Why you should use a clinical audit checklist?
A clinical audit checklist ensures that the research protects all the participants’ welfare and rights. It also guarantees that the data gathered during the trial is credible, valid, and beneficial.
Procedural errors can render the data unusable. When this happens, the research team will need to conduct the studies again. It is the reason why clinical trials are expensive and time-consuming.
Using a clinical trial audit checklist ensures that you are compliant with the established clinical research standards. It includes all aspects, like patient safety, data collection, and Good Clinical Practice guidelines.
In this article, the following points are explained:
What is the purpose of a clinical audit checklist?
A well-planned, properly executed, and thoroughly monitored clinical trial makes the generated data credible. For this reason, a clinical trial audit is always necessary. It identifies potential problems early on. It helps the team come up with solutions before the research becomes unsalvageable.
Planning for a clinical audit is one way for sponsors and research teams to ensure that there will be no issues with their clinical trial. An audit appraises the quality of data gathered by the research team. Using a clinical trial audit checklist, the team can reduce expenses and keep the project on schedule. It also helps guarantee regulatory compliance.
3 steps of successful clinical trials
Pharmaceuticals and medical devices undergo clinical trials before introducing them to the public. Clinical trials, however, are prone to failure. Because of this, most drugs and vaccine candidates fail.
An MIT research group published their study entitled Estimation of Clinical Trial Success Rates and Related Parameters in the journal Biostatistics in 2018. Their research showed the overall probability of success for all drugs and vaccines is a measly 20.9%. That is if you exclude oncology drugs, which have a meager 3.4% success rate.
Gathering valid and sufficient data is crucial for determining whether it is worthwhile to continue a clinical trial. Investments, such as time, funding, and human resources, grow as the clinical trial progresses. The cost of failing stage 3 in a clinical trial is associated with the cost of all prior steps. Often, a failed stage 3 means the team also must conduct stages 1 and 2 all over again.
The team cannot afford any failure at any stage of the trial. For this reason, they must follow the principles for best practice in clinical audits. Sticking to the standards ensures a successful clinical trial.
The team should thus know how to perform a clinical audit themselves. They must conduct an internal clinical audit before embarking on the project. They could hire an independent investigator audit during the conduct of the clinical trial. But following a clinical audit checklist during the planning stage is vital to the success of the project.
Clinical trials often fail to demonstrate the safety and efficacy of a product. The team should be on the lookout for the most common reasons clinical trials fail. They must, at the onset, make sure that:
1. The End Product is Safe and Effective
Ensuring optimal efficacy and safety is a crucial factor during the clinical trial process. The team must anticipate, prevent, and assess any incident that can harm the participants. The most common adverse events in clinical trials include vomiting, nausea, myocardial infarction, and liver failure. And the best time to consider these issues is during the planning and designing stage.
Some clinical trials might fail due to inadequate efficacy. And some of the reasons behind this include a flaw in the study design, inappropriate efficacy endpoints, or too small sample size.
These are possible issues that a clinical trial audit checklist can help mitigate. It is crucial at every stage of a clinical trial to put safety and efficacy as primary concerns. The cost of uncovering these issues increases as the project progresses.
2. The Study Design is Appropriate
A flawed study design cannot accurately demonstrate the safety and efficacy of the product in the target population. A clinical trial audit checklist ensures all aspects of the study design are appropriate and optimized.
Fundamental design issues, including the ones related to randomization and analytic methods, are common in many clinical trials. But with a clinical trial checklist, you can make sure you have all aspects covered. For example, if you are doing a randomized controlled trial, you must conduct each step well, from gathering your research team to analyzing the data.
The design must have a clear definition of the research question and minimize variation. It must also address randomization and stratification, placebos, and blinding. The selection of the control group, the target population, endpoints, sample size, and interim analyses are equally important. Your audit checklist should include all these to avoid flaws in your study design.
3. There is Available Funding
The costs required to complete a clinical trial could take millions or even billions. Pfizer, for example, reported that the research and development costs of their COVID-19 vaccine reached $1 billion.
Pharmaceutical research and development projects are expensive. Apart from paying for materials, storage, staff, and patient compensation, you also must make sure you comply with regulatory burdens.
With such kind of financial demand, many clinical trials go underfunded. Some may end up shelved as they fail to follow the principles for best practice in clinical audit and at the same time produce positive outcomes.
A clinical trial audit checklist ensures there is a prepared budget for the fixed costs, related costs, drug costs, subject costs, ancillary costs, and marketing costs. Since the checklist itemizes all requirements, it can accurately show the price estimates of all elements. It reminds the research team of institutional fees and records retention fees. These are costs that teams often neglect and forget.
The clinical audit checklist should also allow the team to plan for hidden costs such as inflation and health system price increases. These are possible cost increases for clinical trials that go on longer than one year.
Governments require clinical trials to undergo strict monitoring. By choosing to use a clinical audit checklist, sponsors can ensure their projects follow the principles for best practice in clinical audit. Doing so increases their chances of performing well during clinical trial audits and inspections by the government.
An app for better clinical audits
Many things have to be taken into account for a clinical trial to be successful. This makes reliable documentation and a lively exchange within the team all the more important. The use of paper can make this procedure more difficult and also prone to errors. One solution that promises success is to switch to a digital app and desktop software.
A powerful and mobile solution like the one from Lumiform allows leaders to streamline data collection and report for clinical audits, easily identify deficiencies in current practices, and improve the quality of patient care. With the mobile app, you can:
- Conduct clinical audits using forms and checklists from your mobile device.
- Adapt checklists or create new ones at any time with the help of the form builder. You can also use our extensive template library.
- Add photo evidence to your checklist and comment on it.
- Automatically generate clinical audit reports and share them with members in your organisation.
- Get real-time clinical audit data and actionable insights with Lumifom Analytics.
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