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As the clinical trial recruitment landscape continues to evolve, patient recruitment remains a critical challenge. More innovative screening strategies can improve recruitment and enhance the quality of clinical research.

Better Qualification Strategies, Better Patient Recruitment Outcomes

Webinar Date/Time: Thu, Oct 24, 2024 1:00 PM EDT

Optimizing Centralized Patient Recruitment for both Sponsor and Site Success

Webinar Date/Time: Tue, Aug 20, 2024 11:00 AM EDT

Three Essential Elements of Meeting Patient Enrollment Goals on Time and on Budget

Increased interest in cell and gene therapies has led to increased demand for expertise to help sponsors, CROs, and sites coordinate human gene transfer (HGT) research. Compared to clinical trials with older, more traditional classes of drug products, there are important similarities and differences in requirements for safe and ethical conduct of clinical trials of gene therapy and related modalities.

Transforming Research: The Intersection of Ethics, Biosafety, and Innovation

In an interview with Nico Saraceno at DPHARM 2024, Munther Baara, VP strategy and innovation, EDETEK touches on the features an effective AI/ML model can provide and how they benefit data management in trials.

DPHARM 2024: Developing AI/ML Models for Clinical Trials

ACT: You have an upcoming session on “Transforming Clinical Trials: From Reactive to Predictive.” What are some of the main points that will be discussed during the session?

 I'll be talking about the metaphor of travelers. Back in the days—it depends how old you are—you might remember when people used to travel, they'll have a map with them. There'll be a passenger next to them with the highlighter trying to map their route, and if they miss an exit, it will probably take them another hour to come back and then we progressed to the MapQuest, where we printed the map, and then we end up with the GPS, and then we end up with a smartphone, and then became a gamification with ways and now we're getting into the predictive analytics to basically predict how you get to do your next day and probably telling you what you should be doing, etc. I see this like in our clinical trials, there's some companies that are still using the paper, navigating with the highlighter, there's people at the GPS, and once a new study with different endpoints, it becomes harder and harder for them, basically, to navigate and be able to see the big picture.

What I'm going to talk about is very simple concept. We call it the four Cs—connect, collect, conform, and consume. What we've done, we’ve built this whole architecture to allow you to connect to the different data providers at the site level or at the study level, so that gives you the ultimate flexibility. You could use different ADC vendors, central labs, ePRO, new digital endpoints, genomics, data, etc., it doesn't matter. The idea behind it is those data providers will immediately be basically pushing data into what we call our digital data pipeline. Then, once the data starts flowing in, you'll see the data coming in and then conforming to the standard of your liking, whether it's for submission or for data review, and then provide you the final piece, which is what we call the consume piece. That's what's so powerful, because now you have to think about it like, you come to a building, you expect light, electricity, and water, right? You don't think about it. Once we do these hooks into the building, into your clinical trial, into our digital data pipeline, things start flowing, and now you're seeing everything in one place, one version of the truth. There are no delays because typically study managers tell me my study was great—green for six, nine months, the first DMC data monitoring committee meeting, I need to do the cleanup or interim analysis—that's when things start basically going south. It went immediately from yellow to red, and I see I have the wrong patients in the study, etc. We solve this problem from day one. That's the key. Study starts. Data starts flowing in. You're seeing whether you are enrolling the right patients into the study or not.

ACT: From a technological standpoint, what’s required for the development of more accurate AI/ML models?

