Common Challenges in Conducting Clinical Research and How to Overcome Them
There have been some great years and some down years for approvals of novel molecular entities (NMEs) and biologic license applications (BLAs) from 2007-2016. Significant obstacles still need to be overcome in the worldwide clinical research trials industry, as seen by the gap between investment/activity and production. Three of the most pressing problems in the biopharmaceutical sector are discussed here.
A Brief Overview Of Clinical Trials
Human clinical trials have been conducted for millennia. Even earlier than that, the first clinical study was conducted in biblical times (about 500 B.C.). Since then, there have been numerous improvements and modifications to the procedures and guidelines for conducting ethical clinical studies. Studies like this are crucial for determining whether these medicines are suitable for wide distribution and usage.
Once confined to a small subset of the population, interest in clinical trials has surged due to the epidemic. Almost everyone has been wondering the same thing since the unique virus spread worldwide: when will there be a vaccine? However, that’s precisely what we’ll discuss today: the typical obstacles businesses encounter when conducting elaborate and pricey experiments.
Selecting Locations With Care
The quality of each participating site determines the trial’s overall success and the cash generated for sponsors. Because of this, choosing a location for a clinical study is a crucial step that might be fatal if taken too lightly. Herein lies the difficulty; sponsors must find a middle ground between thoroughly assessing locations during qualifying and dragging out the process to the point that it delays starting timeframes.
For sponsors, the obvious answer is to begin looking at potential venues as soon as possible. Sponsors need to think about things like the investigator’s record of accomplishment with trials, the volume of activity at the facility, and the availability of patients while doing their assessments. The success of your project hinges on these factors, so it is essential to give them plenty of thought while making your selections.
Coordination with Third-Party Vendors
Some sites, regrettably, are acquainted with the following situation: they have been chosen for a clinical trial, the necessary regulatory processes have been taken, and patients are waiting to be screened. However, due to a lack of collaboration with the study suppliers, the site cannot commence recruitment at this time. Site activation and enrollment will be delayed if supplies (such as test kits, study medicament, or electronic equipment) arrive late. Study sponsors may mitigate these problems by prioritizing communication and coordination, estimating vendor product deadlines, and establishing vendor availability well before the study’s planned launch date. Potential participants may lose interest in participation if they wait longer for screening if the two are not harmonized, and if sites are launched too early.
There is still a need to expand global clinical trials, and there are many unmet medical needs; however, these obstacles present opportunities to implement operational innovations that can speed the delivery of medicines (i.e., scientific and clinical innovation) to patients who need them by streamlining the trial process, improving decision-making, and boosting the likelihood of success.