Consent In Clinical Trials Research Articles

Researchers experience and views on participants’ comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study

BackgroundInformed consent is the cornerstone of research ethics. One of its goals is that participants enter research with an understanding of what their participation entails. This paper is a study on how researchers understand the informed consent process. Previous studies have looked at this topic from a research participant perspective. However, few studies focus on the perspectives of the researchers. Therefore, this is an important paper that highlights an important issue (informed consent) from the perspective of those who administer it during research.MethodsIn-depth interviews were conducted with 18 researchers from 3 different research centers in Malawi working in clinical trials. The data was analyzed using open code utilizing the thematic approach to qualitative data.ResultsThis study identified that researchers have good awareness of the role of informed consent, how important it is for participants to understand the given information and ways to adjust their practice accordingly when obtaining it in order to enhance participant understanding. According to the research staff, most participants do not really understand all the concepts of the study at the initial visit, they gain more understanding during subsequent visits. It was emphasized that the best method of facilitating informed consent is reading the informed consent to the participant, thus a face-to-face conversation. Long and complex informed consent was identified as one of the barriers to participant understanding of the informed consent. Shortening the informed consent form and having additional conversation with the participants was suggested as one way of improving participant comprehension.ConclusionMost of the participants understand much of the information during subsequent visits as you keep reminding them since informed consent is an ongoing process. Existing relationship or trust between a participant and a researcher, may influence participants’ decision and misguide their understanding on the purpose of the study. Adequate time should be allocated to informed consent discussions. Shortening the informed consent forms and having additional conversations with potential participants may help improve their understanding.

Abstract IA013: Increasing Diversity in Pediatric Cancer Clinical Trials: Challenges and Opportunities

Abstract Although childhood cancer is the leading cause of death by disease past infancy in the US, with 17,000 children younger than 21 years being diagnosed annually, survival has improved dramatically, and is now greater than 80% overall. Because of unequal access to services and adverse Social Determinants of Health (SDOH) affecting underserved populations, disparities in survival exist among minoritized youth with cancer. For example, Hispanic children have higher incidence of certain cancers and poorer survival rates than non-Hispanic White children. Minorities are severely under-represented in research. This means that cancer outcomes data are largely based on data from non-Hispanic White participants, and there is incomplete information to adequately assess treatment benefits for minorities. We showed that 53% of Latino parents declined research participation, compared to 20% of non-Hispanic White parents, in our institution. There are several barriers to informed consent for clinical trials. First, there are no mandates to ensure comprehension, and informed consent forms are complex, long, and difficult to understand. This leaves parents of children with cancer with an incomplete understanding of risks, procedures, randomization, alternative treatments, and the voluntary nature of clinical trial participation. Furthermore, pediatric cancer often requires urgent treatment, leaving little time for decision-making. We developed COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn), a peer-navigation intervention to improve research literacy and diversity in pediatric cancer clinical trials. In this intervention, trained peer-navigators, who have the lived experience of having a child diagnosed with cancer, provide in-hospital support. The goals of COMPRENDO are to improve parents’ informed consent experience and comprehension of informed consent for cancer treatment, to explain to parents terms to be discussed by the oncologist during the treatment conference, to introduce to parents concepts of clinical trials and research, and to facilitate and empower shared decision-making. In a pilot study at Rady Children’s Hospital-San Diego, this intervention showed a significant increase in comprehension of therapeutic trials, particularly in Hispanic and Spanish-speaking parents. The demographics of children with cancer enrolled in clinical trials should be comparable to the US population, and approaches to improve enrollment must also be tailored to specific settings. Structural barriers for participation of minorities should be considered during study and informed consent design and planning. Strategies to increase clinical trial enrollment of minority individuals include: Provider-level training on patient-provider communication, development of linguistically appropriate tools, and promotion of culturally aware staff. Key strategies at the patient-level include building trust; education and awareness of clinical trials; implementation of culture, language, and health literacy-concordant interventions; and initiatives to address adverse SDOH. Citation Format: Paula Aristizabal. Increasing Diversity in Pediatric Cancer Clinical Trials: Challenges and Opportunities [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pediatric Cancer Research; 2024 Sep 5-8; Toronto, Ontario, Canada. Philadelphia (PA): AACR; Cancer Res 2024;84(17 Suppl):Abstract nr IA013.

CLARA-MeD Tool - A System to Help Patients Understand Clinical Trial Announcements and Consent Forms in Spanish.

