What clinical trial organizers should know for 2023
While many trends will be somewhat reminiscent of last year, how they’re being realized has changed, and now, that we have more data to substantiate the impact these are having on clinical trial recruitment. While we believe that the use of technologies, health gadgets, AI and big data will indeed continue to accelerate as organizers gets more aware about their possibilities in speeding up certain clinical trial processes, we also believe that their limits in the next years will increasingly become more clear. In this blog, we explore our top 5 predictions for clinical trials in 2023, while technologies and gadgets can provide a great boost to clinical trials, ultimately the challenge will remain getting enough patients randomized for increasingly complex studies.
Our team of experts with decades of clinical trial experience, explore 5 trends for 2023 that they believe are essential for clinical trial organizers to consider in their plans.
- Achieving patient diversity through better access
- Screening tools are being enhanced to meet complex protocols
- Site burden is here to stay, but it’s being eased
- Decentralized trials: Implementation of technology, big data and AI
Recap of 2022: laying the foundations for 2023
In 2022, the FDA and European medical agencies approved 26 new medications as the annual U.S. Food and Drug Administration (FDA) report of December 2022 highlights. The number of approved medications in 2022 was half that of last year, where 53 new medications were approved, something that can be ascribed to the fact that it’s three years since the start of the COVID-19 pandemic which slowed down or halted many industry operations due to the lockdown.
At the same time, the conclusion by Nature Medicine in early 2022 that this year would be bigger or more successful than before for clinical trials still seems to hold, with the fundament being laid for important breakthroughs in 2023. As BioPharmaDive highlighted, these are technical, for example the trials using CRISPR gene editing in rare disease trials, but also for indications such as Alzheimer’s disease, oncology and small molecule drugs for brain disorders, for example.
Here is what we believe is needed to make 2023 a success for clinical trials:
1) Achieving patient diversity through better access
The NIH Clinical Trial Diversity Act of 2022 (H.R. 7845) the US in June 2022 approved “the first major policy change for equity in clinical research in nearly three decades” as the New England Journal of Medicine noted. This new guidance is undoubtedly a significant step in how the industry addresses inequities in clinical trials by increasing participation of underrepresented populations and ultimately improving the health of more demographics.
While the initial bill is only required for trials funded by the National Institute of Health, Bloomberg law experts deem it likely that in the next years it will become required for any clinical trial in phase III. Considering that the NIH funding has contributed to more than 90% of new approved drugs in past years, the impact of this cannot be overseen. Sponsors going forward would therefore need to provide “clear and measurable goals to recruit and retain clinical trial participants that reflect the race, ethnicity, age, and sex of the patient population”.
Even with all technical gadgets and tools available as well as the staff knowing how to use them, ultimately sponsors still require patients to participate in their trials. It is crucial to consider that patients going forward have high expectations from clinical trials and expect the same level of customer service of what they experience in other services, if not more. This is especially true for digital platforms where across the B2C industry there has been an optimization in usability, customer-friendly information and navigability in the recent years.
Enable better access means providing individual patients with the kind of study participation that they want, in line with personalized medicine more so than on a service level.
To summarize: achieving patient diversity by improving access means making the experience of different groups central in the whole clinical trial process, from outreach to screening, study explanation and ICF-signing, randomization and study follow-up. It means taking concrete steps that enable people from various communities, be it people from ethnic minorities, older adults, pregnant women, obese individuals, LGBTQ+ community, people with existing/multiple chronic conditions (multi-morbidity), and people with severe mental illness to be able to participate in clinical trials by taking measures that enable their participation.
Read more about what measures sponsors can take and how these identity characteristics can overlap in our diversity whitepaper.
Two major lessons from 2022 we as Clariness take into 2023:
- Achieving diversity means group-specific outreach: the COVID-19 crisis has accelerated patients searching health information online (Dr. Google, as some researchers have called it has become the primary way patients search for information). Yet, different communities search for information differently, using various channels and patient communities. It is therefore crucial to take a group-specific approach in digital marketing.
