Virtuous & vicious cycles:
These are the chains of events that can be complex, that are like dominoes and one thing is contributing to the second and the second to the third and third to further goes on and these are self-reinforcing heading in a certain direction. These cycles continues in that direction until an external force breaks the cycle and allow the chain of events to change.
These self-reinforcing cycles involve in the biochemistry of human bodies, in economics, in research world and in family dynamics.
Clinical research world:
In the clinical research world, sites and principle investigators are currently entangled with vicious cycles that are preventing their ability to substantially get better. They performances are getting worse with the period of time instead of getting better.
Reasons to failure:
Fifty one percent of the physicians and research sites fail when they try and do research. This is because of the regulatory burden, inability to pick the right trials, poor patient enrollment and due to small budget. They underperform, inefficient quality, poor timelines, and extended time to enroll patient and database lock and poor customer services.
Numbers of inclusion and exclusion criteria are increasing as the industry is getting smarter to put genetics and biomarkers such as the patients with improper genes cannot participate in trials in order to be treated with precision medicines and cures.
· IE criteria is disturbing for research trials as it increases, there are less number of people able to participate in trials that is less as compared to the real-world patients that is a scientific ethical issue. This gives the reasons for loosening of inclusion and exclusion criteria.
· The number of procedures for the clinical trials per patients is going up due to which they lose their rare patients as they get frustrated.
· In the present world, organizations are establishing more sites per trials due to which the patients are difficult to enroll per site that requires maintaining a larger trial volume that increase the regulatory burden and require more IRBs, research protocols, portals, usernames with passwords and a huge research staff.
These are the self-reinforcing vicious cycles increase the burden and reduce the site’s ability to be successful.
Break vicious cycle:
An external force is required to break the vicious cycle that is necessary in order to improve the abilities of the sites for their progress in research industry. Industry needs to recognize the cycle and tackle the dominoes in order to get rid of this cycle.