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Article ; Online: How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Brian Perry / Lindsay Kehoe / Teresa Swezey / Quentin Le Masne / Jörg Goldhahn / Alicia Staley / Amy Corneli

Digital Biomarkers, Vol 7, Iss 1, Pp 45-

2023 Volume 53

Abstract: Introduction: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited. ... ...

Abstract	Introduction: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited. Methods: From November 2020 through March 2021, the Clinical Trials Transformation Initiative (CTTI) conducted a qualitative descriptive study using semi-structured interviews with sponsors of clinical trials that used DHT-derived endpoints. We aimed to learn about their experiences, including their interactions with regulators and the challenges they encountered. Using applied thematic analysis, we identified barriers to and recommendations for using DHT-derived endpoints in pivotal trials. Results: Sponsors identified five key challenges to incorporating DHT-derived endpoints in clinical trials. These included (1) a need for additional regulatory clarity specific to DHT-derived endpoints, (2) the official clinical outcome assessment qualification process being impractical for the biopharmaceutical industry, (3) a lack of comparator clinical endpoints, (4) a lack of validated DHTs and algorithms for concepts of interest, and (5) a lack of operational support from DHT vendors. Discussion/Conclusion: CTTI shared the interview findings with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and during a multi-stakeholder expert meeting. Based on these discussions, we provide several new and revised tools to aid sponsors in using DHT-derived endpoints in pivotal trials to support labelling claims.
Keywords	digital health technology ; regulatory trial ; endpoint ; clinical outcome assessment ; Biology (General) ; QH301-705.5
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	Karger Publishers
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Pediatric Trials Network

Amy Corneli / Brian Perry / Daniel K. Benjamin, Jr. / Kanecia O. Zimmerman

Contemporary Clinical Trials Communications, Vol 22, Iss , Pp 100792- (2021)

Stakeholder views on thanking families and providing study findings on pragmatic pediatric clinical research

2021

Abstract: We conducted formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric ... ...

Abstract	We conducted formative research using in-depth interviews to identify preferences for and anticipated responses to receiving thank you notes and lay summaries of aggregate results among caregivers and adolescent participants of pragmatic pediatric studies conducted by the National Institute of Health-sponsored Pediatric Trials Network. We analyzed the data using qualitative thematic analysis. Nearly all participants said receiving a thank you note would make them feel valued, appreciated, and proud because they contributed to science. Similarly, nearly all participants said that receiving a lay summary of research results would make them aware of their role in improving the lives of children, feel like they are an active partner in research, and believe that researchers want to keep them informed. Participants also said that receiving a thank you note or lay summary may motivate them to participate in future research. Providing thank you notes as part of study participation should become a standard clinical trial practice, similar to the practice of providing lay summaries.
Keywords	Lay summary ; Clinical trials ; Pediatric trials network ; Medicine (General) ; R5-920
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Biological weapons: an introduction for surgeons.

Brian Perry, W

The Surgical clinics of North America

2006 Volume 86, Issue 3, Page(s) 649–663

Abstract: Although the risk of an intentional biological weapon release is small for any one location, the chance that there will be an attack somewhere is real. Because surgeons will certainly be called on should this happen, they need to know the basics about ... ...

Abstract	Although the risk of an intentional biological weapon release is small for any one location, the chance that there will be an attack somewhere is real. Because surgeons will certainly be called on should this happen, they need to know the basics about the potential agents. This review covers the history of biological weapons,the major agents, and the possible specific roles for surgeons.
MeSH term(s)	Biological Warfare ; Bioterrorism ; Communicable Disease Control/organization & administration ; Disaster Planning ; Disease Outbreaks/prevention & control ; Humans ; Population Surveillance
Language	English
Publishing date	2006-06
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	215713-5
ISSN	1558-3171 ; 0039-6109
ISSN (online)	1558-3171
ISSN	0039-6109
DOI	10.1016/j.suc.2006.02.009
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs

Amy Corneli / Brian Perry / Andrea Des Marais / Yujung Choi / Hillary Chen / Rebecca Lilly / Denae Ayers / Jesse Bennett / Lauren Kestner / Christina S. Meade / Nidhi Sachdeva / Mehri S. McKellar

Harm Reduction Journal, Vol 19, Iss 1, Pp 1-

a qualitative descriptive evaluation

2022 Volume 11

Abstract: Abstract Background People who inject drugs (PWID) are at risk for HIV and opioid overdose. We piloted PARTNER UP, a telemedicine-based program to provide PWID with access to both oral pre-exposure prophylaxis (PrEP) for HIV prevention and medication for ...

