The race to a Covid-19 vaccine continues! With clinical trials in progress (currently at the final stage of testing), researchers, scientists, and physicians are working endlessly to ensure that treatment is found. Drawing valuable conclusions from the statistics involves careful monitoring of the clinical trials in place. Physicians implementing clinical trials need to follow specific protocols. We take a look at the keys to success with the Coronavirus vaccine clinical trials.
1. Broadening testing groups
Scrutinized for testing, the trials applied solely to healthy individuals. The clinical team needs to broaden testing to most affected and vulnerable groups and at a higher risk of death from Covid-19. Consequently, these include those individuals with compromised immune systems, existing diseases, obesity, etc. This implies that results will be applicable only for these individuals.
WHO drew up a Global Target Product Profile (TPPs) to assist vaccine developers, WHO for COVID-19. The TPP has a comprehensive outline of the minimum and desired attributes of safe and effective vaccines. Moreover, these requirements cover two types of vaccines: vaccines that offer long-term protection to the highest groups of people at risk for COVID-19 (healthcare and clinical workers), and vaccines for use “in response to outbreaks with rapid onset of immunity.”
2. Establishing a long-term commitment
The point of these clinical trials is to ensure that the positive results of the testing can be applied to the whole general population. The tests, therefore, will go through a variety of people. Subsequently, this will happen for years to come. Clinical trial investigators need to make a long-term commitment to this testing and ensure that they have sufficient capacity and resources to undertake the clinical trial for years to come.
3. Hiring clinical trial coordinators
The vaccine is a race against the clock—following protocols and thoroughly analyzing data. Accordingly, a team of dedicated clinical trial coordinators may be hired to help staff personnel not fully equipped to handle the stress. Clinical trial coordinators will ensure a quick turnaround time with data analysis. The coordinators prevent issues such as patents from expiring and the loss of clinical trial sponsors.
4. Readily-available clinical trial sponsors and financial assistance
Clinical trial sponsors need to be readily available to promptly secure revenue for both physicians and patient revenue management services. This needs to happen every quarter of the trial. Clinical firms should negotiate a budget that works for all parties involved. Moreover, it would cover the cost of data collection and reports, storage fees, the cost of retaining subjects, and overhead expenses.
5. Thorough testing procedures
There are increasing pressures that come with the development of a successful vaccine. Additionally, there exists an equally challenging demand for its distribution on a wide scale. Every one of the clinical trials and vaccines produced will be thoroughly evaluated until it is a success. This will need an extended time period, as well as additional resources and financial assistance.
Project management support for the frontline clinical industry
While clinical research support teams rush to ensure clinical trial vaccines are safe and effective, there is an increasing need for all parties involved to support and anchor their efforts. Each department, from IT support to finance, is necessary for its effective implementation during the clinical stages.
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