We present an NLP web-based tool to help users understand consent forms (CFs) and clinical trial announcements (CTAs) in Spanish. For complex word identification, we collected: 1) a lexicon of technical terms and simplified synonyms (14 465 entries); and 2) a glossary (70 547 terms) with explanations from sources such as UMLS, the NCI dictionary, Orphadata or the FDA. For development, we extracted entities from 60 CTAs, 60 CFs and 60 patient information documents (PIDs). To prepare definitions for new terms, we used ChatGPT and experts validated them (28.99% needed to be fixed). We tested the system on 15 new CTAs, 15 CFs, and 15 PIDs, and we achieved an average F1 score of 82.91% (strict match) and of 94.65% (relaxed). The tool is available at: http://claramed.csic.es/demo.

Towards an understanding of the ethics of electronic consent in clinical trials

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

Quality of Informed Consent in Phase III Clinical Trials in Portugal: The Participants' Perspective.

Some studies show that participants do not always fully understand the informed consent form (ICF), which is one of the reasons for dropouts. This study aimed to adapt the Quality of Informed Consent (QuIC) questionnaire into a valid instrument to be applied to the Portuguese population and to measure its reliability and validity in the Portuguese population, by applying it to a sample of participants in controlled trials. The QuIC questionnaire was developed to assess the quality of informed consent in clinical trials and consists of two parts, addressing both the objective (part A) and the subjective (part B) understanding. After being translated and validated into Portuguese, it was implemented in 100 cardiac participants of phase III clinical trials in a University Hospital Center. The QuIC-PT questionnaire showed excellent stability over time and good validity. All patients evaluated their participation and their health positively and recognized the main purpose of the clinical trial. Almost all participants understood their role in helping future patients and the purpose of the trial and realized that, by signing the ICF, they were participating in a clinical trial. However, none of them knew that their experimental treatment was not proven to be the best alternative for their condition. The QuIC-PT questionnaire seems to be a valid and useful instrument to evaluate the participants' understanding of the ICF. In this study, we found that some concepts, like 'study protocol' or 'randomization', were not well understood by participants when signing the ICF, especially by participants with lower education levels. They also believed that the experimental intervention would solve their health condition. Greater awareness about the importance of the informed consent process and ICF is necessary so that participants can fully understand the protocol, especially the risks involved, and their rights as participants.

Coerced consent in clinical research: study protocol for a randomized controlled trial

BackgroundDespite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies.MethodsWe describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women’s College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial.DiscussionThis study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients.Trial registrationThe trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.

Obtaining informed consent in veterinary clinical trials mini review.

In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.

Are the clinical trials in lung cancer an advantage for patients in developing countries?

e20523 Background: Clinical trials are critical to developing new drugs. This study examined the characteristics of patients diagnosed with metastatic non-small cell lung cancer (mNSCLC) and who wanted to participate in clinical trials. This study aims to compare the outcomes of patients who enrolled in clinical trials or not. Methods: The data of the patients who applied to Ankara Yildirim Beyazit University Medical Oncology Department to participate in the first-line treatment-related clinical trials in mNSCLC were retrospectively reviewed. Survival outcomes of patients included in clinical trials (CT) and patients who signed informed consent for clinical trials but could not enroll (standard treatment-ST) were compared. Results: Data from 155 patients who applied to participate in clinical trials were analyzed. Patients who died during the screening process and who lacked systemic treatment information were excluded (n = 14). While 55.3% (n = 78) of the patients participated in the clinical trials, 44.7% (n = 63) could not. Not meeting the inclusion criteria (pathological and clinical) was the most common reason for screen-fail. At a median follow-up of 29 months, median overall survival was 17.1 months (95%CI, 15.1 to 19.1) in the CT group and 9.6 months (95%CI, 7.1 to 12.1) in the ST group (p = 0.015). Median progression-free survival was 11.6 (95% CI, 5.9 - 17.4) and 5.4 (95% CI, 3.7 - 7.2) months, respectively (p = 0.014). Conclusions: Being able to take part in clinical trials is not unfavorable, and it may even improve survival for patients with metastatic non-small cell lung cancer (mNSCLC), particularly in areas of the world where access to novel and effective treatments is limited.

A reactogenic "placebo" and the ethics of informed consent in Gardasil HPV vaccine clinical trials: A case study from Denmark.

