Clinical trials: 2021 Recap and take-aways for 2022 and ahead. From vaccine trials, new regulations, decentralized trials and patient-centricity

As 2021 draws to a close, it is time to draw conclusions and look ahead. For clinical research as well as for us at Clariness personally, it has been a challenging but also exciting year. On the one hand, the release of several COVID-19 vaccines and medications, which have greatly reduced the number of severe hospitalizations, has undoubtedly had a positive impact on public opinion about clinical research. Recent surveys show that confidence in research has increased by 80 % compared to the pre-pandemic period.[1] On the other hand, the uncertainty of the pandemic continues to be reflected in delays in trials, changing regulations in social media marketing and competition between organizers for similar indications for study-participants, which means a constant challenge to adapt to new situations.

In this blog, we will present the 4 most important insights from 2021 for 2022, based on trends, observations from expert and our partners as well as our own experience.

Let us know what you find the most interesting trends in 2021 or if you think we missed anything that you would like to  see to covered by our experts in a future blog.

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Our top 4 of take-aways from 2021 for 2022:

  1. Rise of vaccine trials and making them a success
  2. Patient-centricity & trust in research
  3. Digitalization and decentralized trials
  4. Changing regulations and data security

1: Vaccine trials and making them a success

Where early in the year the introduction of the vaccines raised the hope that the pandemic would soon be over, in the last months owe again faced the reality that it might last longer. In clinical research big names as Astrazeneca, Pfizer, Moderna and Johnson & Johnson already early in 2021 began booster vaccination studies  and clinical trials for new vaccines, therapies and medications for COVID-19 only increased throughout the year. Data from the WHO’s Covid-19 Candidate Vaccine Landscape and Tracker show that currently there are over 180 clinical trials for 80 coronavirus vaccines underway, and it is clear that these effort will continue in 2022.[2]

For pharmaceutical companies, university hospitals, research institutes and sites planning, organizing and conducting clinical trials for vaccines, this means there is an increasing challenge and competition to find participants. As clinical trials for vaccines are usually without strict inclusion and exclusion criteria and open to the general population, there are some general lessons from 2021 for vaccine trials (that are often also applicable to studies for other indications) going forward into 2022[3]:

  1. Recruitment for (vaccination) studies require a shift in public understanding of vaccines or the respective indication: as Collins argues, vaccination is traditionally associated with children, making adults sometimes skeptical to recruitment for adult-only vaccine studies. This requires that patient recruitment is backed-up by lay-information campaigns with about the working, possible side-effects and community benefits of vaccination.
  2. Community engagement and locally-adjusted outreach effort are essential: vaccine studies require locally specified outreach campaigns ranging from targeting only people in the close proximity of the study center who are likely to participate, to involving local health workers and community groups to understand “social groups and tailor vaccination strategies to their needs”.
  3. Cultural and linguistic adaptation of recruitment materials and strategies to key groups: understanding the concerns and addressing these in easily understood, readable or video-style information (for illiterate) could improve recruitment in elderly and minority populations.[1]
  4. Clear explanation of the possibility to receive either the candidate vaccine or placebo: as almost all studies highlight that the willingness to participate in vaccine trials is mostly based on receiving the vaccine. To reduce dropout rates, potential participants should be helped to understand why a placebo is methodologically necessary and for example have the prospect of receiving the vaccine after study completion.[2]
  5. Willingness-to-participate significantly depends on required study center visits: while study visits are crucial for example for doing blood tests, frequent study visits over often lead to a significant drop in willingness to participate. Information or allowing remote visits could help making participation more easy.

[1] Hussain-Gambles M., Atkin K., Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc. Care Community. 2004;12(5):382–388.


[1] Hussain-Gambles M., Atkin K., Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc. Care Community. 2004;12(5):382–388.


