This last year 2019 has come to an end and a new one begins. Last year was filled with new opportunities and challenges in the clinical research industry. We have witnessed a lot of advances in the technology part regarding clinical research. For example, we have seen an increase in the use of tablets for answering health quality questionnaires and a more frequent use of wearable devices in order to monitor more closely the health status of a patient. We have also seen a boost in remote monitoring and risk-based monitoring practices. We have also participated in new trials with new molecules that may change the future of what we now know regarding some therapeutic indications, for example, renal cancer, melanoma, chronic kidney disease related anemia and migraine. So, what’s new for this 2020? What can we expect this year?
One of the new things that we surely will begin to see are the virtual clinical trials. A virtual clinical trial is one where the patients don’t have to attend the clinical research site or hospital in person, that is, they can stay at home, either for all visits or for the most part of them. Data is collected utilizing biowearables or other sensors. Of course, there are a lot of questions regarding this model, such as if patient safety is ensured or if the data is reliable. If the patient population is not at a very high risk of having adverse events and if the disease is not life threatening, this model could work very well. If it is a disease where patients need to attend the clinic to treat their disease, then it would have a lot of challenges and maybe doing the trial virtually would not be possible. Regarding the reliability of the data, the patients would need to be very compliant while using the wearables they are indicated to use. Fortunately, with a good wi-fi connection, data can be transmitted at any time. The site staff would need to ensure a good training of the patients so that they comply with the use of wearables and no data goes missing. Surely there will be some regulatory challenges with the virtual clinical trials, but one of the advantages we see is the patient compliance regarding the visits. We all are very busy, have work schedules, have family and kids we want to spend time with, and sometimes making space in our agenda to go to the clinic when the disease in question is not life threatening is quite hard. Collecting information virtually will certainly be an advantage for this patient population.
Another trend this year is the use of artificial intelligence, data processing and data analysis. These are not only gaining popularity in clinical research, but also in other areas of the industry. In clinical research, data analytics is very important. We all have a lot of information, from genetic information of the patients to their activities in the daily life, but we need to integrate and analyze more this type of information. We believe that new trials will be designed to be able to do this when having the data available. This is part also of the “quality by design” approach that we all know from the second revision of the ICH-E6 (R2) Good Clinical Practice guidelines.
Other trends that we are about to see this 2020 in the pharmaceutical industry are personalized medicine trials and combination trials. The use of genetic testing and genetic engineering will let us design trials so that certain patient populations may benefit for treatments. This is related also to the combination of treatments, for example, combining two or more biological drugs, combining drugs with medical devices, etc. Maybe some combination of biologics works on some patient population with certain genetic traits, but doesn’t work on others. All of these combinations will be continued to be explored this year and we believe this is going to a raise.
This year looks to be a very exciting year for the healthcare and clinical industry. We are looking forward to be part of all of these new trends, so that we can contribute ultimately to what is more important: patient safety and wellness. Happy new year! All the best for this 2020.