Contemporary Clinical Trials Communications最新文献

Background

The successful completion of clinical trials ultimately depends on realistic recruitment predictions. Statistical methods for recruitment prediction implemented in a free-of-charge open-source software could be routinely used by researchers worldwide to design clinical trials. However, the availability of such software implementations is currently unclear.

Methods

Two independent reviewers conducted a systematic review following PRISMA guidelines. Eligible articles included English publications focused on statistical methods for recruitment prediction and monitoring that referred to software implementations. The list of articles retrieved from well-established data bases was enriched by backtracking of references provided by eligible articles. The current software availability and open-source status were tabulated.

Results

We found 21 eligible articles, 7 of which (33 %) provide freely accessible software. Ultimately, only one article provides a link to an easy-to-comprehend, well-documented, and currently directly applicable free-of-charge open-source software. The lack of availability is mainly caused by blocked access and outdated links.

Conclusions

While several software implementations exist for recruitment prediction, only a small fraction is freely accessible. These results highlight the need for future efforts to achieve free access to well-documented software implementations supporting researchers in routinely using statistical methods to arrive at realistic recruitment predictions in clinical trials.

Background

Awake prone position (APP) has been reported to improve oxygenation in patients with COVID-19 disease and to reduce the requirement for invasive mechanical ventilation for patients requiring support with high flow nasal cannula. There is conflicting data for patients requiring lower-level oxygen support.

Research question

Does APP reduce escalation of oxygen support in COVID-19 patients requiring supplementary oxygen?The primary outcome was defined as an escalation of oxygen support from simple supplementary oxygen (NP, HM, NRB) to NIV (CPAP or BiPAP), HFNC or IMV; OR from NIV (CPAP or BiPAP) or HFNC to IMV by day30.

Study design

Two center, prospective, non-blind, randomised controlled trial. Patients with confirmed or suspected COVID-19 pneumonia requiring ≥ 5 liters/min oxygen to maintain saturations ≥ 94 % were randomised to either APP or control group. The APP group received a 3-h APP session three times per day for three days.

Results

Between 9 May and July 13, 2021, 89 adults were screened and 61 enrolled, 31 to awake prone position and 30 controls. There was no difference in the primary outcome, 7 (22.6 %) patients randomised to APP and 9 (30.0 %) controls required escalation of oxygen support (OR 0.68 (0.22–2.14), P = 0.51). There were no differences in any secondary outcomes, in APP did not improve oxygenation.

Interpretation

In COVID-19 patients, the use of APP did not prevent escalation of oxygen support from supplementary to invasive or non-invasive ventilation or improve patient respiratory physiology.

Trial registration

NCT04853979 (clinicaltrials.gov).

Involving diverse populations in early-phase (phase I and II) cancer clinical trials is critical to informed therapeutic development. However, given the growing costs and complexities of early-phase trials, trial activation and enrollment barriers may be greatest for these studies at healthcare facilities that provide care to the most diverse patient groups, including those in historically underserved communities (e.g., safety-net healthcare systems). To promote diverse and equitable access to early-phase cancer clinical trials, we are implementing a novel program for the transfer of care to enhance access to early-phase cancer clinical trials. We will then perform a mixed-methods study to determine perceptions and impact of the program. Specifically, we will screen, recruit, and enroll diverse patients from an urban, integrated safety-net healthcare system to open and active early-phase clinical trials being conducted in a university-based cancer center. To evaluate this novel program, we will: (1) determine program impact and efficiency; and (2) determine stakeholder experience with and perceptions of the program. To achieve these goals, we will conduct preliminary cost analyses of the program. We will also conduct surveys and interviews with patients and caregivers to elucidate program impact, challenges, and areas for improvement. We hypothesize that broadening access to early-phase cancer trials conducted at experienced centers may improve equity and diversity. In turn, such efforts may enhance the efficiency and generalizability of cancer clinical research.

The Food and Drug Administration (FDA) has recommended that clinical trial study populations accurately reflect the patients likely to use the product, if approved. The FDA has not provided specific guidance on how cohort sizes of clinically relevant demographic characteristics should be determined. Therefore, the present study was designed to compare demographic characteristics reported in US-only FDA approval trials to the demographic characteristics of the related medical disorders in an electronic health records database of >150 M patients in the United States (US). The results demonstrate that comparative disparities in demographic cohort proportions are common, yet inconsistent, and highlight the need to define disorder specific demographic cohort proportion goals in future clinical trials.

Objectives

Radiation-induced dermatitis (RD) is one of the most common toxicities in radiation therapy (RT) patients. Corticosteroids, immunosuppressants, and natural products (NPs) have been used as treatment. The objective was to evaluate the efficacy of a NPs-based cream (Alantel®) to reduce the incidence of RD in women with breast cancer undergoing RT treatment.

Design

We conducted a controlled, randomized, double-blind clinical trial.

Setting

Radiation Oncology Unit of the Reina Sofía Hospital and 5 Primary Care centers of the Cordoba and Guadalquivir Health District (Spain).

Interventions

Patients assigned to the experimental group (GTA) were treated with Alantel, while those in the control group (GTE) were treated with a moisturizer and emollient cream.

Main outcome measures

The primary outcome variable was the incidence of RD. RD-free time, duration of RD, quality of life, and product safety were also assessed.

Results

Seventy patients were included in the study, 35 in the GTA and 35 in the GTE. The incidence of RD was lower in the GTA (71.4%) than in the GTE (91.4%) after 4 weeks of follow-up (RR = 0.78; NNT = 5; p < 0.031). The Skindex-29 questionnaire showed differences in the statement: “My skin condition makes it hard to work or do hobbies” (17.1% in the GTE vs. 2.9% in GTA; p = 0.024).

Conclusions

The higher efficacy of Alantel® compared to the control cream in reducing the incidence of RD in women with breast cancer has been demonstrated.

Pre-menstrual disorders, including pre-menstrual syndrome and pre-menstrual dysphoric disorder, are highly prevalent disorders in women of reproductive age. Pre-menstrual disorders are associated with debilitating symptoms that onset in the days prior to menses. A complex interplay between hormonal fluctuations, cellular sensitivity, and psychosocial stressors likely underly the pathophysiology of pre-menstrual disorders. Current treatment options include selective serotonin reuptake inhibitors, hormonal therapies, and psychosocial support. There is growing evidence for oestrogen, progesterone, gonadotropin Releasing Hormone analogues and Complementary and Alternative Medicines in treating Pre-menstrual disorders. (S)–S-adenosylmethionine is a complementary and alternative medicine with postulated roles in the treatment of depression, with a rather rapid onset of action and minimal side effect profile. We propose a protocol for investigating the efficacy of (S)–S-adenosylmethionine in the treatment of pre-menstrual disorders. The proposed study is an open label pilot study, that will recruit thirty women between the ages of 18–45 who experience a pre-menstrual disorder. Daily and interval questionnaires will provide a quantification of symptoms across four menstrual cycles (16 weeks). During two consecutive menstrual cycles it is proposed that participants receive oral (S)–S-adenosylmethionine Complex 400 mg three times a day (total daily dose 1200 mg), during the pre-menstrual time-period (14 days prior to menses). Changes in pre-menstrual disorder symptoms between control and treatment cycles will assist in elucidating the clinical efficacy of (S)–S-adenosylmethionine. This study has the potential to support a larger double blinded, placebo controlled randomised control trial and aims to enrich the knowledge surrounding pre-menstrual disorders.

Background

Current health behavior recommendations for skin cancer prevention, treatment, and survivorship are the same for survivors of other cancers; they include eating a healthy diet, being physically active, maintaining a healthy weight, and minimizing ultraviolet (U.V.) exposure. Few interventions exist to support health behaviors beyond U.V. exposure. We adapted Harvest for Health, a home-based mentored gardening intervention for cancer survivors, for implementation in Arizona as a community-based intervention.

Methods

Stakeholder-informed adaptations for Harvest for Health Together Arizona (H4H2-AZ) included updating intervention materials to be relevant to the arid desert environment, emphasizing the importance of sun safety in cancer survivorship, and shifting from a home-based to a community-based delivery model. Participants will be enrolled in cohorts aligned with growing seasons (e.g., spring, monsoon, fall) and matched to an individual 30 ft² community garden plot for two growing seasons (6 months). Original intervention components retained are: 1) Master Gardeners deliver the intervention providing one-to-one mentorship and 2) gardening materials and supplies provided. This pilot six-month single-arm intervention will determine feasibility, acceptability, and appropriateness of an evidence-based adapted mentored community gardening intervention for survivors of skin cancer as primary outcomes. Secondary outcomes are to explore the effects on cancer preventive health behaviors and health-related quality of life.

Discussion

This pilot single-arm intervention will determine feasibility, acceptability, and appropriateness of an evidence-based adapted mentored community gardening intervention for survivors of skin cancer. If successful, the intervention could be widely implemented throughout existing Master Gardener programs and community garden networks for survivors of other cancers.

Trial registration

ClinicalTrials.gov identifier: NCT05648604. Trial registered on December 13, 2022.

Background

Habitual physical activity (PA) and exercise form a cornerstone of the management of cystic fibrosis (CF), a genetically inherited pulmonary and digestive condition – whereby telehealth platforms have been proposed as a mechanism to engage remotely people with CF in PA and exercise.

Methods

To test this, in early 2020, the ‘ActivOnline: Physical Activity in Cystic Fibrosis Trial’ (ActiOn PACT) randomised control trial was established to examine whether an online intervention was effective at increasing PA in adolescents and adults with CF.

Results

The emergence of the COVID-19 pandemic in 2020 forced this trial to be paused and modified, with the adoption of online recruitment and remote assessment of outcome measures. Despite such adaptations in accord with frameworks developed by the National Institute for Health Research, this trial failed to recruit and was subsequently terminated.

Conclusions

This article details the authors reflections upon the proposed reasons for lack of recruitment, including improved technology and medications for people with CF, and contextualises this finding in relation to the wider issue of non-reporting of trial results in clinical research.

Background

Engaging diverse populations in clinical trials is vital to research. This study evaluated the effects of varying recruitment messages for a clinical trial.

Methods

The messages were evaluated in a randomly assigned, factorial design that tested enhanced trust (vs. standard) and participant endorsement (vs. standard) messaging.

Four postcards were developed and randomly assigned to 4000 potential participants' addresses. Except for the messages of interest, the cards were identical, and participants were directed to four identical study websites and screening forms. Outcomes include unique website visits, visit conversion rate, screening forms completed, and participants randomized into the parent study.

Results

Study websites received 74 visits (range by message type 9 to 34). There was no significant difference by message type (p = 0.79). Online screening forms were completed by 15 participants (range by message type 0–6), representing a conversion rate of 20.3% of website visits. Seven participants were randomized into the study in response to the postcards (range by message type 0 to 3; 46.7% of screenings). Overall, 0.2% of individuals who received a postcard were randomized into the study.

Conclusion

Despite developing recruitment messages with participant input, the enhanced messages did not yield a greater response than standard messages. However, this method of evaluating recruitment messages shows promise.