 That's a good question. I struggle a lot of the time when people talk about AI and machine learning, and I feel like they have not done the foundational pieces that's needed in place. Of course, you need AI and modeling and machine learning, but you’ve got to think about: you need to be able to curate the data, aggregate the data, and you need to make sure the data is validated with high quality, so not only curate, but cleansing of the data. The 4 Cs concept that I described does exactly that because we bring data in real time, we basically run all these validation checks, and we have what we call flexible validation rules that you can do through and point and click. Zero programming involved. It eliminates SAS coding, et cetera, especially when you cross data across different data providers. I can look, for example, like somebody says in the exposure data, we adjusted the treatment, and then I look in adverse events, there is no reason for adjustment, et cetera. I can basically cross reference a lot of data. I can cross reference lab collection with the actual lab results, the ePRO data, with how the patient reported safety versus SAE, so I can do that all in coding and then we can apply algorithms as well to monitor the quality of the data. As the data comes in, you immediately point out where there's weak points or what needs to be addressed and tackled, and you’re cleaning the data as you go. That gives you the foundation to have excellent AI and machine learning, basically models in place in order to respond to this. Without it, your model is going to be weak. You're going to be missing a lot of pieces, and not only that—which I forgot to talk about—is the metadata about the data. In order for machine learning and AI to increase the accuracy of it, you need to have the data about the data and that's what our platform has. We can take raw data, transform it to any target data, like from the ADC collection to the SDTM, CDISC, and SDTM format that's ready for submission for the regulatory agencies, so that together is needed in order to be able really to get into the next level.

Latest Conference Coverage

To date, there is limited insight into the perspectives on eConsent in clinical trials of Independent Ethics Committees/Institutional Review Boards, collectively referred to as Ethics Committees (ECs) in this article, as well as into the opportunities and barriers faced by sponsors (commercial, non-commercial) and vendors (technology companies, CROs). The European Forum for Good Clinical Practice (EFGCP) eConsent initiative, comprised of over 50 companies, has conducted two surveys to gain a comprehensive understanding into behind-the-scenes perspectives of ECs and sponsors/vendors. This article represents the key findings of both surveys and detailed results can be accessed through the supplemental information section. 

The importance of the right understanding about eConsent

A correct and aligned understanding of eConsent is crucial to ensure that all stakeholders are on the same page. For this purpose, the EFGCP eConsent initiative has developed a comprehensive glossary of eConsent terms including over 60 harmonized eConsent platform and operational aspects. This resource equips stakeholders with a unified language and the necessary knowledge and terminology.

 The glossary was incorporated in the introduction of both surveys.

To recap, ‘eConsent’ is an overarching term used to represent the traditional informed consent process, supported by one or more digital features.

 A visual representation of this eConsent definition and some examples of digital features are shown in Figure 1. There are many different eConsent models, there is no one-size-fits-all eConsent model. Each study, each indication, each site, and each participant might have its own needs and requirements.

1. EC eConsent survey respondents characteristics

49 EC respondents from 15 different countries completed the EC survey of which 53% were from Europe, and the rest were divided between Russia (20%), North America (18%), and Malaysia (8%), as shown in Figure 2.

The level of experience with eConsent was variable:

61% had reviewed and approved/rejected eConsent.

35% had never been asked to approve eConsent

A substantial proportion of ECs respondents had previously been asked to approve eConsent in North America (78%), in Malaysia (75%), and in Europe (65%). In contrast, only 30% of Russian EC respondents have been asked to approve eConsent.

2. Preserving human Interaction with eConsent: The most important factor for ECs

The most important driving factor for EC respondents (43%) to approve eConsent was preserving the interaction between investigator and participant.

Participant-investigator interaction is a foundational Good Clinical Practice (GCP) of informed consent.

 In addition, while some Health Authority guidelines (e.g. EMA) recommend a physical interaction, a remote interaction can also be justified in some cases, opening alternative modalities for this investigator-participant interaction.

EC respondents further scored patient-centricity (22%) and regulatory acceptance (18%) as important driving factors to approve eConsent. Of relatively smaller relevance for EC respondents was the knowledge that eConsent is accounted for in site guidance documents (2%), that there is an easy access to technology, training and documentation (2%), and that it enables decentralized trials (2%).

3. eSignatures acceptability by ECs: Various factors play a role

The interpretation of eSignature terminology varies greatly across the globe. A handwritten signature drawn by finger or stylus on an electronic device is considered an eSignature according to European eIDAS regulations, but NOT according to FDA regulations. Hence, we recommend describing the signature process in detail to ensure it is clear for all stakeholders.

 In the surveys, we used the eIDAS eSignature terminologies: Simple eSignature, Advanced eSignature, and Qualified eSignature.

