As 2021 goes its course, clinical experimentation for antivirals keeps advancing. The new challenge for the pharmaceutical industry is to provide an efficient and safe way to treat COVID-19.To accomplish this goal, some companies are working on an antiviral at-home pill against coronavirus.
the most expected drugs are Paxlovid, from Pfizer, and Molnupiravir.
Paxlovid has shown to be an effective treatment, because according to an interim analysis of phase ⅔ EPIC-HR Study, the antiviral reduces risk of hospitalization is 89%. According to Pfizer, “it could be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults”. The pharmaceutical company also said that this pill has demonstrated potent antiviral in vitro activity against circulating variants of concern.
On the other hand, Molnupiravir is designed to treat the early stages of the infection, helping reduce hospital occupancy rates especially in places where vaccination rates are still low. This pill can treat issues related to COVID-19 diagnosis and prevent hospitalization; but, most important, it can reduce the risk of death.
Even though preliminary results are promising, there is still a long way to go. The goal now should be to reduce the time in the clinical trial process. Here are a few ways to optimize the clinical trial processes so your formula could be available in the market in less time.
Patient Approach: Involve Them in the Clinical Trial Process
According to Nature, the most important thing to avoid in clinical trials are the delays caused by strategic problems and operational issues. That is why the planning phase is so important. At this stage of the process, the most common stopper is the patient recruitment and retention, so this should be the focus if you want to avoid delays.
To prevent such issues, your company should be aware of the patients’ point of view by creating scenarios in which they can speak up their minds and receive quality responses to their queries. Also, it is important to make the patients feel as a part of the process by having a protocol strictly dedicated to following the concerns they may have.
Use the available technologies to communicate with your patients. Video-calls, for example, are an effective way to make people feel that they are interacting with other human beings and can level up the experience for them, reducing the desertion.
Flexible Clinical Trials: Adapting to COVID-19
Last year, the pharmaceutical industry faced a major stopper: quarantines to prevent the transmission of COVID-19. Closures and travel restrictions were some of the most concerning factors for researchers. Nevertheless, by using the preexisting technology, it was possible not only to go on with the investigation processes, but also to reduce time and resources in clinical trials.
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During these times, the onsite monitoring programs have been migrating to the internet, the clinical trial capsules have been delivered directly to the patients, and the process continues to evolve so it reduces the exposure for researchers and patients alike. Even when there are still problems related to the transmission of COVID-19 —and it’s too early to say that the new ways of testing are successful—, there is hope in terms of safety and efficacy. With this new information, there is an open window for new possibilities in clinical trials in the long term.
New Methods Require the Best Capsule Technology Available
As we previously discussed, remote testing has presented a few more challenges to the researchers. Aside from the logistical problems, the direct manipulation of the clinical trial capsules by the patients requires more strict blinding and encapsulation processes. This is crucial in the development of formulations.
The selection of the capsules required for the clinical trial process can make a significant difference because it can reduce problems related to the patient’s manipulation and the time to market.
Make sure that the capsules you are conducting your clinical trials with are flexible to changes in the API formulation and additives to avoid reprocesses. FM-CAPS® enable fast, efficient color selection, using a reformulation approach and allowing you to leverage earlier-stage clinical stability studies to support your final dosage form format. This innovative method removes wasted efforts in clinical trials, which results in shorter timelines and reduced costs.
Discover more about FM-CAPS®
- Up to 9 months faster to market.
- Reduced regulatory interaction.
- Reduced number of required stability studies.
- Seamless transition from clinical to market capsules.
- Quick color matching & logo designs.