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: