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4 Hurdles to Overcome When Planning a Clinical Trial

Clinical trials are increasing by about 12% every year. Clinical research is quite expensive, and this is the major issue that faces pharmaceutical companies when trying to come up with new drugs. The Tufts Center for the Study of Drug Development reported that the cost of drug development has increased by more than 400% over the past twenty years. Other than the Veristat clinical trials cost increasing, there are other hurdles that slow down the efforts of R&D in pharma companies. Here’s a deeper look at some obstacles you’ll overcome during the clinical trial planning phase.

Patient Enrolment and Access

There is a need to recruit and retain patients during clinical trials. Most clinical trials will demand patients in the thousands. In most cases, these patients are not on the same site. This leads to most CROs conducting virtual clinical trials to ensure that they keep the enrolment number as required. Today the number of clinical trial dropouts is at an all-time high. Most patients end up seeking other forms of treatment.

Strict Regulations and Approval Delays

The pharma industry is highly regulated. It is becoming harder to meet compliance obligations. This makes it harder to finish the clinical trials on time and in a cost-effective way. Global trials are becoming harder because different regions have different regulations. This means that most CROs are bound to deal with approval delays when conducting their trials. To counter this problem, you have to ensure you have an exceptional record-keeping system to help you keep track of all the scheduled dates for ethics as well as the submission days. This will help you keep the timelines on track and avoid delays where you can.

Data Management

One of the most important aspects of a clinical trial is data management. When a trial is ongoing, you must ensure that all sites are well-monitored and all the data is well captured. Monitoring the patients’ progress all through the trial is of utmost importance. You have to make sure that monitoring of endpoint data, any adverse events, and deviations are all recorded. All lab results, imaging results, and health records need to be integrated as quickly as possible into a database. For seamless data management, you need to acquire software for data management that will help you centralize information through the clinical trial. This will make access to data as fast as possible.

Management of The Clinical Trial Site

As clinical trials increase, it is becoming harder to identify problems and make decisions in real-time. Due to the geographical complexities, it becomes harder to access data from different sources as fast as they would like. About 66% of clinical trial coordinators say that they use a manual spreadsheet to make decisions for their sites. This problem can easily be solved by using management software that will centralize data and ensure real-time reporting. This is easier than looking through papers to make a decision.

A successful clinical trial requires quality data processing and seamless report delivery. In almost all cases, you will find that the right software will make all the difference.

 

 

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