Medical ethics guidelines require of clinical trial investigators and sponsors to inform prospective trial participants of all known and potential risks associated with investigational medical products, and to obtain their free informed consent. These guidelines also require that clinical research be so designed as to minimize harms and maximize benefits. To examine Merck's scientific rationale for using a reactogenic aluminum-containing "placebo" in Gardasil HPV vaccine pre-licensure clinical trials. We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines. It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study's primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck's proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant "placebo" group. In our view, the administration of a reactive placebo in Gardasil clinical trials was without any possible benefit, needlessly exposed study subjects to risks, and was therefore a violation of medical ethics. The routine use of aluminum adjuvants as "placebos" in vaccine clinical trials is inappropriate as it hinders the discovery of vaccine-related safety signals.

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Contraception Requirements in Clinical Research Consent Forms: Assessing and Supporting Gender Inclusive Practices.

Gender-diverse individuals are underserved in clinical research settings. Reliance on gendered language throughout the consent process for clinical research contributes to the marginalization of these populations. The research objective was to assess use of gender-inclusive language used to describe the contraception requirement in consent forms. We categorized and analyzed contraception language in 289 clinical trial consent forms using a deductive and summative content analysis approach. We found that 79% (n = 227) of consent forms contained gender-inclusive language, 80% (n = 231) used terms that fell under the biological sex language, and 91% (n = 264) used gendered language. No consent forms used exclusively gender-inclusive language and the majority 63% (n = 182) featuring a combination of all three language types. There were many consent forms which would have been entirely gender-inclusive language if section headings with references to biological-sex-specific contraceptives were excluded, suggesting that gender-inclusive language may be attainable with minor revisions.

Public perception of participation in low-risk clinical trials in critical care using waived consent: a Canadian national survey.

The acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials. We performed a prospective cross-sectional survey of the Canadian public aged 18yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee. The survey focused on attitudes and beliefs on waived consent for participation in low-risk clinical trials in ICU settings. The survey contained 35 items focused on sociodemographics, general health status, participation in medical research, and levels of support and comfort with research and with waived consent. The survey used a case study of a low-risk clinical trial intervention in ICU patients. Analysis was descriptive. We included 2,000 participants, 38% of whom reported experience with ICU and 16% with medical research. Participation in medical research was more common among those with postsecondary education, those with chronic disease, and those who were employed in health care. Most (80%) would support a model of waived consent for low-risk clinical trials, citing medical benefits (36%) and low perceived risk (34%). Most (77%) were comfortable with personally participating in a low-risk clinical trial. Most (80%) believed waived consent approaches were acceptable. Half (52%) believed the waived consent process should provide information about the research and include the option of opting out. When asked whether participants should always give full informed consent, regardless of the practicality or level of risk, 74% and 72% agreed, respectively. There is public support for models of waived consent for participation in low-risk pragmatic clinical trials in ICU settings in Canada; however, this is not universal. This information can inform and guide education, ethics, policy, and legal discussion on consent models.

Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda

ObjectivesTo examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.DesignMixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with indepth interviews.Setting and participantsFrom January 2021...

Practical approaches for supporting informed consent in neonatal clinical trials.

The survival and health of preterm and critically ill infants have markedly improved over the past 50 years, supported by well-conducted neonatal research. However, newborn research is difficult to undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials. CONCLUSION: The authors provide practical guidance on the design and implementation of an effective consent checklist tailored for use in neonatal clinical research.

Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.

Obtaining written informed consent from participants before enrolment in a study is essential. A previous study showed that only 50% of the participants in clinical trials understood the components of informed consent, and the methods of participants' understanding of informed consent were controversial. This updated meta-analysis aimed to estimate the proportion of participants in clinical trials who understand the different informed consent components. PubMed, EMBASE, the Cochrane Library, and Scopus were searched till April 2023. Therapeutic misconception, ability to name one risk, knowing that treatments were being compared, and understanding the nature of the study, the purpose of the study, the risks and side-effects, the direct benefits, placebo, randomization, voluntariness, freedom to withdraw, the availability of alternative treatment if withdrawn from the trial, confidentiality, compensation, or comprehension were evaluated. This meta-analysis included 117 studies (155 datasets; 22,118 participants). The understanding of the risks and side-effects was investigated in the largest number of studies (n = 100), whereas comparehension was investigated in the smallest number (n = 11). The highest proportions were 97.5%(95% confidence interval (CI): 97.1-97.9) for confidentiality, 95.9% (95% confidence interval (CI): 95.4-96.4) for compensation, 91.4% (95% CI: 90.7-92.1) for the nature of study, 68.1% (95% CI: 51.6-84.6) for knowing that treatments were being compared, and 67.3% (95% CI: 56.6-78) for voluntary nature of participants. The smallest proportions were the concept of placebo (4.8%, 95%CI: 4.4-5.2) and randomization(39.4%, 95%CI: 38.3-40.4). Our findings suggested that most participants understood the fundamental components of informed consent (study confidentiality, nature, compensation, voluntariness, and freedom to withdraw). The understanding of other components, such as placebo and randomization was less satisfactory.

Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?

Changes in the clinical trials landscape have been driven by advancements in digital technology. The use of electronic informed consent to inform research participants and to obtain their consent electronically has the potential to improve participant-researcher interactions over time, facilitate clinical trial participation, and increase efficiency in clinical trial conduct. A personalized electronic informed consent platform that enables long-term interactions with the research team could function as a tool to empower participant engagement in clinical trials. However, significant challenges persist impeding successful and widespread implementation. This Perspective provides insights into the opportunities and challenges for the implementation of electronic informed consent in clinical trials. It sets out key recommendations to promote the implementation of this innovative approach to the informed consent process, including the creation of uniform electronic informed consent platforms at regional and national level.

Longitudinal assessment of an Ebola vaccine trial understanding among healthcare providers in the Democratic Republic of the Congo

BackgroundThe long-term retention of information disclosed during the informed consent in clinical trials lasting over a year cannot be guaranteed for all volunteers. This study aimed to assess the level of participants’ retention and understanding of the trial information after two years of participation in a vaccine trial. MethodsIn total, 699 health care providers (HCPs) and frontline workers were enrolled in the EBL2007 vaccine trial conducted between February 2019 and September 2022 in the Health District of Boende, Democratic Republic of the Congo (DRC). Individual scores obtained from a questionnaire (test of understanding, TOU), specifically designed to assess the understanding of the consent at baseline, were collected before the clinical trial started and at one-year and two-year intervals. ResultsTOU scores were high in the beginning of the trial (median TOU = 10/10), but significantly decreased in both the first and second years following (median TOU = 8/10 in year 1 and median TOU = 9/10 in year 2, p-value < 0.0001). The decrease in scores was significantly higher among individuals with occupations requiring shorter education such as midwives (median TOU = 7/10 in year 1 and 8/10 in year 2, pvalue = 0.025). Furthermore, older participants exhibited poorer retention of information compared to younger individuals (median TOU = 8/10 vs 9/10, p-value = 0.007). ConclusionWe observed a significant decline in the informational knowledge of informed consent, specifically in terms of basic knowledge on the study vaccine and trial procedures. As participant safety and understanding is a paramount ethical concern for researchers, it is crucial for participants to fully comprehend the study's objectives and potential risks. Therefore, our findings suggest the need for clinical researchers to re-explain participants to optimize the protection of their rights and wellbeing during the research.

An absence of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants

ObjectivesA lack of diversity amongst participants in cancer clinical trials has raised scrutiny over the past decade. Patients with limited English proficiency (LEP) are further excluded. One modifiable reason for low LEP participation is a lack of non-English consent forms. MethodsWe queried the clinical trials registry database at an academic hospital serving a predominantly Spanish-speaking patient population. Clinical trials related to gynecology oncology were evaluated for the availability of fully translated Spanish consent forms, the racial and ethnic identification of enrolled patients, and the number of signed Spanish consents. Enrolment data was compared before and after 2019, when institutional financial support for document translation was withdrawn. ResultsSixteen gynecologic oncology clinical trials were opened between 2014 and 2022, with 10 trials enrolling 128 patients. Eight trials opened prior to 2019, all with fully translated consent forms. Seven of these trials enrolled 99 participants, 70% of whom identified as Hispanic and 60% who signed a Spanish consent. Eight trials opened after 2019 and one had a fully translated consent form. Three of the trials enrolled 29 participants, with 10% of subjects identifying as Hispanic and none signing a Spanish consent form. ConclusionsThere was a decrease in fully translated clinical trial consent forms for gynecologic oncology studies following the loss of subsidized translation services in our single institution with a predominantly LEP population. This correlated with a decrease in enrollment of Hispanic subjects. To increase enrollment of diverse participants, including those with LEP, simple actions such as fully translating consent forms would help maintain equity in research conduct and improve clinical outcomes through trial involvement.

Telemedicine electronic consenting preference among clinical trial participants.