Abstract	Abstract Background People who inject drugs (PWID) are at risk for HIV and opioid overdose. We piloted PARTNER UP, a telemedicine-based program to provide PWID with access to both oral pre-exposure prophylaxis (PrEP) for HIV prevention and medication for opioid use disorder (MOUD) through two syringe services programs (SSPs) in North Carolina. We conducted a qualitative evaluation to assess the acceptability and feasibility of PARTNER UP from the participant perspective. Methods PARTNER UP participants met with a provider for an initial in-person visit at the SSP, followed by weekly telemedicine visits in month 1 and then monthly telemedicine visits until program end at month 6. Using a qualitative descriptive study design, we conducted in-depth interviews with a subsample of PARTNER UP participants at 1 month and 4 months. Informed by the technology acceptance model, we assessed participant perceptions of the usefulness and ease of use of PARTNER UP, as well as their intent to continue to use the program’s components. We audio-recorded all interviews with participants’ permission and used applied thematic analysis to analyze the verbatim transcripts. Results We interviewed 11 of 17 people who participated in PARTNER UP—10 in the month 1 interview and 8 in the month 4 interview. Nearly all participants were motivated to join for consistent and easy access to buprenorphine/naloxone (i.e., MOUD); only a few joined to access PrEP. Most were comfortable accessing healthcare at the SSP because of their relationship with and trust toward SSP staff, and accessing services at the SSP was preferred compared with other healthcare centers. Some participants described that telemedicine allowed them to be honest and share more information because the visits were not in-person and they chose the location, although the initial in-person meeting was helpful to build provider trust and rapport. Most participants found the visit schedule to be feasible, although half described needing to reschedule at least once. Nearly all ...
Keywords	Pre-exposure prophylaxis ; HIV prevention ; People who inject drugs ; Medication for opioid use disorder ; Telemedicine ; Syringe services programs ; Public aspects of medicine ; RA1-1270
Subject code	150
Language	English
Publishing date	2022-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Developing lay summaries and thank you notes in paediatric pragmatic clinical trials

Kanecia O. Zimmerman / Brian Perry / Emily Hanlen‐Rosado / Adora Nsonwu / Morgan D. Lane / Daniel K. Benjamin / Mara Becker / Amy Corneli / Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee

Health Expectations, Vol 25, Iss 3, Pp 1029-

2022 Volume 1037

Abstract: Abstract Introduction Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you ...

Abstract	Abstract Introduction Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you notes, as well as to refine and expand guidance on participant and family engagement in Pediatric Trials Network's (PTN) pragmatic paediatric clinical research. Methods Informed by draft PTN guidance, we conducted in‐depth qualitative interviews with adolescent clinical trial participants and caregivers of paediatric participants in four trials conducted by PTN across eight sites. Participants were shown multiple versions of mock lay summaries and thank you notes and asked questions on their preferences for content and layout, and on trial communications. We used applied thematic analysis to analyse the data. Results We interviewed 27 individuals engaged in PTN research: 24 caregivers and 3 adolescents. During a trial, participants want regular updates on study progress, reminders of the study purpose and reassurances of data confidentiality. After the trial, participants want to learn the aggregated results, particularly medication effectiveness. Participants reported that lay summaries should include a review of the study's purpose, methods and length, and that they expect to learn individual‐level results. Participants stated that thank you notes must be of sufficient length to be meaningful. Conclusions This is the first study to describe stakeholder preferences for thank you note content and layout. Using these findings, we finalized PTN's trial communication guidance for use in future PTN trials. Research is needed to determine the effect of lay summaries and thank you notes on improving public transparency regarding clinical trials and paediatric trial recruitment and completion. Patient or Public Contribution By design, stakeholders (adolescent trial participants and caregivers of pediatric trial participants) contributed to PTN's guidance on the content ...
Keywords	clinical trials ; formative research ; lay summaries ; paediatrics ; Medicine (General) ; R5-920 ; Public aspects of medicine ; RA1-1270
Subject code	410 ; 306
Language	English
Publishing date	2022-06-01T00:00:00Z
Publisher	Wiley
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Chemotaxonomy of kōwhai: leaf and seed flavonoids of New Zealand Sophora species

McDougal, Owen Michael / John William van Klink / Nigel Brian Perry / Peter Brian Heenan

New Zealand journal of botany. 2018 July 3, v. 56, no. 3

2018

Abstract: Chemotaxonomic analysis of kōwhai leaf extracts in New Zealand are limited with previous reports of Sophora tetraptera having a flavonoid profile distinct from S. microphylla sensu lato and S. prostrata. Eight Sophora species are now recognised in New ... ...