The EC survey results showed that eSignature requirements became more stringent when moving from on-site workflows to remote workflows conducted via televisit or via phone call.

As illustrated in Figure 3, an eIDAS Simple eSignature was acceptable:

for Phase I-III interventional studies by

47% of EC respondents when eConsent was conducted on-site

11% of EC respondents when conducted remotely via televisit

7% of EC respondents when conducted remotely via phone call

Regional difference existed with an eIDAS Simple eSignature on-site being acceptable by 53% of European EC respondents versus 33% of North American EC respondents, and 13% of European EC respondents requiring a wet-ink signature versus 22% of North American respondents. More details can be accessed through the supplemental information section.

4. Offering both paper and eConsent: A key recommendation of ECs

The EC survey posed a forward-looking question to gauge the sentiment on providing consent only electronically. 61% of EC respondents did not agree with this. North American EC respondents had the highest score (78%), followed by European (65%), and Russian EC respondents (60%). On the contrary, Malaysia seemed to be more supportive for providing consent only electronically with 75% agreement. The emphasis on patient-driven choices and diversity and inclusion without additional biases is presumed to be driving the results. Providing options for participants and sites is important to avoid creating a new diversity barrier for participant populations that lack basic digital literacy skills.

5. The site: Preferred location to store personal data for ECs

When it comes to data storage and residency requirements, 61% of EC respondents recommended that personal data should be hosted at the investigator site. Regional differences existed with 77% of European EC respondents recommending the on-site hosting of personal data versus 60% of Russian, 44% of North American, and 25% of Malaysian EC respondents.

While EC respondents expressed a preference for on-site hosting, it must be noted that not all sites may have the necessary infrastructure or manpower to support on-site data hosting. Without any doubt, participant data and participant personal data protection falls under the responsibility of the site, but there are also other ways that this can be achieved. For example, by validated, secure and controlled data encryption, data transfer and data access, while maintaining and offering a more harmonized approach and access to eConsent for sites and their participants.

6. Limited impact on monitoring or archival requirements expected by ECs

The majority of the EC respondents indicated that there is no difference in monitoring requirements compared to paper (90%), nor that eConsent archival requirements exceeded GCP requirements (80%). Half of the EC respondents (51%) indicated that they had an ICF guidance document available, of which 60% indicated that no updates were needed to cover the use of eConsent.

Sponsor and vendor eConsent survey: Key highlights

1. Sponsor/vendor eConsent survey respondents characteristics

In total, 42 respondents completed the sponsor/vendor eConsent survey with 67% sponsor and 33% vendor respondents.

As expected, vendors reported a higher eConsent experience compared to sponsors: 36% of sponsor respondents had no eConsent experience versus 7% of vendor respondents.

2. Compliance and patient-centricity: The most important drivers for sponsors and vendors

90% of sponsor/vendor respondents scored improved compliance and quality of the consent process as the most important factors driving the use of eConsent. That number increases to 96% if we consider only the sponsor representative responses. Patient-centricity was another important factor, scoring 86% across the combined sponsor/vendor group and it was even the number one factor considered by vendors. Other important factors, ranging from 50% to 60%, were enabling decentralized trials, integration with other clinical systems, reduction of dropout, and improvement of recruitment rates.

3. Site adoption and regulatory approval concerns: The most significant barriers for sponsors and vendors

Poor site adoption was considered the most significant barrier by sponsor respondents (61%), whereas vendor respondents noted regulatory approval concerns (43%) as the most important barrier. High cost was ranked as the third significant barrier by both sponsors (36%) and vendors (29%). Lack of organizational delivery structure and process (32%), challenges with an eConsent platform (29%), and delay in timelines (29%) were considered as significant barriers by sponsor respondents but limited or not even seen as a barrier by vendor respondents, as illustrated in Figure 4.

4. Video: A valuable yet underutilized eConsent digital feature by sponsors and vendors

The video digital feature perceived the highest score (79%) by sponsor/vendor respondents on the value matrix of digital features, followed by dictionary/glossary (48%), content flags (45%), knowledge checks (33%), and links to other websites (33%). Comment boxes (17%) and chat boxes (10%) were less frequently rated as extremely useful digital features.

