Software development has evolved via structured model creation. As we progress further in the 21st-century digital world, applications that require software models to be created are also requiring those models created to be adaptive, iterative and sufficient documentation of the coding involved. A new approach to software development termed as the agile software development began at the start of the 21st century. It along with similar programs emerged to address the dynamic nature of work in various sectors like e-commerce, health, retail, finance, insurance, etc that traditional models of software were finding difficult to provide solutions.
Clinical research has emerged as a 21st-century sector that is at the interface of health, pharmaceutical research, new drugs, and treatments along with the inclusion of software models to help with the vast data banks associated with clinical research. Software model adoption by the clinical research industry is important for both financial reasons and also efficiency reasons. By efficiency reasons what is meant is that software models enable quicker research timings in the lab during primary drug development research and help in storing and managing large patient information databases among others.
While traditional models of software have to an extent been able to help clinical research processes, reduce costs, manage patient information, help drug development research, they have not been able to adapt to real-time changes during the clinical research processes like clinical trials. Requirements for a trial may change during the process and associated software models need to be responsive and appropriate change.
An agile approach to clinical research processes like clinical trials or clinical monitoring need not only be through software models. It can also be a change in conventional modes of responding to events in a clinical trial or drug development. For instance, interactions between those who develop software models for clinical research can interact with clinical research professionals on a real-time basis for better input in designing more efficient software programs that are dynamic and adaptive.
Traditionally in clinical studies, randomization and trial supply management (RTSM) help randomly allocate patients to a trial and ensure that an adequate and balanced trial design has been created. Also, it ensures that trial supplies are provided wherever necessary in the required amounts. Clinical trial protocols are electronically developed using plan driven models that again follow the conventional waterfall method. But the problem with an approach like the waterfall method is that only after the first step in the model was completely satisfied with the system progress to the next step. A sudden change in the requirements at step 1 is difficult for the traditional system to address. Hence agile methods will prove to be a game changer in addressing the dynamic nature of clinical research processes. Some of the advantages that an agile approach can provide clinical research are as follows:
- An agile approach is able to develop a high-quality clinical trial software (CTS) system that was well within the budget and did not require additional resources.
- Since trial or study protocol design is accomplished comparatively quickly, there is less waiting time between steps and the research team can focus more on solving problems rather than spending disproportionate amounts of time in micromanaging protocol design and its customizations.
- Development of a dynamic CTS that stores and manages trial data will offer multiple financial benefits for the organizations conducting clinical trials.
- An agile approach promises faster project completion of a clinical study. While traditional studies may take around 8 weeks to complete, an agile clinical study system can reduce the duration to 5 weeks from the beginning of study protocol to patient responses.
- Patients have diverse needs within a trial or study even after a standardized protocol is designed and applied. An agile approach can help in designing protocols that are standardized yet can accommodate specific needs of patients without customizing too much.
- A reduced customization also helps in reducing costs associated with the designing the trial or study and improves the time in which they are designed. This helps lower the overall time taken by a clinical trial or study to complete.
- Since the agile approach makes the CTS flexible and easy to understand and follow, the clinical research sponsors need not always be micro-managing and assuming the role of project managers. Engineers or primary investigators can take charge of the CTS too thus improving efficiency.
- An agile model allows for faster problem resolution because people directly involved in the trial are also able to manage and monitor the CTS.
- Agile risk-based monitoring is enabled by an agile approach due to the presence of a multivariable model and the comprehensive metrics used in monitoring patient safety and data quality.
- An agile method also helps in recruitment of patients for participation in trials or studies. The easy to understand flexible model can help sponsors attract the right volunteers with their full consent.