At ClinLife®, we have noticed a stunning 250% increase in influx to our patient portal ClinLife® by patients, caregivers, family members and even HCPs. This shows us that these group-specific outreach approaches and creating personalized access points, in fact work.
- Achieving diversity means improved patient engagement: while reaching a variety of patients is one thing, however the real challenge is providing relevant group-specific educational materials about both the study and place the study in a wider context of clinical research, to build both trust and explain altruistic participation reasons. On our therapeutic area pages on our website (that we continually update with more patient-friendly content tailored), we’ve seen conversion rates increase by 93%.
Furthermore, we have focused on optimizing our newsletters to our database of over 40,000 patients, growing it around 3% every month. We notice that patient-friendly content and engagement leads to 4x higher engagement and referral conversion. This is also highlighted by our enrollment management center reporting a 40% increase in call time last year from patients having questions on the study before becoming a referral.
Therefore, to create diversity in participants it is essential to first create diverse ways for patients to access trials depending on their needs. Or as the Dutch Consultant firm Wolters Kluwer in their recent in-depth report about the pharmaceutical industry concluded:
“Providers will need to be mindful of the need for customized, inclusive educational content for patients in both virtual and traditional healthcare environments. In 2023, expect to see investment in outreach solutions that can deliver more personalized and inclusive educational content that better reflect diversity of patients in age, gender, race, family structure and more.”
Download our whitepaper on diversity, in-depth look at understanding and overcoming barriers to patient participation.
2) Screening tools are being enhanced to meet increasingly complex protocols
Clinical trials are becoming more complex due to a large number of reasons. Firstly, it is based on the therapeutic areas that see most trials started, which in 2022 were oncology and central nervous system (CNS), at 50% and 14% respectively. Secondly, it’s the type of medications used, as Ken Getz, professor and director of the Tufts Center for the Study of Drug Development notes in a recent report:
“What we’re seeing is the consequence of biopharmaceutical companies engaging in more ambitious and customized drug development activity that targets a growing number of rare diseases, stratifies participant subgroups using biomarker and genetic data, and relies on more structured and unstructured patient data from a larger number of sources.”
Thirdly, these complexities are elevated by the specific inclusion and exclusion criteria. These range from a requirement of biomarkers for many oncology trials of which patients themselves might not be aware, or exclusion because of active disease (Crohn’s Disease), as well as hospitalization for heart diseases and criteria to limit placebo response rates in many brain disorder trials.
We notice from our experience that this is also sought for by patients themselves and that especially a phone screener, can provide a better experience and reduce early dropout rates. In the past year we’ve for this reason seen a 40% increase in our enrollment management center call time and follow-ups.
In order limit workload of site staff and also prevent frustration and disappointment for patients who get disqualified at the first on-site screening visit, it is essential for study organizers to make use of a comprehensive two-step pre-screening process. Pre-screening furthermore gives relevant data for sponsors to optimize their study protocols and reflect real world patient data.
The above screener example (taken from our own data) shows that certain inclusion and exclusion criteria for prostate cancer trials lead to a significant available patient population. This then can be used by our sponsors to weigh eligibility criteria against each other, maybe removing a eligibility criterion, if possible, to optimize patient.
3) New recruitment opportunities for rare disease trials
Rare diseases are rare in absolute numbers for a single patient population, but as recent estimates by the World Health Organization and the National Institute of Health show in fact worldwide 1 in 15 people is affected by approximately 7000 rare diseases. This is a big reason for the increasing government attention in both funding and regulatory aid in for example the 2021 US National Policy for Rare Disorders act and last year’s European Joint Programme on Rare Diseases. For 2023 and ahead, market analysts expect the rare market to grow with “12.7% in the forecast period of 2023-2031 as novel therapy launches and approvals are expected to fuel the market growth during the forecast period.”
