Due to the recent Covid-19 outbreak, everyone around the globe is waiting for its vaccine/drug. But releasing a drug in the market isn’t easy, and proper clinical trials must be done to check its effectiveness and the side effects associated with it. These clinical trials require a significant amount of time and a huge budget to compensate for the required costs.
But estimating the time and budget is next to impossible because of various factors that might hinder the trials and further add further to the cost. So, it is important to consider these variables that might change the budget and timeline of the clinical trials.
Some of the major challenges while estimating the budget are:
1. Trial delays:
Clinical Trials are a pretty complex process often prone to errors. These errors cause failure in meeting recruitment deadlines, changes in the schedule, etc. Thus, changes need to be made and these changes cause delays in trials that can sometimes cost as much as half the previously budgeted amount for the clinical trials. It’s pretty important to take into consideration the trial delays while making a budget.
2. Lack of proper communication channel:
While conducting the clinical trials, a proper communication channel between the sponsors and the contract research organization (CRO) is required. Sponsors and CROs communicate with each other about the prices, status, and changes in the clinical trial.
Without a proper communication channel, it will take a lot of manual effort and will involve frequent travels further adding to the already high cost of conducting a clinical trial.
3. Unforeseen events:
There are various unforeseen events that can’t be predicted beforehand and are unavoidable. These events include adverse effects of the drug on some participants due to existing conditions, reaction with other drugs, or physical injury.
These adverse effects range from minor ailments to death so the trial needs to be stopped and a thorough examination of the subject is required which wastes time as well as a lot of resources. The budget takes a severe blow due to the unpredictability of these events.
4. Lengthy recruitment process:
Recruiting appropriate people for clinical trials is a pretty lengthy and tiring process. Volunteers are needed to test the drug on, doctors and nurses are required to take care of the volunteer and get regular reports from them.
Nowadays, trials are being outsourced to preclinical CROs which then handle the recruitment, clinical operations, etc. on their own. But the CROs are changed midway when they don’t perform well or because of budgetary changes which further delays the trials costing more money to the sponsor.
5. Updating the current system:
A new drug takes about ten to fifteen years before making it to the market and in that time period a lot of things change like previously excel based systems were used which were slow and prone to errors resulting in more operation and handling costs.
New machinery might be required for the production of drugs as the old machinery would have become inefficient or completely useless. The manufacturing and reporting system updates costs take a huge chunk from your budget but are necessary and can’t be ignored.
Nowadays more and more clinical trials are being sponsored by private industries and these industry-sponsored clinical sites tend to look for ways to cut costs for huge gains. But the above-mentioned factors make budgeting of clinical trials next to impossible.
The right budget management system will let you easily share, review, approve, submit, and will display the process flow and approvals using a simple user interface with just a push of a button. It will not only help in budgeting but also in increasing the overall profits of the company taking care of the various challenges that might occur.