The frequency of deployment of digital features did not necessarily mirror the usefulness perception. As shown in Figure 5, 79% of sponsor/vendor respondents considered the video as extremely useful but only 57% had used it. Similarly, some digital features perceived as less useful (e.g. chat box, comment box) were deployed by ~30% of sponsor/vendor respondents.

5. Live video call with investigator: The most common used remote consent authentication methods

Live video call with investigator (43%), two-factor authentication (33%), and a Qualified Trust Service Provider ID verification (21%) were reported by sponsor/vendor respondents as the most commonly used Participant Authentication Methods for remote eConsent. Exchange of random code in conjunction with a phone call (10%) and CAPTCHA (5%) were less commonly used. A high number of sponsor/vendor respondents (45%) also selected “Other,” which included methods such as signatures collected at the site, or post office verification, as well as some respondents indicating that they had no experience with the topic.

Submission requirements aligned among ECs, sponsors, and vendors

Both EC and sponsor/vendor respondents evaluated the EC submission requirements. System privacy and security documentation (69%), attestation that eConsent content is identical to paper content (55%), system-printed PDF of the document (55%), and screenshots of digitized content (51%) were highest scored by EC respondents, followed by story boards of multimedia content (33%) and access to the eConsent platform (29%). Comparable categorizations were given by sponsor/vendor respondents although they gave a higher score for screenshots of digitized consent (67%) and storyboards of multimedia content (48%).

Conclusion: One step closer towards transparency and clarity

Creating transparency in perspectives by directly inquiring with the involved stakeholders, instead of making assumptions on their behalf, is overall considered the best approach but in practice not so often implemented. The survey results presented in this article directly present the views of ECs, sponsors, and vendors.

What we learned is that, not surprisingly, the most important items for ECs are:

ensure the participant-investigator interaction is not impacted

ensure a paper option is available to enable broad inclusiveness

ensure participant data and identity are securely stored and protected

There were clearly differences between European and North American EC respondents, but some were much less profound or not as expected with some examples shown in Figure 6. More examples and details can be accessed through the supplemental information section.

Similarly, sponsor/vendor survey results showed alignment but also differences, especially when it comes to drivers and barriers. For example, ~30% of sponsor respondents considered challenges with an eConsent platform, delays in timelines, and lack in organization delivery structure and process to be a significant barrier, while this was limited or not seen as a barrier by vendor respondents.

To note, survey results represent only a small fraction of the global community. In addition, to date, there are still many different interpretations and misunderstandings of what eConsent is about, which might have impacted the responses given by the different stakeholders.

The survey results described in this article represent another outcome of the EFGCP eConsent initiative, one of the largest and most collaborative industry efforts in eConsent. Other tools developed are:

: covering over 60 eConsent platform and operational aspects terminologies, definitions and examples

: covering recommendations for nine different study documents on various eConsent platform and operational aspects

: providing a 5-process flow to define and design the right eConsent for a particular study and its stakeholders, and to analyze and generate effective and comparable study data on eConsent

Upfront interactions on eConsent with key stakeholders, such as Ethics Committees, remain also very valuable as previously recommended by the involved stakeholders.

Key to remember is that there is no one-size-fits-all eConsent model. Each study, each indication, each participant, and each site might have its own requirements. The suite of eConsent tools listed above is publicly available on the 

 and we hope you will join our journey to bring eConsent to the place it deserves.

The detailed results of the ECs eConsent survey and sponsors/vendors eConsent survey are available at the EFGCP eConsent 

This significant work would not have been achievable without the dedication and support of the EFGCP eConsent database workstream team. We would also like to express our gratitude to all the organizations that participated in the online surveys.

 (EFGCP, TCS) spearheads the EFGCP eConsent Initiative consisting of 6 workstreams. 

 (Biogen) is a co-leader of the EFGCP eConsent Database workstream responsible for this article. 

