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Traditional clinical trials can be lengthy and are often a burden for patients involved. Patient recruitment is a major contributor to study delays and, thus, dragged-out drug development timelines. In response, we are seeing the rise of decentralised clinical trials (DCTs) – clinical trials that offer effective digital patient recruitment through digitalisation and a smooth journey for the patients throughout the study period. Coegin Pharma is a prime example of a pharma company taking advantage of DCTs through its collaboration with Studies&Me, an innovative virtual contract research organisation (CRO) based in Denmark. BioStock takes a closer look.

Bringing a new drug to market is a time-consuming and costly process. The journey from drug discovery to market approval takes several years, even decades in some cases, of dedicated work and involves high levels of risk. Furthermore, on average, it costs 2.6 BUSD to develop a new drug. Read more about the challenges related to drug development here.

A majority of the costs in both time and money are attributable to delays in the clinical testing phase of drug development. In fact, patient recruitment is the single biggest cause of clinical trial delays. According to one study, 30 per cent of phase III study terminations are due to enrolment difficulties. Additionally, approximately 80 percent of trials fail to meet the initial enrolment target and timeline. 

The rise of decentralised clinical trials (DCTs)

Much of the trouble with patient recruitment boils down to convenience for the patient; trial participants recruited in traditional clinical studies are typically those living close to a trial site, as patients living far away will likely hesitate to participate. This creates a lack of heterogeneity in patient population that would more closely mirror the end user patient population.

One of the solutions to the problem has been the digitalisation of the patient recruitment and interaction process. Thanks to social media and apps specifically made for clinical trial purposes, patients have become keener to participate in clinical trials, thus leading to faster recruitment of specific subpopulations for trials with narrow indication due to a larger potential participant pool being present.

Studies&Me

More and more contract research organisations (CROs) are adopting a decentralised approach to clinical trials, where digitalisation plays a major role in dealing with patients. In Denmark, Studies&Me, the first virtual CRO in Europe, is a great example. With a strong legacy in pharma and health technologies, Studies&Me’s goal is to personalise treatment development through digitisation across all stages of clinical development, from recruitment to trial completion.

Since its founding in 2016, the CRO has explored, tested, and validated new methods for conducting smarter, faster, and more accessible clinical trials by tapping into the unmet potential of emerging technologies and ever-expanding volumes of digital data within clinical development. For example, Studies&Me conducts studies with a bringing your own device approach, which means that study participants download and use a study app,developed by Studies&Me to their own smartphone. This allows for easy access to the study, while also giving patients more peace of mind, resulting in lower dropout rates.

»The project Studies&Me was founded to bring a patient centric approach to clinical research, from recruiting to trial execution. Today we are an independent company, showcased through 5000+ patients and 25 studies. Since the beginning, we have been focusing on personalising treatment development to effectively fit clinical trials into the everyday lives of patients« — John Zibert, CEO for Studies&Me

Coegin Pharma collaborates with Studies&Me

One of the companies taking advantage of Studies&Me’s services is Coegin Pharma, a Nordic pharma company developing a treatment for Actinic keratosis (AK), a very common pre-cancerous skin disorder. The company’s main drug candidate is AVX001, a compound that targets the cPLA₂α enzyme, which is involved in a variety of inflammatory diseases, including several cancers, as well as pre-cancerous conditions like AK. Read more about Coegin Pharma and its vision here.

Coegin Pharma is currently planning a phase I/II trial with AVX001 for treating AK patients in collaboration with Studies&Me and Bispebjerg Hospital. An application for clinical trials (CTA) to the Danish Medicines Agency and to the Scientific Ethics Committee has been recently submitted and a response from the committees is expected by summer.

The double-blind, placebo-controlled, combined study will be led by Professor Merete Hædersdal (MD, PhD, DMSc) at Bispebjerg Hospital. BioStock was able to interview Professor Haedersdal to learn more about the clinical trial, and that interview can be found here. The study is expected to begin (pending approval) in August 2021 and results presented in early 2022.

An inside look into the collaboration between Studies&Me and Coegin Pharma

BioStock was able to get in touch with the CEO of Studies&Me John Zibert as well as the CEO of Coegin Pharma Tore Duvold to learn more about the benefits as well as some of the challenges of DCTs and how the collaboration between the two companies will benefit patients.

»Our decentralised setup has the advantage that the patients are supported in their homes and only a few visits to the hospital are required. We do not expect a negative impact of the study due to the pandemic« — Tore Duvold, CEO of Coegin Pharma

John Zibert, could you tell us more about how Studies&Me was born?

– Studies&Me was initially established as a project within the digital innovation unit, LEO Innovation Lab, under R&D at LEO Pharma in 2015, with the grand wish to innovate with digital tools for the benefit of improving the life quality of patients. The project Studies&Me was founded to bring a patient centric approach to clinical research, from recruiting to trial execution. Today we are an independent company, showcased through 5000+ patients and 25 studies. Since the beginning, we have been focusing on personalising treatment development to effectively fit clinical trials into the everyday lives of patients.

John Zibert, CEO of Studies&Me

What are some of the key benefits of running a DCT through Studies&Me?

 – We constantly have to motivate the patients and the healthcare personnel (HCP) involved in the trial. This can be done by making it easier for patients to engage in the study and by giving HCPs easy access to the study data. We make that happen through our decentralised study design. From a sponsor perspective one advantage is that we can take care of all parts of the trial from protocol writing, to patient recruitment, to trial completion. Furthermore, we do ensure that many more patients will have access to the trial, due to the remote setup that allows us to reach and engage patients who are based far from the study sites.

And how about the challenges?

– Decentralised trials are of a new design that differs significantly from the traditional way of conducting trials. The new approach therefore requires a different level of understanding from ethical committees and regulatory bodies with regards to ensuring the safety of patients throughout the trial. In our experience, patients and HCPs really like this new approach as patients constantly feel involved in the trial and HCPs can obtain a constant overview of their patients’ data and study activities. This allows an even larger level of monitoring, and hence real-time control, ensuring the safety of the patients.

Does the pandemic have any impact at all on how these DCTs are run?

– The pandemic has not changed the way we run DCTs, it has only underlined the need for digitising as many parts of clinical trials as possible so that trials are not slowed down by society closing down in relation to a pandemic like COVID.

Tore Duvold, how did you find Studies&Me, and why did you choose them to help run the AVX001 clinical trial?

Tore Duvold, CEOof Coegin Pharma

– I have followed Studies&Me from the very beginning, and I had a deep understanding of their unique capabilities. I have had a long career at LEO Pharma, both as a scientist and as an executive, where I worked closely with John Zibert. I admire his talent and his knowledge in actinic keratosis is certainly important for us. The rest of the team has also impressed me. 

How many patients do you plan on recruiting for the study and are you confident the recruitment process will go quickly and smoothly, despite the pandemic? 

–We plan to recruit more than sixty patients for the trial, and we expect to complete the recruitment in only a couple of weeks which is quite impressive. Our decentralised setup has the advantage that the patients are supported in their homes and only a few visits to the hospital are required. We do not expect a negative impact of the study due to the pandemic. 

Finally, overall, how much more value is added to Coegin’s vision by collaborating with a virtual CRO like Studies&Me?

– The obvious parameters are that we can go much faster. However, I believe the most important factor is that it will be a far better journey for the patients participating in the trial. Finally, I also believe that the quality of the trial is better when patents are engaged and monitored more frequently as compared with a traditional trial.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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