the method to lower the virus’s effect.
COVID-19 has disturbed the standard trial procedures but the clinical trial managers have also managed to continue the trials through innovations and expert logistic handling. The following are the important approaches taken during COVID-19 for successful clinical outcomes:
- Increasing the use of “at-home sampling and testing”. This trial process eliminates the need for patients to visit the sites. To ensure the integrity of the samples, clinical suppliers provide effective kits for home sample collection along with providing secure tracking, tracing, and logistical support for shipping and storage.
- Adopting self drug-administration procedures. This enables the patients to participate in treatment trials without the intervention of clinicians.
- Embracing wearable technologies and mobile health. This improves virtual monitoring and remote data collection.
- Flexible equipment and kit supply. This enables the clinical trials to get quick responses to new requirements or obstacles from the right provider and reduce the risk of costly delays.
- Working with companies who can meet the challenges of changing timeframes and also adjust the supply limitations. For example, Avantor Clinical Services during a study on COVID-19 faced a difficult supply chain. This led them to develop a two-phase approach that utilized the already available supplies along with holding the developing customized kits in stock and letting the trial requirements to get the standard items needed.
COVID-19 led the clinical trials to face a delicate balancing between the need to act quickly due to the essentials of the work and maintaining the resulting quality and validity of the research. And so medical personals are continuously adopting new trial protocols while partner companies and suppliers are adapting to be flexible to meet accelerated timeframes and decrease the hindrances in shipping and supply chains.
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