Four (4) Common Pitfalls to Avoid While Designing Clinical Trials
Jun 10, 2020 14:21
A clinical trial is the heart of any drug developmental research process. After all, without proper clinical trials, your drug/device does not get to see the light at the end of the tunnel.
Designing an efficient clinical trial can be tricky. In fact, a recent study by MIT suggests that the average success rate of clinical trials is just about 14%. For some premium pharma and biotech companies, this could be a sigh of relief.
Because the success rate of clinical trials was previously thought to be just 10%.
Hey! In any logical sense, an 86% chance of failure is by no means an encouraging figure.
This is one of the top reasons why more pharmaceutical and biotech companies are turning to professional CRO companies like Novotech CRO. Outsourcing clinical trials to CRO can greatly boost the success rate of the entire venture due to their wider in-market knowledge and superior experience.
The mediocre success rate of clinical trials can be attributed to a large number of variables. Some of the most common pitfalls of clinical trials that you can easily dodge are as follows.
1.Unable to create a distinction between sales and research
Sales and research are two aspects that can appear deceivingly similar. But, they are NOT! And, the incapability to distinguish between these two factors is where the majority of companies, especially startups, face their first pitfall.
The vast customer-related knowledge of the field sales department is certainly enticing.
If you want to ensure a successful clinical trial, you should limit their input to certain key decision-making tasks like qualifying, contracting, or selecting the final clinical investigators.
Selecting a clinical investigator is one of the most crucial aspects of a clinical trial. They help manage the entire process of conducting clinical trials.
On the contrary, selecting clinical investigators based on the current/future sales prospect can diminish the overall quality of your trail. Not to forget it is against FDA regulations to market investigational drugs/devices.
2. Utilizing Under Qualified Research Team
Conducting clinical trials with under-qualified staff is probably the silliest error you can commit. The adverse consequences are, however, not "silly" by any standard. The consequence of using an unqualified research team is, well, your entire clinical research.
Of course, you can work towards equipping your staff with necessary information along the way.
The amount of time and resources involved in such an arrangement is mindboggling. Not to forget how inefficient it is to implement such procedures.
Conducting clinical trials demand a generous list of qualifications and expertise that only a few professional CROs can furnish. For instance, just keeping up with the latest FDA regulations can be a monumental task for your research team.
In addition, possessing an in-depth knowledge about the market and the ability to foresee and anticipate any form of risk or change in regulatory climate is something that you simply cannot manufacture.
The best solution?
You can either hire an experienced research team or outsource clinical trial to a professional CRO.
3.Underutilizing Research-related Technologies
We are in the golden age of technology, where everything seems possible with just a few clicks. The same applies to the developmental drug platform. There are (literally) thousand different tools/software that can ease up the entire process of clinical trials.
The vast majority of pharmaceutical companies remain oblivious to it. Either that or companies simply prefer sticking with the traditional practice of conducting clinical trials.
For example, research tools like Electronic Data Capture (aka, EDC) can help improve your decision making, aid regulatory compliance, and boost accountability. Such cutting-edge technologies not only help you save a substantial chunk of your research time, but are also a more economical option.
For instance, recent trends show that the cost of generating a single data entry query using conventional methods can cost up to $100 on average. That doesn’t seem too costly, is it?
Well, you fail to take into account that the entire process of a clinical trial involves hundreds and thousands of such data entries.
In contrast, utilizing research tools like EDC can minimize the research-associated cost to the bare minimum. And most importantly, such tools are far more convenient and efficient than traditional practices.
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