A Pharmaceutical Industry’s Role in Clinical Trial Improvement?
The rush to create a vaccine has brought attention to the process of bringing a medication to market like never before, making it a good opportunity to look at several typical clinical trial bottlenecks.
The drive to quickly develop a vaccine in record time should concentrate attention on common bottlenecks in the clinical trial process, as well as steps that the life sciences industry could take to reduce those bottlenecks and speed up the process for other drug candidates.
One of the primary challenges faced by companies engaged in clinical trials is finding thousands of eligible participants to enroll to gather sufficient data necessary for FDA regulatory approval.
Clinical trial sites, such as doctor’s offices, long-term care homes, and rehabilitation centers, can be integrated into the community to alleviate part of this bottleneck. It would be much easier for trial sponsors to access the patients needed for a particular trial and much more convenient for patients, to participate if there was an exam room, doctors, nurses, and researchers on-site.
This is related to patient access in that trial sponsors must screen participants and determine whether patients meet the trial’s inclusion and exclusion criteria. The process of screening patients is often labor-intensive, manual, and slow. It involves making phone calls, leaving messages, setting up in-person meetings, and conducting screening interviews, all of which add time and cost to the process of developing new drugs.
More clinical research organizations and pharmaceutical companies are using artificial intelligence for patient screening to address the problems. AI tools are used to guide patients through sessions based on the trial’s inclusion and exclusion criteria after they respond to trial advertisements. The AI program arranges for the patient to visit the study’s location to have additional discussions with clinicians if the patient is pre-qualified.
There is a concerning lack of knowledge about clinical trials among the public, not to mention when and how patients can benefit from trials. Sponsors and CROs should think about organizing public education events in the areas where clinical trials are being conducted to increase public knowledge of these studies.
Many smaller medical practices lack the necessary infrastructure, such as staff members who are trained on informed consent and working with research ethics. To overcome these barriers, sponsors, and CROs can bring the tools and expertise needed to support community physician engagement.
One must incorporate sizable sample sizes from a wide range of racial backgrounds because racial and ethnic differences greatly influence how individuals respond to medications. Hopefully, by raising awareness among patient populations and physician organizations, the diversity of patients’ racial and ethnic backgrounds will eventually show up. There are many ways that the clinical trial process could be improved, it’s important to keep in mind that trials frequently give patients access to treatments that could change their lives but which they would not otherwise have. The pandemic has brought to light the importance of streamlining the clinical trial procedure for the sake of human health in the future.