Woman receiving a COVID-19 vaccination
In 2020 and 2021 Clariness has supported serveral global clinical trials for COVID-19 and long COVID-19 syndrome

Clariness’ take on Vaccine Trials recruitment for 2022:

In 2021, we have supported the enrollment of various clinical trials for vaccines from Yellow Fever vaccines to COVID-19 Booster Vaccine trials. Despite the fact that COVID-19 vaccines were already widely and freely available in Germany, we managed to refer over 136 people to the single site, of whom at least 57 were successfully randomized. For a yellow fever vaccine study, we successfully helped a site achieve 62 randomizations with a similar digital but locally adjusted outreach campaign.

In our experience, a combination of digital channels for patient engagement can achieve the above results and successfully reach, inform and enroll participants for vaccine trials.

Because studies show that people participate in vaccine trials primarily to receive the vaccine, continuous study visits (after receiving the vaccine or placebo at the first visit) are a barrier to successful recruitment and retention. Therefore, visits need to be made as easy as possible, and focusing on participants that live near a research center (and providing study visit reminder services and travel compensation) has been shown to result in fewer study dropouts and, most importantly, more satisfied participants.

Our method of digital patient outreach additionally identifies people who are likely willing to participate and qualify based on online behavior as search behavior, interests other study population characteristics. This in combination with our ClinLife® platform making patient-friendly study information, benefits and general information about the vaccine easily accessible and shareable, have shown us that participation for many depends on a better understanding of the importance of clinical trials for vaccine development. This also improves willingness to participate despite the ‘risk’ of receiving a placebo.

Our lesson for 2022 is that improved digital patient engagement and community engagement can lead to higher participation rates and better patient retention, even when there is no direct monetary benefit in return for participation in for example vaccine trials.

2: Patient trust in clinical trials comes from good patient-centric communication

The start of the COVID-19 pandemic in 2019 brought scientists and clinical research to the center of public attention. As a direct consequence, trust levels have risen substantially worldwide and as recent overviews show these remarkably have improved the strongest among people who said they knew “some,” “not much” or “nothing at all” about clinical science and medicine. As Beth Thompson, authors of the survey, note these ‘results may surprise those who monitor the surge of misinformation and skepticism towards the COVID-19 vaccines.

At the same time it is crucial to understand that trust is short-lived, easily lost and context dependent, meaning that clinical trial recruitment campaigns in 2022 will continue to depend on information and trust-building efforts. In a recent New York Times article Fatima Tokhmafshan, geneticist and leading science communicator of the COVID-19 response in Canada, suggested that outreach campaigns for clinical trials should have a dedicated approach for different study populations. Especially for addressing minority groups, scientists according to her could do more to:

“[…] elevate the voices of scientists from marginalized groups, as well as increase outreach to underserved communities that might harbor historical mistrust in medical institutions. Representation and equity is very, very important for building trust” – Fatima Tokhmafshan.

Not directly related to trust, but nevertheless a new transformative component of patient-centricity in 2021 are the so-called Expanded Access programs (also called Compassionate Use Programs). In these programs, that were increasingly adapted in 2021 and likely will expand in 2022, patients who don’t directly meet the inclusion or exclusion criteria due to comorbidities or other factors still get access to the study medication. This by for example creating separate subgroups who are not part of the main study analysis. While the data that these subgroups provide is not directly contributing to the main analysis, it can still be important and valuable data later on and create trust for making medication accessible to non-standard patient populations.

Clariness’ take on patient-centric recruitment in 2022:

For the 6th year in a row, 2022 for Clariness will start with the Patient’s Voice conference where we invite researchers and clinical trial organizers to come and listen to former study participants about their experiences.[6] For us Patient’s Voice is a great motivation and incentive to understand at the start of the year that our focus is on what patients need and want and how we can help them have that.

In 2021, we incorporated many of this and previous year’s Patient’s Voice participants suggestions in the launch of our patient-centric clinical trial database. We are proud to have received further support from the European Investment Fund, which stated in its award that ClinLife® ‘patients worldwide being able to find relevant clinical trials for their medical condition.’ By the end of the year, ClinLife® Registry with Boehringer Ingelheim expanded to Poland.

