Industry-sponsored Clinical Trials Research Articles

Postapproval Innovation For Oncology Drugs And The Inflation Reduction Act.

The Inflation Reduction Act's Drug Price Negotiation Program (DPNP) will affect incentives for biopharmaceutical investment by reducing prices and expected profits. Discussion has focused on the program's potential impact on the number of new drugs, but postapproval activity, which is common in oncology, will also be affected. If the history we describe is representative, postapproval exposure to DPNP eligibility dates would be high for oncology drugs. For 155 oncology drugs approved during the period 2000-21 (112 small molecules and 43 biologics), 57percent of labeled indications approved by the Food and Drug Administration and 68percent of industry-sponsored clinical trials occurred postapproval, often near or after DPNP selection dates. Compared with biologics, exposure to DPNP eligibility dates is more than twice as high for small molecules; although expected durations from drug approval to trial end are shorter, DPNP eligibility dates occur much sooner. Areas of potential postapproval impact include additional tumor types; rare diseases, particularly for drugs with multiple orphan indications; and pediatric indications, of which two-thirds occurred postapproval.

Accessibility of clinical study reports supporting medicine approvals: a cross-sectional evaluation

ObjectivesClinical study reports (CSRs) are highly detailed documents that play a pivotal role in medicine approval processes. Though not historically publicly available, in recent years, major entities including the European Medicines Agency (EMA), Health Canada, and the US Food and Drug Administration (FDA) have highlighted the importance of CSR accessibility. The primary objective herein was to determine the proportion of CSRs that support medicine approvals available for public download as well as the proportion eligible for independent researcher request via the study sponsor. Study Design and SettingThis cross-sectional study examined the accessibility of CSRs from industry-sponsored clinical trials whose results were reported in the FDA-authorized drug labels of the top 30 highest-revenue medicines of 2021. We determined (1) whether the CSRs were available for download from a public repository, and (2) whether the CSRs were eligible for request by independent researchers based on trial sponsors’ data sharing policies. ResultsThere were 316 industry-sponsored clinical trials with results presented in the FDA-authorized drug labels of the 30 sampled medicines. Of these trials, CSRs were available for public download from 70 (22%), with 37 available at EMA and 40 at Health Canada repositories. While pharmaceutical company platforms offered no direct downloads of CSRs, sponsors confirmed that CSRs from 183 (58%) of the 316 clinical trials were eligible for independent researcher request via the submission of a research proposal. Overall, 218 (69%) of the sampled clinical trials had CSRs available for public download and/or were eligible for request from the trial sponsor. ConclusionCSRs were available from 69% of the clinical trials supporting regulatory approval of the 30 medicines sampled. However, only 22% of the CSRs were directly downloadable from regulatory agencies, the remaining required a formal application process to request access to the CSR from the study sponsor.

Recent landscape and trends for industry-sponsored pediatric clinical trials in China from 2013 to 2022.

Pediatric medication is a challenging issue globally. Promoting trials of medications for children and implementing measures to encourage innovation for addressing unmet medical and health needs are important. To explore the recent landscape of pediatric clinical trials of new investigational drugs conducted by pharmaceutical enterprises in China from 2013 to 2022 to provide insight into pediatric drug development in the pharmaceutical industry and regulatory policy formulation. We performed a cross-sectional observational investigation of pediatric clinical trials registered from January 1, 2013, to December 31, 2022, on the Registration and Information Disclosure Platform for Drug Clinical Trials, the official registration platform established in 2013 for trials of new investigational drugs initiated by biopharmaceutical enterprises. Trials that included pediatric participants (under 18 years old) were retrieved, and their relevant characteristics were extracted and analyzed. In total, 895 pediatric clinical trials were collected, accounting for 5.1% of the total registered clinical trials initiated prior to January 1, 2023. The overall average annual growth rate for the number of pediatric clinical trials was 12% (P < 0.001). Phase III trials accounted for the highest proportion (49.1%, 439). Of the 895 trials included, 736 (82.2%) were domestic trials, and 159 (17.8%) were international multicenter trials. In terms of tested drugs, investigations of biological products accounted for the largest proportion of trials (67.4%, 603). Among pediatric clinical trials, studies of vaccines accounted for the largest proportion of trials (41.0%, 367), followed by trials for rare diseases (17.2%, 154). Furthermore, geographical distribution analysis revealed that the largest and smallest numbers of trials were conducted in North China (35.7%, 320) and Northeast China (0.8%, 7), respectively. The growth trends for industry-sponsored clinical trials involving children illustrate the progress and increasing capability of pediatric drug development achieved in China since 2013. Current challenges and potential areas of focus for policymakers and stakeholders include investigating orphan drugs for rare diseases according to the unique epidemiological characteristics of Chinese children, expanding the scope of pediatric clinical trials, and improving the uneven geographical distribution of leading research centers.

From Research to Application of Wearable-Derived Digital Health Measures—A Perspective From ActiGraph

ActiGraph counts were first conceptualized in 1996 to provide an accelerometer-derived metric that can quantify physical activity based on intensity. ActiGraph incorporated this metric into its product suite, enabling its wide adoption in research studies. Over the last 20 years, ActiGraph activity counts have become one of the most common metrics and building blocks of health outcome measures used in wearable research, with &gt;24,000 journal articles published (based on Google Scholar search in 2023). Recently, this field of research is increasingly moving toward clinical application where wearable-derived metrics are growing in industry-sponsored clinical trials, including several use cases endorsed by the regulatory authorities. We celebrate this emerging trend as these patient-generated measures help reduce trial burden and enhance the meaningfulness of developed medical products to the patients. However, true adoption of digital measures in industry research is only in its infancy and still faces many challenges. As a digital health technology provider, ActiGraph has launched several strategic initiatives to support the research community to overcome these challenges and accelerate the translation of research to clinical application. The open-source release of the ActiGraph count algorithm was one of those initiatives. In this commentary, we take the opportunity to share our perspective in supporting the research community with this metric over the last 20 years, the motivation for making this open source, and what we are building to accelerate clinical adoption and realize the promise of better patient care.

Diversity in Oncology Clinical Trials: Current Landscape for Industry-Sponsored Clinical Trials in Asia.

There has been a growing recognition on the importance of diversity in clinical trials. Existing research has highlighted a significant demographic imbalance. Amidst this renewed focus on diversity, it is crucial to acknowledge that Asia comprises over half of the world's population. Given the region's demographic significance, we sought to compare various characteristics and growth rates for trials with sites in Asia against those without any sites in Asia. We performed comprehensive analyses of industry-sponsored phase 2 and 3 oncology trials registered at Clinicaltrials.gov, using drugs or biologics as investigational agents and executed between 1 January 2018 and 31 December 2022. We applied the compound annual growth rate (CAGR) as an analytical tool to track the trial growth rates over this 5-year period. We identified 894 industry-sponsored phase 2 and 3 cancer studies with available study location data. Out of these, 415 trials (46.42%) had study sites in Asia. Notably, these trials with sites in Asia were also more likely to be phase 3 trials (39.76% vs 6.47%, p < 0.001), include female and paediatric populations, and be randomised trials. Interestingly, lung and stomach cancers were more commonly studied in these trials, while myeloma was less commonly studied. The number of trial sites for liver cancer was not significantly higher for Asia, even though the incidence of the disease is much higher in this region. Despite an overall declining trend in the number of clinical trials in the last 5 years, we observed a transitional positive increase in the CAGR from 2020 to 2021 for trials with sites in Asia. However, East Asia, specifically China, exhibited a disproportionate overrepresentation in these trials. There are notable characteristics of clinical trials with sites in Asia. Comprehending these disparities may aid in the strategic planning to enhance a balanced representation of ethnicities in trials.

Socioeconomic and Regional Disparities in Industry-Sponsored Clinical Trials in Multiple Sclerosis

This cross-sectional study examines the geographical and socioeconomic factors associated with trial distribution and outcome of treatment for multiple sclerosis (MS).

Industry-Sponsored Research Payments to Gastroenterologists and Hepatologists in the United States Between 2014 and 2021.

Aim This cross-sectional study aimed to examine the scale and trends of industry-sponsored research payments to gastroenterologists and hepatologists in the United States from 2014 to 2021. Methods Using the Open Payments Database and the National Plan and Provider Enumeration System (NPPES), the study analyzed both grant and research payments made to individual gastroenterologists and associated payments made for research where gastroenterologists and hepatologists served as principal investigators. Results After adjusting for inflation, the study found that a total of $1.5 billion was allocated to gastroenterologists by 284 companies during this period. Only 15.9% of the 20,986 gastroenterologists received at least one research payment, with associated research payments accounting for 97.6% of all payments. The study also revealed a significant increase in the number of gastroenterologists receiving associated research payments and a more than twofold increase in payments for registered clinical trials from 2014 to 2021. Conclusion The healthcare industry allocated large amounts of research funding to gastroenterologists and hepatologists. The study underscores the critical role of industry-sponsored clinical trials in advancing gastroenterological research and treatments.

As bleak as it sounds? Analyzing trends in oncology clinical trial initiation in the United Kingdom from 2013 to 2022.

93 Background: Clinical trials, especially phase 3 randomized clinical trials (RCTs), inform the standard of care in oncology, and their availability is the first step in ensuring opportunities for patient participation.A recent study by the Association of the British Pharmaceutical Industry showed a sharp decline in industry-sponsored clinical trials being performed in the United Kingdom (UK) over the past 5 years. In this study we sought to focus on UK participation in phase 3 RCTs of systemic anti-cancer therapy, both industry- and non-industry-sponsored, to evaluate if this decline applies more broadly to all phase 3 RCTs in the UK, especially within the context of Brexit in 2020. Methods: Data were identified and downloaded from ClinicalTrials.gov (CT.gov), a registry of privately and publicly funded clinical studies conducted globally, on March 14, 2023. Completed and recruiting trials with a start date on or after January 1, 2013, were identified using the keywords “neoplasms” and “cancer” and limited to “Phase 3”. Trials of supportive interventions or purely loco-regional interventions e.g., surgery, were excluded, as were randomized phase 2 trials. Eligible trials were categorized by year of commencement, participating countries, and the primary sponsor (e.g., industry or non-industry, including academic and cooperative groups). Results: 2345 of 3849 identified trials met the study eligibility criteria. The number of studies open in the UK increased from 48 in 2013 to 77 in 2021 but decreased to 49 in 2022. The number of UK trial sites included 383 in 2013 and decreased to 259 in 2022. Industry sponsored studies remained steady each year from 2017 to 2021 from 71 to 74 followed by a decline to 45 in 2022. In the European Union, excluding the UK, the number of open studies was 93 in 2013 and increased to 127 in 2021, but dropped to 93 in 2022. Combined trials in the US and Canada increased from 67 in 2013 to 105 in 2022. Conclusions: Clinical trials offer patients an avenue to experimental drugs and therapeutic combinations. Previous reports have raised concern that the UK has had precipitous drops in clinical trial initiation and enrollment secondary to the evolving regulatory landscape driven by concern about changes to the regulatory process and disharmonization due to Brexit. Our study highlights a reduction in clinical trials in the UK, however, this is consistent with declines in trial initiation across the EU, suggesting other factors (e.g., COVID-19) may be contributing factors. Paradoxically, trial initiation in the US and Canada increased over the same timeframe.[Table: see text]

Factors that influence clinical trial participation for oncology patients in Australia: A scoping review.

111 Background: Equity in clinical trials is a key priority for the health ecosystem and research community. Although participating in clinical trials has well documented benefits, enrolment rates remain a global challenge. Despite a modest population, Australia is competitive in the international clinical trial sphere, contributing 5% of industry-sponsored clinical trial activity globally. However, the factors that impact participation remains unknown in Australia. Our scoping review aims to assess factors that influence clinical trial participation by oncology patients in Australia. Methods: This scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) methodology and followed the PRISMA-ScR reporting guidelines. Searches were undertaken of four electronic databases and grey literature platforms. Two independent reviewers screened articles based on abstract and title followed by full text using pre-defined inclusion criteria. Data was extracted from the included articles by two reviewers independently, utilising a preformed data extraction tool. Characteristics of included articles were summarized using descriptive statistics. Extracted data underwent qualitative analysis. Results: Of 1010 identified references, 649 underwent title and abstract screening. Forty-six articles were reviewed in full text and 36 articles were included in the final analysis. The number of studies significantly increased over time which reflects the growing interest in this field. Cross-sectional surveys of patients and or health care professionals (HCP) were the most popular study design. Four key themes were derived: (1) Factors relating to patients, (2) factors relating to health care professionals, (3) factors relating to clinical trials, and (4) factors relating to health services. While self-reported patient willingness was consistent across various sociodemographic backgrounds, this contrasted with studies reporting lower participation rates in minority groups. HCP were keen to be involved in clinical trials, but limited support in resources appeared to a barrier. Contrasting with international literature, finances were uncommonly reported as a barrier to participation. Furthermore, international literature highlights trial availability and study eligibility criteria as major barriers to participation, this has not been explored in the Australian context. Conclusions: Addressing disparities in cancer clinical trials requires foundational knowledge of the factors that influence cancer clinical trial participation. Along with the developing body of the international literature, this scoping review provides a unique perspective through the Australian lens. Together, we can use this understanding to tailor our strategies and only then, can we improve equity, diversity, and inclusion in cancer clinical trials.

5 Cognitive, Emotional, and Functional Predictors of Clinical Trial Enrollment

Objective:With participant recruitment being a top barrier to AD research progress, the rate of screen failure in Alzheimer’s disease (AD) clinical trials is unsustainable. Although steps have been undertaken to consider solutions to the continued recruitment shortage, there is unfortunately minimal emphasis on reducing screen failure rates based on study inclusion criteria. Here we present information attempting to understand the cognitive, emotional, and functional features of individuals who failed screening measures for AD trials.Participants and Methods:The current study is a retrospective, cross-sectional analysis. Thirty-eight participants (aged 50-83) having (1) previously received a clinical diagnostic workup at a transdisciplinary cognitive specialty clinic and (2) previously screened for a specific industry-sponsored clinical trial of MCI/early AD (EMERGE) met inclusion criteria. Previously collected clinical data were analyzed to identify predictors of AD trial screen pass/fail status.Results:Of the 38 participants in the current study, 14 screen passed into this AD clinical trial, and 24 screen failed. Higher screen failure rates were significantly related to gender, with 83% of female participants screen failing this AD trial versus 45% of male participants. There was no difference in age or education between screen pass/fail groups, nor were differences present for performance on visual or verbal memory tasks, or the MOCA. Conversely, those participants screen failing this AD clinical trial performed significantly worse on nonmemory cognitive domains pertaining to general fund of knowledge, working memory, and executive functioning. Additionally, the screen fail group reported greater levels of anxiety, but not depression nor endorsements on a measure of functional status.Conclusions:Worse performance on non-memory neuropsychological domains was related to screen failure status for the EMERGE AD clinical trial. This finding may be explained by the traditional recruitment pathway from clinic to trials, which beyond the diagnosis of interest is up to the opinion of the physician to determine “fit” for a trial. Higher screen failure rates may result from physicians erroneously viewing more globally-impaired patients as being more appropriate for an AD clinical trial, resulting in greater tendencies towards recruiting patients who are too severe to meet inclusion criteria for a trial. Recruiting patients into clinical trials earlier in their disease course - when disease severity is less - may result in reduced screen failure rates in AD trials. That we could not detect a relationship between memory-related tasks and screen fail/pass status may be explained by either (1) the measures used in the EMERGE trial were not as sensitive to subtle changes in memory, or (2) that memory dysfunction is necessary for a diagnosis of AD but not sufficient to distinguish who will be successfully screened into an AD clinical trial. Overall, these findings have the potential to advance the field by reducing screen failure rates in AD clinical trials by using information already available to clinical trial teams, which will enhance trial-recruitment infrastructure and encourage greater engagement of older adults in AD research.

Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages

The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be realized. To assess the utility and completeness of IPD and supporting documents provided from industry-sponsored clinical trials. From February 9, 2022, to February 9, 2023, 91 of 203 clinical trials supporting US Food and Drug Administration registrations of anticancer medicines for the treatment of solid tumors from the past decade were confirmed as eligible for IPD request. This quality improvement study performed a retrospective audit of the utility and completeness of the IPD and supporting documents provided from the 91 clinical trials for a planned meta-analysis. Request for IPD from 91 clinical oncology trials indicated as eligible for the request. The utility and completeness of the IPD and supporting documents provided. The IPD packages were obtained from 70 of 91 requested clinical trials (77%). The median time to data provision was 123 (range, 117-352) days. Redactions were observed in 18 of the acquired IPD packages (26%) for outcome data, 11 (16%) for assessment variables, and 19 (27%) for adjustment data. Additionally, 20 IPD packages (29%) lacked a clinical study report, 4 (6%) had incomplete or missing data dictionaries, and 20 (29%) were missing anonymization or redaction description files. Access to IPD from 21 eligible trials (23%) was not granted. In this quality improvement study, there was substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.

Globalisation of industry-sponsored clinical trials for breast, lung and colon cancer research: trends, threats and opportunities

ObjectiveBreast, lung, colon cancers are the ‘big killers’ in oncology. Access to innovative treatments lags behind in low-income and middle-income countries. We investigated the geographic distribution of industry-sponsored trials; and...

Carbon footprint of industry-sponsored late-stage clinical trials

ObjectivesTo quantify the carbon footprint from a sample of pharma industry sponsored phase III trials. To develop an approach that can readily be applied to future trials by AstraZeneca and...

The value of clinical trial medication and yearly medicine cost avoidance from clinical trials conducted by the pharmaceutical industry in Finland

Background: Clinical trials have been reported to cause medication cost avoidance (MCA) for hospitals and societies, but there are no studies documenting MCA from the Nordic countries or from the pharmaceutical industry perspective. Methods: Three different methods were tested for determining the yearly MCA in clinical trials conducted by the pharmaceutical industry in Finland. MCA was evaluated with questionnaires to pharmaceutical companies operating in Finland in 2001, 2009 and 2013. Results: In method 1 (year 2001), the MCA in Finland was 70.3 million euros in wholesale price and 50.9 million euros when excluding patients receiving placebo treatment. In method 2 (2009), the MCA was 52.0 million euros in wholesale price and 71.0 million euros in out-sale price i.e. including pharmacy fee and tax. The MCA in method 3 (2013) was 47.2 million euros in wholesale price. The collection of data and the MCA calculation was simple in method 1 (response rate 100%). The methods 2 and 3 were more precise but more time-consuming for the respondents, somewhat affecting the response rate (response rates 90% and 72%, respectively). Conclusions: All three methods covered the majority of industry-sponsored clinical medicine trials (64-100%) representing 59-63 % of all clinical trials conducted in Finland in those years. Regardless of the methods, the study medications provided by the pharmaceutical industry promoted significant cost saving for the society. We recommend method 1 for a general and less time consuming MCA calculation and method 3 for a more precise calculation, to be conducted in survey format and interview.

The financial burden associated with endovascular repair of thoracoabdominal and pararenal aortic aneurysms using physician-modified fenestrated-branched endografts

Objective/BackgroundEndovascular thoracoabdominal and pararenal aortic aneurysm repair is more complex and requires more devices than infrarenal aneurysm repair. It is unclear if current reimbursement covers the cost of delivering this more advanced form of vascular care. The objective of this study was to evaluate the economics of fenestrated-branched (FB-EVAR) physician-modified endograft (PMEG) repairs. MethodsWe obtained technical and professional cost and revenue data for four consecutive fiscal years (July 1, 2017, to June 30, 2021) at our quaternary referral institution. Inclusion criteria were patients who underwent PMEG FB-EVAR in a uniform fashion by a single surgeon for thoracoabdominal/pararenal aortic aneurysms. Patients in industry-sponsored clinical trials or receiving Cook Zenith Fenestrated grafts were excluded. Financial data were analyzed for the index operation. Technical costs were divided into direct costs that included devices and billable supplies and indirect costs including overhead. Results62 patients (79% male, mean age: 74 years, 66% thoracoabdominal aneurysms) met inclusion criteria. The mean aneurysm size was 6.0 cm, the mean total operating time was 219 minutes, and the median hospital length of stay was 2 days. PMEGs were created with a mean number of 3.7 fenestrations, using a mean of 8.6 implantable devices per case. The average technical cost per case was $71,198, and the average technical reimbursement was $57,642, providing a net negative technical margin of $13,556 per case. Of this cohort, 31 patients (50%) were insured by Medicare remunerated under diagnosis-related group code 268/269. Their respective average technical reimbursement was $41,293, with a mean negative margin of $22,989 per case, with similar findings for professional costs. The primary driver of technical cost was implantable devices, accounting for 77% of total technical cost per case over the study period. The total operating margin, including technical and professional cost and revenue, for the cohort during the study period was negative $1,560,422. ConclusionsPMEG FB-EVAR for pararenal/thoracoabdominal aortic aneurysms produces a substantially negative operating margin for the index operation driven largely by device costs. Device cost alone already exceeds total technical revenue and presents an opportunity for cost reduction. In addition, increased reimbursement for FB-EVAR, especially among Medicare beneficiaries, will be important to facilitate patient access to such innovative technology.

PCR74 Trends in the Inclusion of Patient Reported Outcomes in Oncology Clinical Trials: Analysis of ClinicalTrials.gov (2013-2022)

FDA continues to advocate for including patient voice in drug development with the release new guidances over the last 5 years. Industry continues to invest heavily in development of new treatments for oncology. Our study aims to describe the trends in inclusion of patient reported outcomes (PROs) in industry-sponsored oncology clinical trials over the last 10 years.

Source of funding and enrollment disparity in cancer clinical trials.

6559 Background: Recent findings that Black and Hispanic patients were significantly underrepresented in industry-sponsored prostate cancer trials warrant a detailed investigation across cancer types to assess the association between funding source and enrollment disparities. Methods: Phase II/III clinical trials in prostate, breast, colorectal, and lung cancers reporting age, gender, race/ethnicity, and reporting NIH or industry as the funding source were considered eligible for inclusion. For age, and gender analysis, all trials were considered eligible. For race/ethnicity analysis, trials recruiting from the United States (US) were considered eligible. Enrollment-incidence ratios (EIR) comparing trial proportion from age/gender or racial/ethnic subgroups against global cancer incidence in the corresponding group (from Global Burden of Disease) or US-population-based incidence in the corresponding racial/ethnic subgroup (from SEER 22), were computed. Trial-level EIRs were pooled using a random-effects model and subsequently stratified by funding source. A univariate meta-regression was conducted to assess the temporal changes in EIR by each funding category. Results: Of 42,390 studies initially identified, 2234 trials (1989-2021) met the eligibility criteria. Regarding age, 361 (16%) trials reported age categories by 65 years threshold. Of 698 trials recruiting from the US, 498 (71%) reported race, and 198 (28%) reported ethnicity. Regarding representation, older adults were under-represented (EIR: 0.66; 95% CI: 0.62-0.70) in the industry but not in NIH-sponsored clinical trials (0.79; 0.62-1.00). Regarding gender, no significant disparity was observed regarding the enrollment of men and women in colorectal and lung cancer clinical trials. In terms of race, there was a greater under-representation of Black patients in industry sponsored trials (0.29; 0.26-0.32) as compared to NIH-sponsored clinical trials (0.65; 0.57-0.74) [Pint &lt;0.01]. Asian patients were significantly overrepresented in industry sponsored trials (3.17; 2.69-3.74) but not in NIH sponsored clinical trials (1.43; 0.85-2.41) [Pint &lt;0.01]. Hispanic patients were significantly under-represented in both, industry (0.27; 0.22-0.34) and NIH-sponsored clinical trials (0.35; 0.22-0.55) [Pint 0.32]. Secondary analyses including trials recruiting exclusively from the US, and analyses by specific cancer types showed consistent results. Recruitment of older adults, men, and Black patients is decreasing over time. Conclusions: There is a consistent under-representation of older adults in industry-sponsored, and of Black and Hispanic patients in both industry-sponsored and NIH-sponsored clinical trials. The under-representation of Black patients is likely to be greater in industry-sponsored trials, which has worsened over the last three decades.

The implementation of a diverse clinical trial program at a rural community cancer center over a 10-year period.

