A recent study has revealed that the global dermatology CRO market has a high growth rate, with clinical dermatology CRO currently capturing the fastest growth avenues. The study also indicates that the leading players are adopting various strategies to increase the market’s overall growth. Some of the factors driving the market are the presence of innovative trial designs and Machine learning-based platforms.
Machine Learning-Based Platforms & Innovative Trial Designs
Machine learning (ML) based platforms and innovative trial designs are expected to transform the dermatology CRO landscape in the next few years. With the advent of more sophisticated health measurement devices and increasing awareness of skin disorders, the dermatology CRO market report is anticipated to experience substantial growth.
ML has the potential to enhance the success of clinical trials through increased precision and generalizability. It can help ensure that the trial design is optimally suited to the stakeholders’ needs. ML can also reduce inefficiencies in the preclinical process.
ML-based predictive analytics can identify potential clinical trial candidates from extensive data points. In addition, real-time patient data can be collected and used to increase the efficacy of new treatment options. Moreover, developing novel digital biomarkers may facilitate the patient-centeredness of clinical trials.
However, despite the promising potential of ML, there are still significant philosophical and operational barriers that limit the full use of ML in clinical research. These barriers must be addressed at each stage of model development and use.
For example, the FDA has stated its willingness to work with sponsors on using ML appropriately in clinical research. However, the agency has yet to determine the proper frequency of model re-evaluation. The optimal frequency will vary depending on the training set and intended application.
Despite the potential benefits of ML for clinical research, it is still considered a high-risk use case. This has led to various pitfalls, which can affect the drug/device development process.
Some of these pitfalls include missteps during the preclinical phase of drug development, which can lead to delayed identification of promising drugs. Another challenge is that if a patient drops out of a study, it can lead to failure to generate valuable data.
Top Players Adopting Different Strategies
The competition in the medical research and development industry is fierce. Aside from the usual suspects, smaller firms may be more interested in researching and developing treatments for rare diseases like ALS or Lyme. Similarly, larger companies may focus on chronic obstructive pulmonary disease and multiple sclerosis. In any case, the competition is good as it forces all involved to improve their game and develop better products.
Several companies have sunk significant resources into improving the patient experience. It is a good idea to keep tabs on these organizations to determine whether or not they are up to speed on the latest clinical trials and clinical management technology. Moreover, a thorough understanding of their operations will allow you to avoid the pitfalls and capitalize on their successes. One way to do this is to keep tabs on their respective medical research and development (R&D) budgets.
Innovative Trial Designs In Dermatology
Innovative trial designs in dermatology are not just confined to the standard randomized clinical trials of old. These include multiple arm designs, enrichment, and even the use of historical control information to reduce the size of trials in rare diseases. The resulting data is also of high quality. It is possible to have an innovative trial design that is both safe and cost-effective. This enables pharmaceutical companies to advance with innovative therapies for skin diseases such as psoriasis, rosacea, and acne.
Using the historical control information correctly can make dermatologic trials much more ethical and cost-effective. One example is the basket trial. A basket trial enrolls patients with multiple drug targets or disease subgroups. With each subgroup randomly assigned to one of two experimental treatments, a corresponding control treatment can be used. As a bonus, the trial is a lot more fun to conduct.
While there are many other innovations in clinical trials, those mentioned earlier should be top of the list. They are the most notable, the best, and the most relevant to dermatology. Other, more minor innovations should be given a pass. For instance, the non-randomized umbrella trial has its perks. Not only can you get more out of a study using this type of design, but you can also use the same experimental treatment with a different set of patients, enabling you to find out which works better without sacrificing a year of patient data.
However, the most crucial innovation in dermatological trials is using an active comparator arm. By reducing the probability that a placebo will be used to test your experimental drugs, you are making a much more potent case for your product. Additionally, this arm allows you to test for noninferiority, the most essential clinically relevant endpoint to test. If your product proves superior to the placebo in an unbiased manner, you have a clear path to successful commercialization.
Another innovative trial design in dermatology is the umbrella trial. Like a basket trial, an umbrella trial enrolls patients with several disease subgroups. Although it is not the most cost-effective option, it can provide a broader perspective on your product’s efficacy. It can also have its own merits and pitfalls. When considering an umbrella trial, you should consider your target population, the design specifications you intend to use, and the budget you have available for conducting the study. Consider using a mixed design, with a few more expensive components in the control arm and a more affordable group of patients for the experimental arm.
The umbrella, as mentioned earlier, the trial was just one of several innovative trial designs that have been demonstrated and tested in recent years. The innovations discussed are all impressive, but it is clear that the most efficient and effective ones are still in the pipeline. Dermatology clinical research is moving in the right direction to improve the safety and effectiveness of new medicines.