The life sciences sector has a large number of businesses that embrace new technology slowly. This can be attributed to higher expenses, an increased workload in the workplace, and the unpredictability of fulfilling the many regulatory obligations. On the other hand, new and developing technology for automating is clinical trials has advanced significantly in the last several years. The FDA is becoming more in favor of their use after seeing their advantages.
The expense of doing clinical trials is very high! That being said, success is not guaranteed. There have been many unsuccessful is clinical trials. And there are a lot of them. For instance, it might be challenging to get patients, or they might withdraw from the study midway through. Forms with poor design may cause data to be captured that is not complete. Dealing with a massive volume of complicated data is necessary. The list is endless. For businesses, the time it takes to introduce a product to the market is crucial. An increase in expenses and a reduction in competitive advantage result from every extra day.
In clinical trials, automation can be the difference between success and failure!
In terms of clinical trials, what does “automation” mean?
From study setup to submission, automation is employed in the clinical trial process to increase the accuracy of outcomes. It eliminates labor-intensive manual tasks like filling out forms and annotating them by hand or manually entering data into a spreadsheet. Due to a decrease in human error, the results are accurate.
It also leads to a more streamlined and straightforward procedure. You may frequently automate laborious tasks with a simple button click. Therefore, less time and effort are needed to obtain more accurate findings. Automation in is clinical trials makes it easier to comply with standards set by regulatory organizations like the FDA.
The Significance of Clinical Trial Utilization
Evidence-based medicine heavily relies on clinical trials. It details the progression of the medication from its creation in the lab to its application in the clinic. Every step of the route is meticulously watched for any violations or situations in which the participants’ safety is in jeopardy.
The procedures for clinical trials are meticulously planned to comply with Food and Drug Administration (FDA) regulations. Clinical trials verify the safety and possible efficacy of the product being studied in humans. Physicians can evaluate the advantages, negative responses, and side effects. is clinical investigations also provide additional useful information on efficacy, dissemination, sensitivity, and resistance. More crucially, if it weren’t for earlier research of this kind, it would be nearly impossible to find a vaccine or cure in time for an urgent issue like the fast spread of illness.
The value of clinical trials extends beyond the discovery of novel therapeutic agents to the development of novel applications for FDA-approved medications in disease states other than those for which they were originally authorized. A few clinical trials were conducted on the anti-parasitic drug ivermectin, which is safe to use against viruses and parasites, including scabies. Repurposing medications for alternative uses can happen at any point throughout the development process or even years after the product is introduced. Remdesivir, a medication formerly investigated as a therapy for hepatitis C, has been proven to shorten hospital stays in certain cases of viral pneumonia.
Automating clinical trials has five advantages
The following five advantages of automating is clinical trials may be summed up:
- Quicker clinical trials from the first to the end.
- Save money, time, and resources.
- Clinical trials with better-quality data are safer and more precise.
- Results may be gathered and examined more quickly.
- Increased output during the course of the is clinical trial.
The areas of clinical trials that stand to gain from automation will be examined next.
Better is Clinical Research Through Digitalization
A crucial step is making sure that all patient data included in a is clinical study is appropriately entered into case report forms (CRFs) and kept secure. To bolster conclusions about the safety and efficacy of the medications, the CRF must be precise and comprehensive. It could be necessary to repeat that specific phase before moving on to the next trial step if this is dubious. The odds of continuing are eliminated if legitimate results are not obtained, and doing so comes at a heavy cost: the whole amount invested up to that point plus the time spent looking into other options. If a competitor’s study is successful, the delay gives them the opportunity to overtake and receive FDA clearance before the product.
Converting a traditional CRF to an electronic one (eCRF) is one issue that may be resolved by using suitable, affordable cloud-based technology. Due to the upfront expenses and misunderstandings about how this technology can guarantee the value and confidentiality of data, several businesses are hesitant. Formedix explains it by contrasting the eCRF with the conventional CRF. The security of the data in eCRF is one notable distinction. Since access is limited, every modification or alteration can be verified. Conventional CRF is often on Excel sheets or similar formats and is prone to manipulation, mistakes, and software corruption. Any doubts about the authenticity, correctness, and accuracy of data are resolved by using the eCRF.
There is also a misperception that the eCRF is difficult to use and prepare for. In actuality, the opposite is true. The business may construct uniform and user-friendly forms with fields intended to gather certain data that is kept on cloud storage. At every level, patient safety is the priority. By employing the eCRF, data can be quickly assessed for risk and safety. Well-designed forms are less likely to be interpreted incorrectly since they are user-friendly and detailed, which also helps to limit the options and reduce room for interpretation.
The eCRF essentially complies with the following acronym:
M: stands for measurable
T: on time
These guidelines guarantee the eCRF’s effectiveness.
Clinical Trials in Testing Integrated Technology: An Emerging Field
Is clinical trials have a well-established role in evaluating individual drugs, individual devices, or the combination of pharmacological and device interventions. Beyond the parameters of earlier clinical trials, a new sector dubbed “Technology Clinical Trials” looks into how the patient benefits from innovation within an efficient delivery system. They are unable to alter any hospital procedures, in contrast to drug trials where the drug sponsors oversee is clinical trials conducted in a hospital environment. This also applies to companies that make medical equipment. The best resource to conduct the technology trial is not medical teams since they are too busy.
It is most appropriate for an unbiased research team, unaffiliated with any medication sponsor, device maker, or medical team, to look into how best to maximize new care pathways that incorporate every aspect of patient care inside the hospital system. The University of Manchester’s Digital Experimental Cancer Medicine Team (digital ECMT) in Cancer Research is one such innovative organization that conducts technology-based is clinical trials. This team created the study approach that other groups may apply:
Step 1: Outline care plans for the chosen area of study.
