Clinical trials are a crucial component of the drug research and clinical intervention development process. To ensure safe and effective clinical outcomes for general use, therapeutic studies are divided into four phases (I, II, III, and IV).
A clinical trial designer experiences several concerns, such as setting up a trial is a challenging process that requires careful planning and project management and needs to anticipate issues that may be faced during the trial supports in a seamless way.
Slow participant recruiting and retention, compliance with standards and guidelines, data administration, and a lack of participant diversity are some of the key challenges researchers encounter. Furthermore, the COVID-19 pandemic has disrupted clinical trials around the world, causing its own set of problems. During the pandemic, several trials were either paused or cancelled entirely, leaving a significant impact on the development of new clinical treatments.
Even though technological innovation has the potential to overcome the issues faced by clinical trials, the industry has been slow to adopt breakthrough technologies. However, using technology in clinical trials is not a new concept, and there have been discussions about how to adopt new developments and their impact on trials for decades.
In recent years, technology supply has risen, while restrictions controlling the use of breakthrough innovations have eased. Concerns about rising costs, increased trial failure rates, and the emergence of patient-centric studies have fuelled a surge in demand for clinical trial technical innovation. Wearable technology, artificial intelligence, big data analytics, synthetic biology, telemedicine, and mobile communication and apps are examples of breakthrough technologies in clinical trials.
There are numerous ways that technology can help with clinical trials. Faster recruitment and retention, improved patient experience, improved patient data gathering, access to non-traditional data sets, and remote patient monitoring are just a few of the benefits. Furthermore, trials can be dispersed, allowing for a more patient-centred approach. Furthermore, revolutionary technology can readily meet the obstacles trials encounter in the new normal imposed on by COVID-19.
Ilse Eder is the CEO and founder of E&E CRO Consulting, which is headquartered in Vienna and focuses on designing and executing clinical studies that are required to launch and bring new healthcare technologies to market. The company has been operating since 1991, and Eder recently sold a majority stake to a healthtech investment firm, Principal Technologies Inc.
Eder notes in this interview that the most innovative, new start-up companies in healthtech often are only able to start out offering their potentially life-saving product in a single market, before expanding globally. To solve this, she believes that multi-centre clinical research studies across many geographies are key.
Tell us about the new trends rising from current clinical trials internationally. What does the future hold for these regulatory pathways?
Recent trends in the clinical trial processes show improvements with streamlining and shortening the whole process. This was probably driven to a large extent by the pressure from COVID-19 and the need for quick results, but there have also been encouraging improvements to the submission and approval process at the FDA in the US, as well as a new centralised process for pharmaceutical trials in Europe established by the EMA. Together, this gives a positive outlook for improved efficiencies across all clinical trials and therefore a faster speed to market for the medical products and pharmaceuticals.
Ilse Eder, CEO and founder of E&E CRO Consulting
Which of these new trends are prevalent in healthcare and how they are shaping the market?
Currently we see more impact of artificial Intelligence (AI) across the industry. It is used in the development of new devices and pharmaceuticals, embedded in new devices, and used in the interpretation of trial results. AI is the most prevalent concept appearing across all parts of clinical trials and it is enabling new personalised treatments.
How have clinical trials changed in their design to better suit requirements of the present age? How have they helped in launching new healthcare technologies to wider markets?
A fairly new change in the clinical trial process is the use of remote monitoring visits that would allow to advance preparation for an on-site visit for faster source data verification. This is currently tested in some geographies; however, others are questioning the risks with data protection. We have to see if this new idea will succeed.
Tell us about your partnership with Principal Technologies.
Principal Technologies has acquired a controlling stake in E&E CRO Consulting to get access to our industry knowledge and early information on upcoming technologies as input to their investment strategies. On their request, we may participate in eventual due diligence assessments to evaluate product technologies of their investment targets.
Healthtech start-ups new to the market can offer their products to a single market before expanding globally, please comment on how this hinders innovation in healthcare and how a mutli-centre clinical research studies across many geographies can be key in solving this?
In my opinion, neither a small and single market study or a large multi-centre study from the beginning are the ideal way to approach global markets. A single market study will restrict you to that market, but a multi-centre study from the beginning exposes you to many risks with unexpected problems with eventual not so qualified clinical sites and so forth.
My suggestion would be to start off with a small clinical trial until the viability of the device or drug is established and the confidence in it has been established. Following this, the clinical trial can be expanded into multiple centers in various geographies and through this approach access to a global market can be provided.