The key obstacles to the successful completion of clinical trials are the regulatory and ethical review, investigator selection, site commencement, participant recruiting and retention, monitoring, and data management concerns.
The only way to avoid these costly clinical research delays is careful planning, sorting out ownership issues in the initial steps, and a partnership based on shared concerns among all the stakeholders.
In the end, increased access to new treatments and their benefits for the Indian population will be made possible by such a common vision, enabling adherence to regulatory standards that improve the quality of trial conduct and more.
In this article, you can find some of the primary causes of delays in clinical trial data services and know how to prevent them.
A Business Approach To Clinical Trials
More reliable and standardized clinical research techniques are required due to the rising complexity of clinical trials. Therefore, researchers are encouraged to approach project management with a business-like mindset. Imperial clinical trial data services have produced a practical and comprehensive project management handbook for clinical experts to aid in the adoption of this strategy.
In over a quarter of all trials, strategic problems, commercial barriers, and operational issues were to a fault, according to a Nature investigation of the reasons behind clinical trial delays.
When a study is already underway, the most frequent cause of delay is the difficult and complex task of patient retention and recruiting, with many studies failing to enroll sufficient numbers of patients. Research by CenterWatch claims that 69% of patients fail pre-screening, 58% decline consent, and 8% drop out after enrolment.
When a study is already underway, the most frequent cause of delay is the difficult and complex task of patient retention and recruiting, with many studies failing to enroll sufficient numbers of patients.
Control Budget Negotiations
Due to complicated processes and numerous trial locations, budget talks may get restrictive. Therefore, sponsors might prioritize a few essential aspects to minimize time-consuming delays in budget talks.
Use of new tools and technologies in site management tasks
Another outcome of the recent research is the inadequate and improper use of the available tools and technology that results in adequate efficiency of site management procedures. A recent study has shown that it takes time for organizations to mainstream new techniques and instruments; as a result, many corporations prefer to test and pilot them solely on specific clinical investigations.
How to Overcome Clinical Research Try Delays
Provide the site(s) with a budget template.
Common fees, including regulatory (such as Institutional Review Board (IRB) original submissions, changes, renewals, and closeout), lab and pharmacy startup charges, screen failures, and other administrative/non-negotiable fees, should be included in the template.
Recognize the variations between a cost and a charge.
A charge is the price of the service to the sponsor and may be different from the cost, which is generally a fixed number and represents the entire amount of money required to deliver a service at the institution.
For example, a commercial clinical trial management system (CTMS) can be valuable.
A CTMS may help you organize all the papers, policies, and procedures that will support your study, find them all in one location, and help you manage your time well.
Clinical research facilities must be prepared to start taking patients by the site initiation visit.
To ensure the ancillaries and equipment are ready to use before the trial starts, MESM may work across all of a customer’s research sites.
Initiatives like creating a common investigator database or using software instead of spreadsheets and paper-based procedures have also shown to be effective in reducing timeframes.
More than half of clinical trial data services query stoppages involving images result in delays of up to seven weeks each time. These mistakes can be technological, such as inconsistent data entry, incorrect scanning mode setting, or human errors, like missing signatures, authorization, or unreadable handwriting.
Clinical trial delays are frequent but not always inevitable. Nevertheless, your trial could become a success for the sponsor and the participating patients by being aware of possible hazards and having procedures in place to mitigate them.
Incorporating the above tips can mitigate the risk of error and ensure the highest quality real-world evidence solutions.