Although our creative team in 2021 has already made all study descriptions and study explanations available in the relevant local languages, the year 2022 will be marked by additional efforts to provide patient-oriented information and build trust. Two examples:

Information videos will also become more important in 2022. To reach patients who want to learn about studies but have difficulty reading, videos are a good option. For us, its importance and success is clear: our in-depth interview with a lung cancer expert Prof. Dr. med. Wolfgang Schütte received over 2400 views and our video explaining a Diabetes Type 2-trial received almost 400.000 views.

Interested? About our Creatives and Patient Retention services

Retention of study participants is essential for the timely completion of any study. Our Creatives & Retention team motivates and keeps patients engaged. Lay-friendly study materials in local languages help patients understand the study in the wider context of clinical research.

3. Decentralized trials and digitalization

If there is one new trend in clinical trials that has defined 2021 and will continue to grow in 2022 it is decentralized trials. A recent global surveys by GlobalData show that nearly 70% of all clinical trial organizers, both governmental as industry funded, plan to use or partly switch to decentralized clinical trials in the following years.[8] For Hybrid Trials (trials that replace some study center visits with telephone or video calls) this trend is even stronger, with some surveys showing that up to 80% of all big pharmaceutical sponsors already conducted one Hybrid trial in 2021, with almost all clinical trials in 2022 and onwards likely switching to Hybrid models.

The  biggest advantages of Decentralized Trials are:

  1. Improved patient recruitment and retention due to limited or no compulsory site visits: as required visits (and travel distance) are one of the biggest reasons for people to decide against participation or for dropping-out later, limiting visits is a big facilitator of participation.
  2. Increased diversity in study population: studies show that the participation of minority populations, elderly people and people from lower social-economic backgrounds are especially impacted by travel distances and frequent visits. Decentralized Trials make clinical research accessible to a more diverse audience (that first still needs to be reached).

An essential prerequisite for the successful implementation of decentralised and hybrid clinical trials is digitalisation. The digitalisation of clinical trials comprises various elements, from the digitalisation of patient recruitment, information, pre-screening to online study visits and secure access to patient data and ensuring data protection.

With the increasing digitization of all aspects of clinical trials, there has also been a rapid increase in digital solutions, apps and technical devices to support clinical research and patients. These apps support patient engagement by, for example, scheduling reminders for visits, analyzing study feasibility and providing various services for patients.

Clariness’ take on decentralized clinical trials in 2022:

Over the past two years, we have successfully supported an array of decentralized clinical trials. While we share the optimism of clinical trial organizers, we also know that decentralized trials require a strong focus on organization and information provision to make them patient-centered and improve patient retention and satisfaction. We are also anticipating what 2022 will bring in terms of a new type of flexible or dynamic study design that will give participants even more flexibility, such as the ability to move between different research centers nearby and conduct even small tests at home.

“A record number of around 1,300 trials with a decentralised and/or virtual component will likely initiate in 2022, representing a 28% increase from 2021.”

As we highlighted in our recent analysis of Decentralized Trials and patient-centricity: ‘DCTs are the culmination of a trend towards patient-centricity; designing clinical trials based on patient needs, indication, and therapy’. Done right, ‘DCTs take the trial to the patient, instead of the patient to the site.’ In a recent interview we conducted for our patient blog, Dr. Laura Blauth, organizer of a Clariness supported decentralized music therapy trial for dementia, also mentioned that one risk of Decentralized Trials is that researchers and patients lose touch and that digital information provision before, during and after the study is crucial.

We believe that for 2022 it is even more important for Decentralized Trials to inform potential participants and provide patient-centric content in order to successfully enroll participants while at the same time keeping retention high. More so, as more and more people are concerned about their online data security and new regulations are introduced, researchers and trial staff need to access patient and referral data in a secure and GDPR-compliant environment. For this reason we have expended our Investigator Service, where our partners in a secure and GDPR-compliant portal can easily check new referral data, manage patient status and contact new potential participants. Our new Investigator Service more so is easily used without extensive training, especially compared to other

As we explained in our decentralized trials and patient-centricity blog: “with less physical sites, patients still require regular engagement. We, therefore, work closely with research centers and support them with patient engagement and retention by regularly communicating with patients, providing materials for patients to read and stay informed, and being available to patients as needed.”