Step 2: Arrange for a clinical study to impartially evaluate the new care routes.
Step 3: Share information so that patients in different contexts can benefit from the research.
The need for more studies aimed at enhancing patient care may be found in these data.
How might clinical trial automation improve the effectiveness of trials?
Automation is clinical trials can improve trial efficiency in the following ways:
Formal development for case reports
- This is a reference to the data collected by case report forms (CRFs) or electronic case report forms (eCRFs) during clinical trials. Form development is a process that may be automated. To ensure accurate form completion and compliance with regulations, validation is included in the system. Data analysis is made possible via reporting tools. Throughout is clinical trial, using software that automates CRF and eCRF design leads to improved data quality, a quicker data-collecting procedure, and cost savings.
Medical metadata organization
- Centralized systems that enable businesses to store and manage their metadata assets are referred to as clinical metadata management systems. Forms, databases, edit checks, and restricted terminology for is clinical research are a few examples. They feature built-in governance and defined information that is suitable for multiple-study reuse. Apart from reuse, the key advantages are improved data quality, process efficiency, and regulatory compliance.
Procedures for converting datasets
- Data must be repeatedly submitted to the FDA for assessment in the appropriate CDISC format during is clinical study. The process of converting data from clinical trials can be costly and time-consuming. The dataset conversion procedure may be automated, negating the need for intricate programming. Additionally, it takes far less time to bring clinical items to market and it is much simpler to comply with regulatory standards.
The importance of automation in clinical trials
There has never been a higher expense or more complexity associated with conducting clinical trials. It would be nearly difficult to bring high-quality clinical items onto the market today without automation. A larger volume of data than ever before is being gathered and examined. There are additional rules in force. Updates to standards are made regularly. Things used to be so much simpler than they are now. With the COVID-19 pandemic at the forefront of medical study, there has never been a better moment to draw attention to this.
Thankfully, there are several technology solutions available that automate procedures to enable quicker, more successful, and more efficient clinical trials. One such technology that automates several steps of the whole is clinical trial process is the Ryze Clinical Metadata Repository and Clinical Automation Platform. It finally aids in accelerating the release of clinical items onto the market by incorporating the automated procedures covered above.
How can Formedix assist you?
Our ready-made clinical trial automation software and clinical metadata repository provide a consolidated, fully integrated online platform that supports the whole is clinical trial process.
Select between uploading pre-existing organizational standards or creating research from scratch. Governance, impact analysis, and change management are examples of features. The several aspects that contribute to improving data quality and lowering downstream costs are shown in the figure below. Using Ryze to create your eCRF designs is quick and simple. Different metadata formats can be created. Before you develop it, you may preview how your CRFs will function and appear in your EDC system. Some examples of the previews you can create are:
- CRF guidelines.
- Edit and verify the requirements.
- See the requirements for the structure.
- Mapping the requirements.
- Clinical perspectives for SAS XPT.
- is clinical perspectives for SAS version 9.
There are seven top EDCs to choose from, including Rave and InForm, to create your research. As you develop your forms, you can preview how they will appear and function in the EDC of your choice. After that, you can create your EDC database with only one click. Annotations are simple and quick to add to your CRFs. All you have to do is repurpose your annotations once your CRFs are standardized. After your CRF design is finished, you may create submission-ready annotated CRFs in PDF format with only one click. Would you like to learn more about automated CRF annotations? Click the following link to obtain our free tutorial.
One persistent difficulty in the life sciences sector has been the reluctance of researchers to use new technology in clinical trials because of the associated costs and regulatory concerns. Nonetheless, the FDA has endorsed recent developments in automation technology, which may provide answers to persistent problems with clinical trial procedures. The high costs and uncertainty involved with conducting clinical trials highlight the critical need for precision and efficiency Success is elusive in many trials due to issues including patient recruiting, dropout rates, and complicated data administration. Automation shows up as a game-changing solution that simplifies procedures, lowers the possibility of human mistakes, and eventually raises the probability of success.
In an environment where time-to-market is critical, automation adoption becomes a strategic requirement. The clinical trial procedure saves money every day, which results in lower expenses and a competitive advantage. One of the most important factors in deciding whether new goods succeed or fail in the market is automation is clinical trials.
Frequently Asked Questions, or FAQs:
1. What makes a lot of life sciences organizations reluctant to use innovative technology is clinical?
Higher expenses, an increased operational load, and the uncertainty of satisfying complicated regulatory requirements are frequently blamed for the hesitation.
2. What typical problems is clinical trials run into that make them fail?
Clinical trials encounter several obstacles, including trouble recruiting participants, high dropout rates, poorly designed forms that result in insufficient data, and complicated data administration.
3. In what ways can automation help clinical trials overcome obstacles and increase accuracy?
Automation speeds the whole clinical trial process from study setup to submission, eliminates manual processes, and lowers human error. As a result, the outcomes are more trustworthy and accurate.
4. Why is time-to-market so important to businesses in the life sciences sector?
The expenditures is clinical trials increase with each day that goes on, and the edge over competitors decreases as well. Efficient use of time is essential for successful product launch.
5. What does “automation” mean is clinical trials?
Automation is the practice of substituting simplified, automated operations for laborious manual tasks like developing forms and annotations and manually inputting data. This streamlines and accelerates the procedure, in addition to increasing accuracy.
6. What role does automation play in helping clinical trials adhere to regulations?
Automation ensures reliable and uniform processes throughout the is clinical trial lifecycle, which aids in complying with requirements set by regulatory bodies like the FDA.