Rapidly Developing Patient & Site Ecosystem
At Clariness, we’ve seen over 35% growth of rare disease study listings on our ClinLife® platform, which has meant as an organization we have had to move away from using our historic datasets and adapt to partnering with many of the industry’s leading players to expand our own reach to make data-rich and fast decisions on how to best approach these diverse patient groups. We believe that by continuing to build this extensive ecosystem we are able to advance facilitating rare diseases and difficult to reach indications.
Download our rare disease case study to learn how we generated referrals above target for rare diseases such as Multiple myeloma, Bullous Pemphigoid and Sjögren’s syndrome.
4) Site burden is here to stay, yet new technologies are easing it
The shortage of qualified personnel in 2022 impacted almost every part of the global economy. It also severely impacted clinical research, resulting in delayed trials, poor randomization rates and even cancelled trials. A high workload and burnout remains a big factor for turnover rate (32%, twice that of other fields) and 76% of healthcare professionals (including staff at clinical research sites) have reported feelings of burnout and it is likely that this trend will continue into 2023.
Given that the effectiveness of, for example, referral screening only increases after a year of experience, current turnover rates mean that hiring new site staff – 54% of whom statistically leave within 2 years – improving hiring alone won’t solve the site workload problem in 2023.
Therefore, in 2023 sponsors will need to ensure that patient recruitment is performed in a data-driven way, including pre-screening to ensure that only patients who are likely to be eligible are sent to the site. This can have a significant impact on workload, especially during the intensive screening phase. In addition, site staff often need to become familiar with a large number of digital programs, which means that referral management and tracking tools should be intuitive and easy to use, so that new site staff or staff without experience can take over parts of the referral management.
At Clariness we have worked with >7,000 sites across the globe and received a 9 out of 10 Net promoter score from the personnel of these sites, that especially praises our intuitive referral management system. Additionally with our Feasibility service, we help sponsors improve both their patient analysis, site selection and pre-screening.
Download our sites case study for a quick insight in our capabilities to support research sites in the patient recruitment.
5) Decentralized trials: Implementation of technology, big data and AI
Decentralized Clinical Trials (DCT) are also known as “direct-to-participant trials” or “virtual” studies and are characterized by less dependence on traditional research facilities and visits. It naturally accelerated in the COVID-19 crisis, yet its rapid adaption has continued even after the lockdowns and on-site visits became possible again, and will continue in 2023 and onwards.
Two important factors that shape the success of adapting decentralized clinical trials are site staff training and patient satisfaction. While it is true that decentralized clinical trials can make participation in clinical trials much less burdensome and open up participation for minority populations, this is not automatically the case. In fact, decentralized clinical trials may require even more patient-friendly measures to be successful. For example, patients want to be supported throughout the trial, being able to easily access information and certain groups of patients (such as the elderly) may want to have some form of physical contact with the physician throughout the trial.
In order to limit dropout rates and improve diversity, the industry in 2023 and onwards is going to have to better centralize around patients in an ever decentralizing world to ensure that patients do not lose a vital component of clinical research from the patient perspective: the interaction with specialist doctors and a trust and secure environment to receive a new experimental treatment.
Therefore, in 2023, sponsors will need to invest in their ability to ensure the delivery of DCTs. On the one hand, this means adapting the oft-mentioned AI, Big Data analytics and gadgets, but on the other hand, it also means investing in (the in this debate often forgotten) diverse patient needs through creative materials that explain the study process and create understanding of the study in its wider research context, build trust and thereby decide willingness to participate and stay in the study.
At Clariness, we believe that these two components can be combined, as required for decentralized clinical trials. After all, Big Data, AI and gadgets can also play a key role in improving the patient journey. In the last 18 months alone, we have screened one million patients and conducted several in-depth patient surveys with thousands of participants and our data analysis team uses this to optimize both the site optimization, study feasibility analysis and the patient journey. For example, by highlighting improvements in the screening and referral process, thereby limiting patient disappointment through last-minute exclusion on-site. Another example of this is how we incorporate real-world insights into our recruitment process, only approaching patients likely to qualify.
Want to learn more about how we can support your clinical trials with patient recruitment, study feasibility and creatives? Get in touch today.
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