4. Changing regulations and patient outreach

The year 2021 continued to see a rapid succession of regulatory changes by governments, social media platforms and health authorities. These changes, and in particular the speed with which they followed one another, have had a major impact on clinical trials and once again underlined the need to change quickly and adapt to new situations.

The FDA’s June 2021 guidance has allowed clinical trial organisers to use digital innovations that have proven successful in pandemic and COVID-19-related trials for other studies. The 2019 FDA diversity guidance also still has implications for clinical trials, as more patient organisations are calling for the implementation of patient-centricity and trial organisers are looking for different ways to achieve this.

At the same time, regulatory and privacy policy changes by social media as Facebook and Instagram in the wake of the data protection scandals have made it more difficult to select and target potential participants through digital outreach campaigns. Therefore, clinical trial recruitment campaigns need to rely more on their own data sets that can be used to define potential study populations.

Patient databases and patient organization partnerships will continue to gain importance in 2022 , as social media marketing is expected to become more expensive, and more advertisers target the same user.

eConsent, or the use of electronic methods to obtain informed consent from participants, is also a trend from 2021 that is likely to continue into 2022. Although the FDA and the US Office for Human Research Protections (OHRP) have allowed the use of eConsent since mid-2016, clinical trial leaders have largely not adopted it yet.

Similarly, online methods for pre-selecting potential participants will become increasingly important in 2022 as site staff are overworked and patient-centricity efforts will focus on providing clarity and avoiding disappointment for potential study participants.

Clariness’ take on regulatory changes & big data in 2022:

With the increasing importance of GDPR and data security and privacy compliance among both the public and regulators, in 2021 we focused on going a step beyond what is necessary with our new Investigator Service. This service allows study center staff to easily manage and contact referrals in a secure, GDPR-compliant and easy-to-use environment.

Secondly, our Clinlytics and Patient Survey team has expanded and put additional focus on mapping and understanding various local patient populations. The understanding of various patient populations characteristics and needs allows us for a better digital patient-centric outreach effort.

We then use this data in combination with qualitative studies and surveys to identify patients who are likely to be eligible for each study (based on location, search interests and age) and define our pre-screening and matching service. This saves frustration and disappointment for people who would otherwise only be rejected at the on-site screening and reduces the workload of our partner sites.

We have also taken further steps to provide our more than 1.6 million registered users with up-to-date information on clinical research and to inform them when new studies are available on our ClinLife® portal. For some new studies, up to 40% of the referrals we contribute come directly from our own patient database. Expanding our database and making it easier for patients to find, inform themselves and sign-up, therefore is also a focus for 2022.

6. On Clariness

We offer a range of services to help you accelerate your clinical trials and bring medicines to market faster. We believe in local expertise with global reach.

Our services:

Study feasibilityFrom protocol design to study site selection: understanding your study’s target population is critical. With the help of our Clinlytics technology and Patient Insights surveys, you base your study design on facts and data.
Digital patient recruitmentThe ClinLife® portal with over 1.6 million registered users and 15 million annual visitors is designed around patients needs. Take it as a long-term subscription model (ClinLife® Registry) or use it on a project basis (Active Recruitment), for large, international studies or those towards the end of recruitment.
Patient engagement and retention  Retention of study participants is essential for the timely completion of any study. Our Creatives & Retention team motivates and keeps patients engaged. Lay-friendly study materials in local languages help patients understand the study in the broader context of clinical research.

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[3] Collins J, Westerveld R, Nelson KA, Rohan H, Bower H, Lazenby S, Ikilezi G, Bartlein R, Bausch DG, Kennedy DS. ‘Learn from the lessons and don’t forget them’: identifying transferable lessons for COVID-19 from meningitis A, yellow fever and Ebola virus disease vaccination campaigns. BMJ Glob Health. 2021 Sep;6(9):e006951. doi: 10.1136/bmjgh-2021-006951. PMID: 34535490; PMCID: PMC8450956.

[4] Hussain-Gambles M., Atkin K., Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc. Care Community. 2004;12(5):382–388.





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