e18559 Background: The state of Mississippi ranks last or close to last in the majority of health outcomes including cancer outcomes due to health disparities. Health disparities are worse for patients who face obstacles due to race, socio-economic status, or geographical exclusion. Improving minority enrollment in clinical trials allows for improved cancer care. We report the implementation of an inclusive and diverse clinical trial program at a community cancer center in rural Mississippi over a 10-year period of time. Forrest General Cancer Center cares for patients in a 19 county area with a diverse patient population consisting of 72.8% White, 25.8% Black, and 1.4% Other. Methods: We reviewed the patient database of our clinical trial program over a 10-year period of time from January 1, 2013, through December 31, 2022. All patients enrolled on clinical trials during this period were included in our analysis. We collected data regarding types of clinical trials, racial demographics, patient age, and primary sight of malignancy. A two proportion Z-test was utilized to analyze any differences between race in the study group and cancer population as a whole. A 2 tailed P value was then calculated. Results: During the 10-year period, 242 patients successfully enrolled onto clinical trials. 227 (93.80%) patients were enrolled on interventional treatment studies, and 15 (6.19%) patients were enrolled on registration studies. 233 (96.28%) patients were enrolled on pharmaceutical sponsored trials as opposed to 9 (3.72%) patients enrolled on cooperative group trials. 180 (74.4%) patients were White, 62 (25.6%) patients were identified as minority patients including 60 (24.8%) Black patients, and 2 (0.8%) Asian patients. There was no statistical difference between the racial diversity of study patients compared to baseline patient demographics (P = 0.608318). The average age of enrollment was 61.85 years (range 24-89). The average age for White patients was 63.06 years, and the average age for Black patients was 57.77 years. The most common malignancies included Breast 91 (37.6%), Lung 63 (26.0%), Hematolymphoid 41 (16.9%), Colon 16 (6.6%), Head and Neck 10 (4.1%), and Melanoma 5 (2.1%). Conclusions: We have demonstrated the successful implementation of an Oncology clinical trial program in rural Mississippi leading to advanced patient care with increased availability to high-quality clinical trials. During this time period, we have successfully enrolled a diverse population accurately representing our patients under our care. We feel that our model can successfully be implemented at cancer centers caring for underserved and minority patients throughout the United States leading to improved patient care in these populations. We have shown that it is possible to have a successful clinical trial program with primarily industry sponsored clinical trials in a community cancer center.

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials.

An informed consent form is essential in drug development clinical trials. This study aimed to evaluate regulatory compliance and readability of informed consent forms currently being used in industry-sponsored drug development clinical trials. This descriptive, cross-sectional study evaluated the informed consent forms of industry-sponsored drug development clinical trials conducted at the Faculty of Medicine, Chiang Mai University, between 2019 and 2020. The informed consent form's compliance with the three major ethical guidelines and regulations (i.e. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use E6(R2) Good Clinical Practice; Declaration of Helsinki; and the revised Common Rule) were analyzed. The document length and the readability scores (using Flesch Reading Ease and Flesch-Kincaid Reading Grade) were assessed. Of 64 reviewed informed consent forms, the average page length was 22.0 ± 7.4 pages. More than half of their length was mainly devoted to three elements: trial procedures (22.9%), risks and discomforts (19.1%), and confidentiality and the limit of confidentiality (10.1%). Although most of the required elements of the informed consent form content were included in most informed consent forms, we identified four elements with often missing information in the form: aspects of research that are experimental (n = 43, 67.2%), involvement of whole-genome sequencing (n = 35, 54.7%), commercial profit sharing (n = 31, 48.4%), and posttrial provisions (n = 28, 43.8%). The informed consent forms in industry-sponsored drug development clinical trials were long but incomplete. Our findings draw attention to ongoing challenges in industry-sponsored drug development clinical trials, where deficient informed consent form quality continues to exist.

Association Between Industry Sponsorship of Spine-Related Clinical Trials, Publication Status, and Research Outcomes.

Observational Database Study. Prospective clinical trials in spinal surgery are expensive to conduct, especially when randomized, appropriately powered, and/or multicentered. Industry collaborations generate symbiotic relationships promoting technological advancement; however, they also allow for bias. To the authors' knowledge, there is no known analysis of correlations between industry sponsorship and publication rates of spine-related clinical trials. This observational work evaluates such potential associations. The ClinicalTrials.gov database was queried with terms spine, spinal, spondylosis, spondylolysis, cervical, lumbar, and compression fracture over an 11-year period. Design characteristics and outcomes were recorded from 822 spine surgery-related trials. Trials were stratified based on funding source and intervention class. Groups were compared via two-tailed chi-square test of independence or Fisher's exact test (α = .05), based on completion status and publication rates of positive vs negative results. Industry-sponsored spine-related clinical trials were more likely to be terminated than their non-industry-sponsored counterparts (P < .001). Of the trials achieving publication, industry-sponsored trials reported positive results at a higher rate than did trials without industry funding (P = .037). Clinical trials examining devices were more likely to be terminated than those studying other intervention classes (P = .001). High termination rates and positive result publication rates among industry-sponsored clinical trials in spinal surgery likely reflect industry's influence on the research community. Such partnership alleviates financial burden and provides accessibility to cutting-edge innovation. It is essential that all parties remain mindful of the significant bias that funding source may impart on study outcome.