Abstract	Chemotaxonomic analysis of kōwhai leaf extracts in New Zealand are limited with previous reports of Sophora tetraptera having a flavonoid profile distinct from S. microphylla sensu lato and S. prostrata. Eight Sophora species are now recognised in New Zealand: S. chathamica, S. fulvida, S. godleyi, S. longicarinata, S. microphylla, S. molloyi, S. prostrata and S. tetraptera. We now report liquid chromatography-ultraviolet-mass spectrometry (LC-UV-MS) analyses of leaf and seed extracts of individual plants (2–16) from each of these eight species, plus the Chilean S. cassioides. All of the S. tetraptera leaf extracts had similar LC-UV-MS profiles, different from all of the other Sophora samples, consisting of four predominant compounds, characterised by MS and nuclear magnetic resonance (NMR) spectroscopy as: luteolin-7-O-rutinoside 1, luteolin-7-O-glucoside 2, apigenin-7-O-rutinoside 3, and apigenin-7-O-glucoside 4. The other Sophora leaf extracts showed complex flavonoid compositions, with no clear distinction between species. Most of the Sophora seed samples, including those of S. tetraptera, showed one major phenolic compound, but a few had a related compound. These were purified and characterised by MS and NMR spectroscopy as 3′,4′,7-trihydroxyisoflavone 5 (in most seeds) and its 7-O-glucoside 6 (in a few seeds), neither of which has been previously reported from these Sophora species.
Keywords	chemotaxonomy ; flavonoids ; leaf extracts ; leaves ; liquid chromatography ; nuclear magnetic resonance spectroscopy ; seed extracts ; seeds ; Sophora ; New Zealand
Language	English
Dates of publication	2018-0703
Size	p. 227-236.
Publishing place	Taylor & Francis
Document type	Article
ZDB-ID	2098798-5
ISSN	1175-8643 ; 0028-825X
ISSN (online)	1175-8643
ISSN	0028-825X
DOI	10.1080/0028825X.2018.1472107
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: More than a box to check

Teresa Swezey / F. Hunter McGuire / Patricia Hurley / Janette Panhuis / Kathy Goldstein / Tina Chuck / Carrie Dombeck / Brian Perry / Christina Brennan / Natasha Phrsai / Amy Corneli

Contemporary Clinical Trials Communications, Vol 19, Iss , Pp 100606- (2020)

Research sponsor and clinical investigator perspectives on making GCP training relevant

2020

Abstract: Background: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist about whether the current structure and delivery of GCP training sufficiently prepares ... ...

Abstract	Background: Good clinical practice (GCP) training is the industry expectation for ensuring quality conduct of registrational clinical trials. However, concerns exist about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure quality conduct of clinical trials. Data were examined using applied thematic analysis. Results: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants’ health and safety. Respondents acknowledged that GCP principles address each of these critical tasks but also described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the perceived relevance of GCP training. Conclusion: Our findings indicate that although investigators and sponsors recognize that GCP training addresses tasks critical to the quality conduct of clinical trials, the need for significant improvement in the design, content, and presentation of GCP training remains.
Keywords	Good clinical practice ; Clinical trials ; Quality ; Investigator training ; Clinical investigator ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2020-09-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Facilitators of adherence to the study pill in the FEM-PrEP clinical trial.

Amy Corneli / Brian Perry / Kawango Agot / Khatija Ahmed / Fulufhelo Malamatsho / Lut Van Damme

PLoS ONE, Vol 10, Iss 4, p e

2015 Volume 0125458

Abstract: INTRODUCTION:FEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up ... ...

Abstract	INTRODUCTION:FEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up study to identify, among other topics, participants' reasons for taking the study pill. METHODS:Qualitative, semi-structured interviews (SSIs) were conducted with 88 FEM-PrEP participants. Participants were purposefully selected based on their adherence drug concentrations collected during FEM-PrEP and placed into three adherence interview groups: "high," "moderate," and "none/scarce." Participants in the high and moderate groups described reasons why they adhered most or some of the time, including factors that facilitated their adherence. Participants in all groups described what they believed made it possible for other FEM-PrEP participants to adhere. In addition, 224 FEM-PrEP participants reported on their reasons for taking the study pills through a quantitative, audio computer-assisted self-interview (ACASI). Thematic analysis and descriptive statistics were used to analyze the qualitative and quantitative data, respectively. RESULTS:Five themes were identified from the SSIs as facilitating factors of adherence: 1) participants' support for the research, 2) HIV risk reduction, 3) routine formation and use of tools, 4) adherence counseling, and 5) partner awareness and support. Participants described similar facilitators when they spoke about other participants' adherence. Among the 172 participants who reported in ACASI that they had taken a study pill, wanting to help answer the research question was the most frequently stated reason for taking the pills (94%, n = 161). We also found evidence of preventive misconception. CONCLUSIONS:Adherence was facilitated by personal motivations, such as risk reduction and interest in the research outcome, and by adherence strategies consisting of external cues, reminders, and support. These findings can inform future HIV ...
Keywords	Medicine ; R ; Science ; Q
Subject code	150
Language	English
Publishing date	2015-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The Role of Endophytic Fungi in the Anticancer Activity of Morinda citrifolia Linn. (Noni)

