Resources:

• Busdev@innovaderm.com: Use this email to let us know what you want to hear about.
• Art of Protocol Writing
• Dr. Robert Bissonnette and Dr. Kim Papp on Shaping the Future of Clinical Research
• Strategies for Effective Clinical Site Management

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Joining us today is a true trailblazer with more than 25 years of experience in the industry.

We will be exploring the importance of prior indication experience in conducting clinical trials, focusing on three key aspects:

1. Site Proficiency
2. Protocol Insight
3. Focused monitoring

Whether you are a long-time listener or joining us for the first time, get ready to be inspired and informed, let’s extend our warmest welcome to Innovaderm’s Chief Operating Officer, Cedric Burg.

Expertise Impact on the Site Selection Process

To begin, I would like to point out that possessing experience in a specific indication, such as atopic dermatitis (AD), implies that you have already collaborated with various sites nationally or internationally. As a result, you have an immediate list of sites that have previously demonstrated quality work.

The second point to consider is that even when dealing with unfamiliar sites in a new country, having experience with a specific indication can be beneficial. It allows you to gather information from public databases or directly from the site, giving you an understanding of who will be seeing the patient and what the patient will undergo. This knowledge enables you to directly approach the right person for accurate assessment of whether the study can be conducted at that site.

On the other hand, without a clear understanding of the indication, you might end up consulting the wrong doctor. I recall an instance involving a trial on prostate cancer: information was available in public databases about sites that had conducted clinical trials on prostate cancer; however, people would call in a speak to doctors about participating in clinical trials without fully understanding the indication. They did not realize that early-stage patients were seen by urologists, while later-stage patients were seen by oncologists. I have witnessed situations where an oncologist was a PI in the study, but he never really mentioned that 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. Having knowledge of the indication can help avoid situations such as this one.

Maintaining Expertise Consistency Throughout the Team

There is really no secret to that. It all boils down to having a robust, consistent team that has been with you for a considerable period. This begins with selecting the right individuals. Some people prefer to switch indications every two years, moving from one area to another, while others excel at accumulating knowledge and becoming experts in a specific field, gaining knowledge comparable to even surpassing that of doctors in the field. You want such individuals on your team. You want to treat them well to ensure their longevity within the company. This results in a solid team of individuals with 5–10, even 12 years of experience surrounding you. Any newcomer to the team can quickly gain a wealth of experience by simply reaching out to their 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 have relationships with investigators, like in AD. 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 our trials in neurology in multiple sclerosis and Parkinson’s. The same doctors we worked with also saw patients with migraines and epilepsy, which allowed us to gain substantial knowledge in those indications well before the beginning of the trials.

Indication Experience in Patient Recruitment for Protocol Development

What I find remarkable about Innovaderm is the approach to new synopses and proposals, especially when it comes to studies in psoriasis, alopecia areata or AD. The team which includes dermatologists, project managers, project directors, and clinical trial managers (CTMs), has a wealth of experience in these studies. They can swiftly evaluate the inclusion and exclusion criteria, particularly the inclusion and exclusion criteria, particularly the allowed or prohibited medications, to estimate the recruitment rate. Drawing on their past experiences, they can quickly predict whether the recruitment will yield one patient a month, half a patient a month, or 3 patients a week.

In some instances, recruitment in the US may be impossible due to the prevalent use of a particular drug. In such cases, they consider other locations like Germany or Poland, where the drug may not already be authorized or, if authorized, may not be reimbursed just yet. This strategy significantly enhances our ability to predict the duration of the recruitment process.

Translating Indication Knowledge Into a Focused Monitoring Strategy

After handling numerous files, particularly in dermatology, you gain a deep understanding of potential pitfalls in a study. For instance, our diagnostic criteria can be challenging to comprehend or document. Therefore, early explanation to the Clinical Research Associate (CRA) about what they might encounter in patient records, which diagnostic criteria are valid, and which are not, is crucial to ensure we recruit the right patients. Some assessments can also pose problems. Educating the CRAs to ensure they focus on the proper execution of these assessments, such as tape strips in dermatology, is paramount. If done incorrectly, these processes can jeopardize the trial results.

Essentially, you leverage the experience of the CRA and the CTMs, who have spent years in the field, to understand these aspects. You can take into account all the previous experience and lessons learned in dermatology from past trials to build a risk-based monitoring plan. This plan outlines the priorities of the CRA when monitoring at the site and what they should look for.  

Addressing Potential Risks Through Effective Monitoring

Indeed, in dermatology, there are several unique aspects that require proper evaluation from the outset. I often say that fire prevention is a lot more effective than firefighting!

One tool we frequently use in dermatology is weighing scales to monitor progression of patient’s lesions and overall condition. It is crucial to have trained individuals, and there are specific procedures for rater training and experience. However, 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 them how scales are calculated and assessed with the patient, and having them undergo training will help them identify these issues. Another important aspect is patient biopsies or, for instance, tape strips. Biopsies are often uncomfortable for patients, so unless the sites understand the importance of biopsy—which is where the CRA’s role comes in to explain its significance for the trial results—they might choose patients unwilling to undergo biopsies. While it is certainly the patient’s right, it could significantly reduce the scientific value of the study. By focusing on these points from the beginning, we can ensure fewer problems and much higher quality data in the end.

As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.

Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights.

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