November 30, 2022
It is quite common for clinical trials to face delays, and delays have almost become expected and acceptable. But unknown to many, clinical trial delays are not only costly but they also have a negative impact on patients’ health. This blog walks you through the common causes of delays in clinical trials and offers five tips to mitigate them.
Roughly, 85% of clinical trials experience some form of delay with about 94% of them being delayed by at least a month. Such delays constrain clinical trial budgets and in the long term, they shorten the patent window of a drug and hence minimize its profitability. The money lost to clinical trial delays has been increasing and is estimated to be in the billions of dollars.
Trial delays place an unnecessary burden on patients who have to wait for longer than they had expected. This may force some to exit the trial, and may cause even further delays to allow time for the recruitment of other participants. Delays in clinical trials cause delayed treatments and this may diminish patient outcomes. With all this in mind, it is imperative to understand the root cause of delays so as to come up with tenable solutions.
Poor planning is at the root cause of most clinical trial delays. Clinical trials are dynamic and evolving and hence different factors must be considered in the execution of a successful trial. This means that proper planning must be in place. Delays in as many as 25% of all trials have been attributed to commercial barriers and operational issues. The increasing complexity of trials with a multiplicity of endpoints on most trials places undue pressure on researchers, and results in delays. Communication barriers may also arise when trials are being conducted in multiple locations. Site initiation delays due to missed dates and poor planning are common occurrences. Once the trial is underway, patient retention becomes a significant cause of delay with over 50% of patients not showing up for pre-screening or declining to give consent. Another 8% usually drop out along the way. Lastly, operating in a tough regulatory environment may significantly impede the progress of clinical trials.
Given the evolving complexities and regulatory hurdles in the clinical research environment, it can be difficult to beat all the odds that cause delays. However, here are five tips to overcome delays in clinical trials.
Most of the causes of clinical trial delays can be attributed to poor planning. It is important to run through the trial from end-to-end and troubleshoot potential problems prior to launching the actual trial. Establish a working relationship and pinpoint unique challenges at each study site. Furthermore, you need to ensure that all your team members are onboard and aware of all important dates of the clinical trial.
Academic institutions and pharmaceutical companies have different requirements and protocols for reviewing clinical trials. Other regulatory requirements might also arise from the federal or state levels of governance. Failing to address these requirements in time may derail the clinical trial.
Communication breakdowns cause misinformation and misunderstanding among the trial stakeholders. It should be clear from the start where instructions are taken from and how any information should be disseminated. Objectives and responsibilities of each party need to be defined clearly. To achieve this, it is important to have an information management system to minimize information and other communication errors.
Delays in the system due to poor planning and communication breakdowns are a major cause of patient dropout. Patients need to understand the potential benefits versus risks of participating in the trial and be allowed to make an informed decision. Proper consent must also be taken prior to the trial. Clinical trial laboratories must take measures to boost patient retention through proper advocacy and communication.
A LIMS for Clinical Trial Management can help minimize delays in clinical trials by automating laboratory processes and streamlining workflows. A LlMS for clinical trial management manages samples and the associated patient information including consent, and supports regulatory compliance. Furthermore, it helps minimize delays in clinical trials and Contract Research Organization (CRO) operations.
The clinical research landscape has become increasingly difficult to navigate. Without proper planning, clinical trial delays are inevitable. This has hefty financial implications that are estimated to spiral into billions of dollars. When the entry of drugs to the market gets delayed, patient health is also jeopardized. Considering all that is at risk, it's only prudent to seek tenable solutions to mitigate clinical research delays. A LIMS for clinical trial management automates workflows to reduce trial delays.