Clinical trials necessitate a detailed approach, with prior indication experience playing a pivotal role. This experience enhances site proficiency, offers valuable protocol insights, and enables effective focused monitoring. These elements collectively contribute to the success of the trial, ensuring that it is designed and conducted in a manner that yields reliable results, ultimately leading to the development of safe and effective treatments.
Expertise Impact on the Site Selection ProcessÂ
Starting with the assertion that experience in a specific indication, such as atopic dermatitis (AD), implies collaboration with various sites nationally or internationally, it is clear that a list of sites demonstrating quality work is readily available. When dealing with unfamiliar sites in a new country, this experience can be beneficial. It facilitates gathering information from public databases or directly from the site, providing an understanding of who will be seeing the patient and what the patient will undergo. This understanding allows for a direct approach to the right person for an accurate assessment of whether the study can be conducted at that site.
However, without a clear understanding of the indication, there is a risk of consulting the wrong doctor. For instance, information was available in public databases about sites that had conducted clinical trials on prostate cancer. Yet, without fully understanding the indication, early-stage patients seen by urologists, and later-stage patients seen by oncologists were not differentiated. Situations have occurred where an oncologist was a PI in the study, but he did not see those patients because he believed they would be referred to him when necessary. However, all the patients at the same hospital were seen by someone else, and none could be included in the trial. Knowledge of the indication can help avoid such situations.
Maintaining Expertise Consistency Throughout the TeamÂ
The secret lies in the strength of a robust, consistent team that has been together for a significant period. The process begins with the selection of the right individuals. Some individuals prefer to switch indications every 2 years, transitioning from one area to another, while others excel at accumulating knowledge and becoming experts in a specific field. Such individuals are desired on the team. Treating them well ensures their longevity within the company. This results in a solid team of individuals with 5â10+ years of experience. Any newcomer to the team can quickly gain a wealth of experience by simply reaching out to colleagues for information about specific assessments, indications, or even the coffee break schedule of a particular doctor they have been trying to contact.
For instance, when dealing with various indications within the same therapeutic area, we develop relationships with investigators. These investigators also see patients with psoriasis, making it relatively easy to learn about new indications through the same doctors. An example outside of dermatology would be trials in neurology, multiple sclerosis and Parkinsonâs. The same doctors that we worked with also saw patients with migraines and epilepsy, which allowed for the gain of substantial knowledge in those indications well before the beginning of the trials.
Indication Experience in Patient Recruitment for Protocol Development
Indero stands out due to its approach to new synopses and proposals, particularly in studies related to psoriasis, alopecia areata, or AD. A team composed of dermatologists, project managers, project directors, and clinical trial managers (CTMs) brings a wealth of experience to these studies. Swift evaluation of the inclusion and exclusion criteria, especially the allowed or prohibited medications, enables an estimation of the recruitment rate. Past experiences allow for quick predictions on whether the recruitment will yield 1 patient a month, half a patient a month, or 3 patients a week.
There are instances where recruitment in the US becomes impossible due to the prevalent use of a particular drug. In such scenarios, consideration shifts to other locations like Germany or Poland, where the drug may not be authorized or, if authorized, may not be reimbursed yet. Such a strategy significantly enhances the ability to predict the duration of the recruitment process.
Translating Indication Knowledge into a Focused Monitoring Strategy
Handling numerous files, particularly in dermatology, leads to a deep understanding of potential pitfalls in a study. For instance, diagnostic criteria can present challenges in comprehension or documentation. Therefore, an early explanation to the clinical research associate (CRA) about potential encounters in patient records, valid and invalid diagnostic criteria, becomes crucial to ensure the recruitment of the right patients. Certain assessments can also pose problems. Education of the CRAs to focus on the proper execution of these assessments, such as tape strips in dermatology, becomes paramount. Incorrect execution of these processes can jeopardize the trial results.
Leveraging the experience of the CRAs and the CTMs, who have spent years in the field, aids in understanding these aspects. Taking into account all the previous experience and lessons learned in dermatology from past trials helps in building a risk-based monitoring plan. This plan outlines the priorities of the CRA when monitoring at the site and what to look for.
Addressing Potential Risks Through Effective Monitoring
Indeed, in dermatology, several unique aspects require proper evaluation from the onset. It is often stated that fire prevention proves more effective than firefighting!
One tool frequently used in dermatology is weighing scales to monitor the progression of patientâs lesions and overall condition. Training individuals becomes crucial, and specific procedures exist for rater training and experience. Despite these measures, raters who have been in the field for many years can become set in their ways and may not fully realize how their ratings have changed. Similarly, new raters who have just completed their training can also deviate from the correct path after some time. Therefore, training the monitors on the scales themselves, showing how scales are calculated and assessed with the patient, and having them undergo training helps identify these issues.
Another important aspect is patient biopsies or, for instance, tape strips. Biopsies often prove uncomfortable for patients, so unless the sites understand the importance of biopsyâwhich is where the role of the CRA comes in to explain its significance for the trial resultsâpatients unwilling to undergo biopsies might be chosen. While it is certainly the patientâs right, it could significantly reduce the scientific value of the study. By focusing on these points from the beginning, fewer problems and much higher quality data can be ensured in the end.
In conclusion, the influence of prior indication experience on clinical trials is indeed significant. It not only bolsters the siteâs proficiency but also enriches the comprehension of the protocol. This leads to more effective monitoring, a crucial element for a successful trial. As the landscape of clinical trials undergoes continuous evolution, the value of such experience remains undiminished. It stands as a critical factor, shaping the future of clinical trials and contributing to their success. This underlines the enduring importance of experience in this ever-evolving field.
Letâs shape the future of research and make a difference in the industry, gain Inderoâs support in your upcoming trial and propel your study to new heights.
About the Author
Jason Shuris, the Chief Business Officer at Indero, is a seasoned executive with over 25 years of experience in the healthcare and life sciences industry. He has held senior leadership roles for more than 11 years at dermatology and ophthalmology-focused Contract Research Organizations (CROs) and has spent 5 years in finance roles at Boston-based biotech companies. Jason holds a bachelor’s degree in business administration and a master’s degree in accountancy. Throughout his career, he has been a key business partner to biotech and pharmaceutical companies, fostering strategic collaborations and partnerships. In his current role at Indero, Jason leverages his vast experience to lead business operations, ensuring the company’s continued success and growth in the competitive healthcare and life sciences sectors.
We are excited to announce that Innovaderm is rebranding our CRO division as Indero (in-dAIR-oh). This rebranding reflects our ongoing commitment to innovation and our expansion into the field of rheumatology, a therapeutic area closely linked to dermatology. As a dual-focus CRO specializing in both dermatology and rheumatology, this strategic decision marks a significant milestone for our organization, and we are eager to embark on this new chapter with our valued partners and clients. Additionally, our Clinical Research Unit (CRU) will keep the name Innovaderm and will continue to conduct dermatology studies.
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