By Jubilant Biosys

10/12/2020 Be it a clinical trial for developing a device or a drug, the number of risks involved can be quite high if the whole process is not conducted the right way. Due to these risks, the trials can derail from their initial path, which can even lead to the sponsors losing faith in the trials. Therefore, it is incredibly crucial to minimize risks in clinical trials.
While Phase I trials are conducted usually on healthy people to understand the side effects, the next Phase II and Phase III trials are conducted on patients to see the effectiveness and identify the safe and ideal dosages. After completion of these three phases, the authority takes the final decision of approving or disapproving the drug. Phase IV trials are conducted to make improvements in the effectiveness of the drug by changing the composition.


Challenges in Clinical Trials:

• Improper trial design and erratic endpoints
• Unreliable trial data and the failure to detect such discrepancies
• Failure by the team to understand the regulatory norms and feedback on time
• Scattered data that leads to poor data quality
• Non-availability of vendors and resources

Now that you know the basic challenges faced in most clinical trials, let us look at the four ways that can help minimize the risks that these challenges can cause.

Making sensible investments to improve data quality:
One of the biggest issues faced in any clinical trial arises when the collected data is not correct. Since this is the first and most important step in the whole process, it is absolutely crucial that you invest in an experienced clinical data collecting team or a Contract Research Organization (CRO) that offers quality and integrated drug discovery services.

The experts in the team should have all the technical know-how regarding how to build a robust database build and management system. You should define a clinical data strategy right from the start so that the required quality is known from the start.


Including a biostatistician and a consultant statistician in the team:
A biostatistician is someone who understands the study design completely and makes suggestions on hypothesis testing and analysis. One of the common mistakes many sponsors and CROs make is that they bring a biostatistician in the team mid-way through the trial, which is quite late in most cases. Therefore, you must include such a professional right from the start so that he or she can help you with protocol development, data collection, management, and reporting.

Similarly, a consultant statistician can solve the problems that occur with trial design and data analysis. In fact, including both of them right from the start helps in the early detection of problems, which helps in the timely termination of a trial and hence saving a lot of money.


Centralizing the clinical data:
Just like any work, if a lot of people are involved in it, a clinical trial can experience several problems. Therefore, the best way to go about the whole process is to reduce the number of vendors and go for a vendor that specializes in both clinical and preclinical CRO for research. You should centralize the services of biostatisticians, data collectors, and medical writers so that it saves time to collect and analyze data.

The quality of the data can be improved drastically thanks to this standardization. More importantly, the communication between the sponsors and CRO also improves, which is crucial to get successful results.


Using a strategic FSP model:
A Function Service Provider model focuses on providing a robust team with experts that performs particular functions so that you get quicker and better results. With such a model, the sponsors are in a better position because they do not have to spend a lot of money on recruiting new staff from in between the projects. The Contract Research Organization (CRO) is supposed to come up with resources that will enhance the results in a significant manner.

With these helpful measures incorporated within clinical trials, we have seen a substantial improvement in the management of data and getting better results.

For more details about clinical researches: https://www.jubilantbiosys.com/