(Freelance consultant) are members of the Database Workstream.

https://www.appliedclinicaltrialsonline.com/view/econsent-why-language-matters

Glossary of eConsent Terms. EFGCP eConsent website, 5 July 2024. 

https://efgcp.eu/public/EFGCP%20Glossary%20of%20eConsent%20Terms.pdf

ICH Harmonized Guideline, Good Clinical Practice (GCP) E6(R3), Draft version 19 May 2023. 

https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf

HMA, EC & EMA, Recommendation Paper on Decentralized Elements in Clinical Trials, Version 1, 13 December 2022. 

https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en

EU Regulation on Electronic Identification and Trust Services for Electronic Transactions in the Internal Market (eIDAS), July 2014. 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2014.257.01.0073.01.ENG

Digital literacy in the EU: An overview. 6 December 2023. 

https://data.europa.eu/en/publications/datastories/digital-literacy-eu-overview

Navigating eConsent Submissions: Who, What, Where and Why? 

https://www.appliedclinicaltrialsonline.com/view/navigating-econsent-submissions-who-what-where-and-why-

eConsent Study Documents Recommendations. EFGCP eConsent website, 5 July 2024. 

https://efgcp.eu/public/eConsent%20Study%20Documents%20Recommendations.pdf

Effective eConsent Strategies for Every Study: Utilizing the eConsent Fit-for-Purpose Study Framework. 

https://www.appliedclinicaltrialsonline.com/view/effective-econsent-strategies-fit-for-purpose-study-framework

eConsent Fit-for-Purpose Study Framework. EFGCP eConsent website, 12 August 2024. 

https://efgcp.eu/public/eConsent%20Fit%20For%20Purpose%20Framework.pdf

Awareness and Collaboration across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption. 

Therapeutic Innovative Regulatory Science

https://journals.sagepub.com/doi/full/10.1177/2168479019861924

Using surveys to collect various viewpoints on eConsent from ethics, sponsors, and vendors.

Understanding Acceptability of eConsent from a Global, Ethical, and Industry Perspective

Emerging investigators play a vital role in bringing new patient populations to clinical trials, but reservations around their ability to deliver persist. Recruitment and retention continue to pose a hurdle to clinical research resulting in increasing recruitment of practicing physicians outside of academic centers, and for good reason.

Investigators with a rural practice, such as mine in Stephenville, TX, add more geographic variability to the predominantly urban and suburban landscape of clinical trials. As community physicians, we are often also able to reach more ethnically and racially diverse participants, due to close personal ties with patients in these areas.

Such recruitment benefits impart a compelling endorsement of emerging investigators. However, several additional advantages of engaging these investigators in clinical trials are less frequently discussed.

Strong familiarity with patients and communities

When physician investigators such as myself are embedded within a community practice, we have intimate knowledge about the patient populations served. As a result, we provide valuable (and otherwise unobtainable) input for many aspects of study design. This begins with recruitment. For example, we can predict which trial designs will be palatable for our patients. We also have insight into factors that will aid in participant retention, such as a clearer understanding of which trials and protocol iterations will be more attractive to our patient population. Many times, I have provided feedback to sponsors about protocol design that could be off-putting to the targeted patient population and the sponsors listen.I see many subjects in the research clinic and my personal clinic, which improves communication, compliance with e-diaries due to reminders of the importance of data collection, and enthusiasm for continuing with clinical research. Research is only a small facet of my relationship with most of our subjects and thus, they trust the research center and fewer barriers impeded retention and compliance.

Patient care backed by personal connection

Our concern for the health of our patients leads us to genuinely and enthusiastically encourage them to participate in trials that we think will help them. I have practiced in my community for ten years, and I plan on practicing for many more. Beyond my professional obligation, I have relationships with people within the community who go on to become trial participants—I see them at the grocery store, at football games, and in church.

My greatest source of pride as an emerging investigator is being able to provide newer treatment options and medical care to those who would not otherwise have access. Additionally, through the trial screening process, we have the potential to unearth other health conditions that were previously unnoticed. A few months ago, at a screening visit we noted some EKG changes in a patient with cardiovascular disease, and referred them to a cardiologist, where they received catheterization and stents before having a cardiovascular event. We have also screened for cervical cancer and sexually transmitted diseases as part of a birth control study and identified disease in women who were not previously aware of their health status—and did not have access to cervical cancer screening otherwise.