516 Background: Telemedicine (TM) disparities in the US during the pandemic are well-reported; however, its use by diverse participants providing electronic informed consent (eIC) for clinical trials in oncology remains unexplored. Our previous research found eIC comparable to in-person paper-based visits across participants: stress, technology burden, comprehension, and agency for complex clinical genetic and Phase I-II clinical trial discussions. Based on this work, we hypothesized that our implementation of eIC via TM would be well received, and we evaluated participant characteristics associated with their consent method preferences. Methods: Research participants with in-person clinic and TM eIC visits from Aug 2021- Jan 2023 received anonymous, uncompensated surveys electronically. We assessed age, sex, primary language, ethnicity, race, and 3 groups of survey questions generated from factor analysis: 1) TM usability, 2) TM satisfaction and 3) eIC process comfort (comfort using TM for eIC) (Table). A multivariable multinomial regression model evaluated associations between factors and eIC preference, a survey item assessing overall preference for eIC via TM or in-person or no preference. Results: Among 1,154 respondents (28% response rate), 52% preferred TM for eIC, 29% had no preference, and 19% preferred in-person. Respondent median age was 65; 51% were male; 97% English speaking; 6% were Hispanic; 84% White, 7.7% Asian-Far East/Indian Subcontinent, 5.3% Black, 2.6% other. Non-native English speakers (odds ratio (OR) 0.31; 95% confidence interval (CI) (0.1, 0.93), p=0.037) and Black participants (OR 0.37; 95% CI (0.16, 0.83), p=0.016) had decreased odds of preferring TM to in-person for eIC. Similarly, increased age (OR 0.98; 95% CI (0.96, 0.99), p=0.008) was associated with a decrease in no preference compared to in-person preference for eIC. Conclusions: Most participants preferred TM for eIC or had no preference. However, adjusting for eIC process comfort, TM satisfaction, and other demographics, participants who were Black, older, or non-native English speakers were more likely to prefer in-person for eIC. Our future research will target these areas to help support equitable consenting standards and care.[Table: see text]

Improving clinical trial consent form readability through artificial intelligence.

109 Background: High literacy levels are needed to understand oncology clinical trial (CT) informed consent forms (ICF), which represents a barrier to enrollment of older adults and diverse populations. ChatGPT-4 is an artificial intelligence chatbot that responds to user prompts and can summarize large amounts of text. We tested whether ChatGPT-4 could simplify CT information from ICFs. Methods: On May 22, 2023, we searched clinicaltrials.gov for interventional, therapeutic, NIH-funded, CTs involving adults with the 14 most prevalent cancer types. Only CTs with available study protocols that were currently recruiting, “enrolling by invitation”, and “active not recruiting” were included. Trials that were diagnostic, preventative, or supportive were excluded. Publicly available ICFs from the resulting CTs were downloaded and analyzed. Using the ChatGPT-4 plugin askyourpdf.com, we asked ChatGPT-4 to review each ICF and answer 8 questions recommended by the NCCN for patients considering a CT in a 6th grade literacy level. Our prompt included the following 8 questions: “1) What are the treatments used in the clinical trial? 2) Has the treatment been used for other types of cancer? 3) What are the risks and benefits of this treatment? 4) What side effects should I expect and how will they be managed? 5) How long will I be in the clinical trial? 6) Will I be able to get other treatment if this doesn’t work? 7) How will you know if the treatment is working? 8) Will the clinical trial cost me anything?” Reading level (readability) was assessed for both the ICFs and ChatGPT-4’s question responses using the validated Flesch-Kincaid (FK), Gunning Fog (GF), and SMOG indices using the online Readable App. Data was summarized with descriptive statistics and t-test was used to compare text reading levels between ICFs and ChatGPT-4’s answers. Results: Our search yielded 83 therapeutic oncology CTs, of which 70 had publicly available ICFs. ChatGPT-4 successfully analyzed 66 of the 70 ICFs (94.3%). The mean text reading levels of its answers were 6.2 (95% CI: 5.9-6.5), 8.6 (95% CI: 8.2-8.9), and 9.2 (95% CI: 8.9-9.4) based on FK, GF, and SMOG indices, respectively. Of 70 ICFs, 54 (77.1%) contained text that could be evaluated for readability analysis and were included in the analysis. The mean text reading levels was 7.9 (95% CI: 7.7-8.1), 9.3 (95% CI: 9.1-9.6), and 10.5 (95% CI: 10.2-10.8) based on FK, GF, and SMOG indices, respectively. ChatGPT-4’s text responses had a significantly lower reading level compared to ICFs text for all three readability indices (FK: p&lt;0.01, GF: p=0.02, SMOG: p&lt;0.01). Conclusions: ChatGPT-4 presented key information from oncology CT ICFs at a 6th to 9th grade reading level, which was significantly lower than the original ICFs. While further studies are needed to assess ChatGPT-4’s accuracy, this study shows its potential as tool for improving patients’ understanding of oncology CTs.