Yougen Wu / Sisay Girmay / Vitor Martins da Silva / Brian Perry / Xinwen Hu / Ghee T. Tan

Evidence-Based Complementary and Alternative Medicine, Vol

2015 Volume 2015

Abstract: We hypothesize that the fungal endophytes of noni may possibly play a role in its overall pharmacological repertoire, especially since the perceived efficacy of the fruit in ethnomedicinal use is associated with the fermented juice. The foremost goal of ... ...

Abstract	We hypothesize that the fungal endophytes of noni may possibly play a role in its overall pharmacological repertoire, especially since the perceived efficacy of the fruit in ethnomedicinal use is associated with the fermented juice. The foremost goal of this study is to explore the role of endophyte-derived secondary metabolites in the purported anticancer properties of noni. To that end, culturable endophytic fungi resident within the healthy leaves and fruit of the plant were isolated and identified by molecular sequence analysis of the 5.8S gene and internal transcribed spacers (ITS). Purified organisms were subjected to in vitro fermentation in malt extract broth for 8 weeks under anaerobic conditions at room temperature (25°C), in order to simulate the conditions under which traditional fermented noni juice is prepared. The cytotoxic potential of organic extracts derived from the fermented broths of individual endophytes was then tested against three major cancers that afflict humans. Twelve distinct endophytic fungal species were obtained from the leaves and 3 from the fruit. Three of the leaf endophytes inhibited the growth of human carcinoma cell lines LU-1 (lung), PC-3 (prostate), and MCF-7 (breast) with IC50 values of ≤10 μg/mL.
Keywords	Other systems of medicine ; RZ201-999
Subject code	630
Language	English
Publishing date	2015-01-01T00:00:00Z
Publisher	Hindawi Limited
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Indigenous bacteria enhance growth and modify essential oil content in Leptospermum scoparium (mÄnuka)

Wicaksono, Wisnu Adi / Elisabeth Eirian Jones / Catherine Elizabeth Sansom / Nigel Brian Perry / Jana Monk / Amanda Black / Hayley Jane Ridgway

New Zealand journal of botany. 2017 July 3, v. 55, no. 3

2017

Abstract: Leptospermum scoparium J.R.Forst. et G.Forst. var. scoparium (Myrtaceae), or mÄnuka, is a New Zealand medicinal plant that yields essential oils with varying triketones concentrations. The effects of mÄnuka-associated bacteria, isolated from plants ... ...

Abstract	Leptospermum scoparium J.R.Forst. et G.Forst. var. scoparium (Myrtaceae), or mÄnuka, is a New Zealand medicinal plant that yields essential oils with varying triketones concentrations. The effects of mÄnuka-associated bacteria, isolated from plants growing in five regions, on growth and essential oil composition of one regional variety, were investigated for the first time. Leaf essential oil compositions and yields were determined by microscale solvent extraction and GC-MS analyses. Erwinia sp. T4MS11P and Pseudomonas sp. M3R43 increased growth compared to control plants. Plants inoculated with Erwinia sp. T4MS11P had similar concentrations of triketone grandiflorone as control plants, whereas plants inoculated with Pseudomonas sp. M3R43 had lower grandiflorone concentrations. In contrast, inoculation with a bacterial consortium isolated from the West Coast did not increase plant growth, but gave higher grandiflorone concentrations (> 160%) compared to control plants. The different treatments showed some effects on qualitative oil composition, but these were not significantly different between regional chemotypes. Overall, the results demonstrated that bacteria increased the growth of mÄnuka and grandiflorone concentrations in leaves. These effects would be valuable in commercial essential oil production from plantation-grown mÄnuka.
Keywords	Erwinia ; Leptospermum scoparium ; Pseudomonas ; bacteria ; chemotypes ; coasts ; essential oils ; gas chromatography-mass spectrometry ; leaves ; lipid content ; medicinal plants ; oils ; plant growth ; solvents ; New Zealand
Language	English
Dates of publication	2017-0703
Size	p. 306-317.
Publishing place	Taylor & Francis
Document type	Article
ZDB-ID	2098798-5
ISSN	1175-8643 ; 0028-825X
ISSN (online)	1175-8643
ISSN	0028-825X
DOI	10.1080/0028825X.2017.1330272
Database	NAL-Catalogue (AGRICOLA)

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