Providing these services to our patients through an integrated approach to trial delivery is extremely motivating for us as investigators. Because clinical research is established within our healthcare practices, trial participation is accessible as part of our overall offerings. This provides added value to our patients, while also providing momentum supporting clinical research advancement as a whole.

Emerging investigators often ask a lot of questions at the outset of a trial, reaching out to colleagues, trial support staff and even leadership from our sponsor or vendor partners. We must seek out best practices as we gather knowledge about the trial landscape. This leads to valuable interaction and collaboration. Fresh eyes on a protocol can only augment the sponsors’ offerings through the application of clinic curiosity.

There is no doubt that new investigators need support as they enter their first trials. Sponsors might hesitate to include new clinic-based investigators due to fear of compromised data, laxity concerning GCP procedures, difficulty managing investigational product, and so on. In my very real-world experience, with the proper partnerships, infrastructure, processes and plans, getting started really can be relatively frictionless. The clinical investigator’s initial curiosity and collaborative spirit surmount these barriers and allow the embedded clinical research center to truly thrive, despite industry’s initial hesitations concerning their lack of experience.

In the beginning, my greatest challenge in Stephenville was to train staff. This did take some time, but it was made possible through collaboration with our clinical research partner, Javara, an integrated research organization (IRO). They are contracted by my medical group, Privia Health. With Javara’s support, combined with online training resources, we rapidly gained the knowledge and skills necessary to launch clinical trials from our practice.

This partnership has continued and is central to how we conduct all our clinical trials. In addition to serving as an investigator, I am also the medical director of clinical research for Privia Health in North Texas and meet with Javara leadership once or twice a month. This is a chance to offer feedback on our successes as well as any challenges we are experiencing. Close collaboration of this nature really allows emerging investigators to stay curious and to bring a fresh perspective to the conversation. With the right support, we can contribute to clinical research as efficiently as those more experienced in the field.

Without the help of a knowledgeable IRO or CRO partner, I would not have been able to manage clinical research independently. They oversee staff, provide necessary equipment and guide our team through regulatory documents and processes. This support also helps allay any compliance risks that can emerge, given the level of scrutiny faced by clinical trials.

A fresh approach and enthusiastic mindset

As we emerging investigators embark upon our journey into clinical research, we are not tied to certain processes or procedures. There is no obligation to maintain the status quo, and we are less apt to accept the “it’s the way it’s always been done” mentality. I believe our open-mindedness provides all stakeholders a unique opportunity to explore newer methods and systems during mentorship and training as well as throughout a clinical trial. The landscape of new digital tools and platforms, including artificial intelligence applications, is continually changing. Those of us newer to research often tend to be more open to embracing such tools because our instruction does not require any unlearning and thus saves time, energy, and potentially resources.

New clinic-based investigators are enthusiastic. We are accustomed to long hours and the intricacies of clinical practice and clinical research offers the emerging investigator a new and exhilarant flavor to our daily work. I have been thrilled with my journey into the world of clinical research, as it gives me an opportunity to learn about new medications and treatment regimens as they are being developed. This has helped to keep me on the cutting edge of advancements in medical science, and I have been able to keep my patients informed about what is on the horizon.

Clinical practitioners can sometimes fall into the habit of treating the same old maladies with the same old therapies—that may or may not exhibit the efficacy desired. Every day it seems, there is a new opportunity in my inbox, and I relish reading about the novel mechanisms of action and therapeutic targets I get to participate in bringing to those that need them most. This translates into an enthusiasm for the work that drives my desire to engage subjects and keep them engaged. Ultimately, I believe the spirit of clinical investigators positively affects the clinical trial ecosystem. Our patients sense our enthusiasm for their care, and I have seen this spirit invigorate other research staff at investigator meetings as well.

New investigators practicing in community-based settings bring enthusiasm and a fresh approach to clinical research, while also boosting collaboration and merging personal connection and patient-centric insights.

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