If you work in clinical drug development, you know it’s a complex process with an unfortunate 90% failure rate. This can be frustrating as not only is it detrimental to your bottom line, but it can also delay the release of medication that could be life-saving to patients. Many factors contribute to these clinical trial failures. Some occur during the pre-trial process, and some occur during sample handling, affecting data accuracy. Here, we examine two study issues that might impact the results of your clinical trials and two issues that could affect a well-conducted trial, potentially leading to unwanted results.
Have You Identified The Right Target?
Before attempting to develop a drug, it is vital to confirm that the cause of the disease is the molecular structure you are targeting. Before you start any clinical trial, you will need to undertake a variety of studies in various models, including genomic and genetic assessments. Unfortunately, there can be discrepancies between human models, animal models and in vitro models, which could lead to misleading results. This is a significant challenge for those who are attempting to develop certain drugs. In addition, it is vital to ensure that the drug molecule interacts with its target. Researchers should ensure that the pharmacological effects are not due to off-target effects but due to target inhibition. Overcoming these challenges in target validation can help negate the situation where drugs need more efficacy in clinical trials due to incorrect target validation.
Are You Overlooking Optimisation Issues?
The second reason why a clinical trial may not achieve the results you want is that the balance of drug exposure/selectivity in disease-targeted tissues vs the healthy tissues is overlooked. Optimisation should enhance the drug potency and specificity while maintaining desirable drug-like properties. There must be high exposure in the diseased tissue to maximise efficacy while minimising the exposure in a patient’s healthy tissues. This will help avoid toxicity. The problem is, when this is overlooked, clinical failures can be seen due to unmanageable toxicity or lack of efficacy.
Are You Obtaining And Storing Samples Effectively?
Various factors can impact the quality and replicability of samples during clinical trials. Inconsistencies in collecting, handling, and transporting samples can influence their quality, impacting your clinical trial results. If you are unsure whether the data you are receiving is accurate due to sample quality, it may be best to partner with a lab that has vast experience in ensuring the quality of collection, handling, and storage.
Are You Maintaining Accurate Records?
Maintaining accurate and secure records is paramount to ensuring the quality of the samples you are receiving. Tracking patient data is vital for analysis and data integrity. Utilising systems with a robust protocol for this will put you in the best place to ensure no discrepancies within the data you use to facilitate your clinical trial.
If you are seeing results that need clarification, it may be worth returning to the drawing board to ensure that the parameters used in your trial are accurate. Should you still have issues once this has been resolved, revisiting the sample handling and tracking processes may be useful to see if your trial results are accurate. If not, improving your data handling and sample collection may be a simple and relatively inexpensive fix for what might have been a very expensive and frustrating problem.
