As we all know, each study comes with its own set of unique challenges and issues; however, there are a number of issues that continually pop up and cause big headaches for researchers everywhere. When you take a look at the list, as we will in a minute, you will see that there is no one area that is a “problem area,” meaning that the frequent issues that studies face don’t come from any one source, for example, regulations or patients. In this three part series of articles, coming out over the next few weeks, we will take a look at a total of 10 areas where problems can arise and present viable solutions for ensuring your organization does not get caught up with studies that won’t work.
In this article we will review 3 topics pertaining to external factors that can negatively impact a study.
Logistics can be a huge headache for any organization, especially for smaller organizations who might not have a person dedicated to ensuring that all of the necessary logistics are managed properly. Logistics is a very broad term, so for our discussion of reasons why studies won’t work, we will focus on two logistics related problems and outline some potential solutions. First, access to non-clinical supplies, such as bandages, syringes or medial tape. Second, availability of clinical supplies.
Let’s take a look at our first potential issue, access to non-clinical supplies. It may not seem like a big issues, but not having necessary basic items can cause delays in executing a study and ultimately put it on a path to lackluster performance from the start. An easy way to address this issue is to consider having a 3rd party manage non-clinical supplies, allowing you to forget about having to manage certain items and having the security that it will arrive as necessary.
Next the availability of clinical supplies can also be an issue. Let’s take a look at an example. Maybe a central lab requires 6-weeks to make and ship necessary kits, meaning that these kits won’t arrive in time for planned screening. Like non-clinical supplies this can dramatically impact a study’s timeline. A way to avoid this is to make sure that all timelines are checked and ensure that it leaves enough buffer to account for unforeseen events.
Another reason why studies don’t work out as well as planned is due to a multitude of training related variables. Some of the common training issues are poor training on efficacy endpoints, a lack of awareness of protocol procedures and gaps in GCP training.
There are a number of ways that training issues and gaps can be resolved. Let’s take a look at a few. In the case of poor training on efficacy endpoints a potential solution is to provide in-person training or to use the same person or rater for each efficacy measurement. Poor efficacy endpoint training can impact studies because it leads to inconsistent results. These two solutions address the inconsistency issues.
Other solutions include video recorded training, virtual refresher training and transition planner. These solutions work well to address issues related to a lack of awareness of protocol procedures. A number of factors can impact why a low level of understanding of protocol procedures might exist, but being able to provide recorded materials is a great way to get people back up to speed. This also helps in a high-turnover situation as well.
Thirdly, gaps in GCP training can be a major detriment to running a successful study. Some risks include, assuming that site staff has been trained on GCP can lead to audit findings, and ultimately may place subjects at risk. Some potential ways to address these concerns is to require accredited GCP training certification within the past 2-3 years, accept other accredited training programs and make available video recordings of GCP information.
There are countless personnel issues that can impact the performance and outcome of a study; however, there are two that stand out most. First, a lack of interest in a study from the PI. An example of this is a key PI has available patients that would be a perfect fit for a study, but does not recruit or enroll them. Potential solutions to this problem include adding additional sub-investigators who are interested, find another role for the PI in the study, or ultimately consider stopping the study if the PI truly shows no interest.
A second personnel issue is related to coordinator and recruiter time and availability. This can lead to studies competing with each other for resources as well as attention. This can be detrimental to a single or both competing studies. The primary way to avoid this is to have discussions with staff prior to starting new trials to make sure there is enough time and availability to complete it successfully.
Stay on the lookout for the second part of this article in the next few weeks.