With evolution of old concepts and coming up of new innovative concepts, the clinical trial industry has seen a very exciting year in 2018. Digital health and AI concepts have been the main focus of the industry, with the concept of patient connectivity and information exchange being the new idea.
- The basic concept of patient information exchange is centered on enhancing communications between patients and sponsors, and tending to patients’ needs for information before, during, and after clinical trial participation. The patient is considered in study design, awareness is raised about clinical trials with patients in communities, supplementary materials are provided to patients during the trials, and data is given back to the patients after the completion of the trial. All of this improves patient experience in clinical trials. By the end of 2018, it has been identified that the clinical trial landscape is very competitive. This is why collaborative approaches with patients during study design is considered to be one of the most important aspects that attracts and retains patients by creating studies around their lives. There are certain organizations that are also supporting study sites with tools, resources, and information that can assist patients through the clinical trial journey.
- The internet and artificial intelligence are also being significantly used to maintain patient engagement with the studies. Digital health is of prime concern, where various factors ranging from wearable devices to digital biomarkers are being used. In addition, continuous data collections and the need for improved data quality is sure to drive digital transformation even further.
- Blockchain is another element that is yet in the early stages in the biopharmaceutical industry, but yet has a lot of potential in clinical trials. It can be used for screening, recruitment, clinical trial registration, source documentation, and much more.
- Quality management analytics has also broken through many areas in clinical trials, and has also started to impact regulatory agencies. The biopharmaceutical industry continues to advance quality measures by incorporating quality tolerance limits to expand adherence with new guidelines. These limits impact protocol design, clinical study reports, and risks management.
- Risk based monitoring practices are starting to scale in the clinical trial industry, with the most commonly known key risk and performance indicators being quality indicators, cycle time indicators, and efficiency indicators. Such risk based monitoring service providers are offering targeted solutions today.
With all of this been seen in 2018, what should we expect in the new year? On the patient information exchange and connectivity front, we expect to see more biopharmaceutical companies targeting recruitment, enrollment, and retention. In addition, clinical trial data exchange may not be seen with patients after the completion of the study. On the digital health front, we expect to see many new validations and measures using electronic digital reference objects. On the blockchain front, we expect lesser blockchain pilots. However, more of artificial intelligence based technologies are expected to be seen. All in all, many novel quality management concepts are expected to emerge with the coming year. But, one thing that is not going to change is the quality of clinical research education being provided through the clinical research diploma courses in Bangalore provided by professionals at Avigna Clinical Research Institute. Here, you can have yourself enrolled and get the finest quality education right from the comfort of your home, without compromising on your current lifestyle, job, and responsibilities!
