scholarly journals Future of risk based monitoring in clinical trials

2020 ◽  
Vol 7 (3) ◽  
pp. 221
Author(s):  
Niraj R. Vyas
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Treatment Options ◽  
Machine Learning Algorithms ◽  
Mitigation Strategies ◽  
Eligibility Criteria ◽  
New Ways Of Working ◽  
Trial Conduct ◽  
The Future ◽  
The Impact

<p class="abstract">Drug development is a complex and resource intensive endeavor. The average cost of developing a new drug, has been estimated to be $2 to $3 billion. However, the success rate of clinical trials is very low around and is estimated to be between 3-5%. The common reasons for failure of clinical trials include failure to demonstrate efficacy or safety, budgeting and financing, failure of subjects meeting protocol eligibility criteria, poor investigator site selection, patient withdrawals and dropouts. Considering the growing demands to get better and affordable treatment options, there needs to be fundamental shift required in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonisation in the E6 R2 addendumhas now provided guidelines for adaptation of risk based approach to trial conduct and monitoring to implement mitigation strategies for potential risks which might derail the conduct of the trail. The industry is steadily gearing up to put together the required processes, systems and teams to align to the new ways of working. However with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, esource, electronic health record/electronic medical records interoperability, implementation of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now. This paper explores the impact of these new developments on the future of risk based monitoring in clinical trials.</p>

scholarly journals Co-Clinical Trials: An Innovative Drug Development Platform for Cholangiocarcinoma

2021 ◽  
Vol 14 (1) ◽  
pp. 51
Author(s):  
Brinda Balasubramanian ◽  
Simran Venkatraman ◽  
Kyaw Zwar Myint ◽  
Tavan Janvilisri ◽  
Kanokpan Wongprasert ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Drug Development ◽  
Surgical Resection ◽  
Treatment Options ◽  
Standard Of Care ◽  
Time Data ◽  
Current Standard ◽  
Innovative Drug ◽  
Curative Intent

Cholangiocarcinoma (CCA), a group of malignancies that originate from the biliary tract, is associated with a high mortality rate and a concerning increase in worldwide incidence. In Thailand, where the incidence of CCA is the highest, the socioeconomic burden is severe. Yet, treatment options are limited, with surgical resection being the only form of treatment with curative intent. The current standard-of-care remains adjuvant and palliative chemotherapy which is ineffective in most patients. The overall survival rate is dismal, even after surgical resection and the tumor heterogeneity further complicates treatment. Together, this makes CCA a significant burden in Southeast Asia. For effective management of CCA, treatment must be tailored to each patient, individually, for which an assortment of targeted therapies must be available. Despite the increasing numbers of clinical studies in CCA, targeted therapy drugs rarely get approved for clinical use. In this review, we discuss the shortcomings of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy drugs. The increased availability of targeted therapy drugs for treatment is expected to facilitate the application of precision medicine in CCA.

Building capacity and ensuring equity in clinical trials during the COVID-19 pandemic.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13598-e13598
Author(s):  
Helen Winter ◽  
Joanna Willis ◽  
Stephen Lang ◽  
Kay Drury ◽  
Jonathan Heywood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practice ◽  
Treatment Interruptions ◽  
Clinical Ward ◽  
The Everyday ◽  
The Future ◽  
Ward Rounds ◽  
Equity Of Access ◽  
The Impact

e13598 Background: The impact on cancer outcomes from the Covid-19 pandemic has yet to be determined. Concerns persist on screening, delays in diagnosis, treatment interruptions and outcomes of infection in the immunosuppressed. The need for agile working has been exemplified by establishment of Nightingale Hospitals, staff redeployment and sudden integration of virtual consultations into clinical working. With most cancer clinical trials halted, recruitment into COVID-19 research became essential and embedded into the everyday. Here we present how rapid implementation of COVID-19 randomised clinical trials within an NHS organisation during the pandemic was achieved. Methods: A COVID-19 senior facilitation committee was set up to provide oversight, maximise staff capacity and resource and prioritise studies. Specific strategies to maximise access and clinical trials recruitment for patients including children and those with solid tumours were designed. These included presence of a research nurse at clinical ward rounds and team meetings, the promotion of protocol and informed consent training to all including doctors in the acute settings and weekly research meetings to share-best practice. Reflecting on learnings from this time provide an opportunity to consider how we adjust working for our patients in the future. Results: The integration of research into the everyday working of clinical teams looking after patients with COVID-19 has become the norm. The provision of protocol and informed consent training for all levels of staff and the consideration of all patients for trials during clinical ward rounds and multi-disciplinary meetings, have ensured access to trials has become embedded. The integration of research nurses working, upskilling and prompting clinical colleagues has ensured equity of access and provided a research presence and focus during the busy clinical day. The adoption of cross-disciplinary working, sharing best practice and a culture of commitment and support to the trials ensures no patient is denied the opportunity to participate. Three RTCs opened over 7 weeks. At one site 1904 patients were screened for one of the randomised-controlled trials and over 18% of these patients (351) were recruited and 175 patients declined. Conclusions: The pandemic has had a devastating impact across the UK. However, a coordinated and collaborative multi-disciplinary approach has supported high recruitment and equity of access for patients into COVID-19 trials. Learnings from this work may lead to embedding clinical trials and access to translational research for cancer patients in the future as we recover from the full impact of the pandemic. COVID-19 research has demonstrated how increased recruitment accelerates access and implementation of new innovations and novel drug combinations.The full impact of improved access to cancer research in the future during COVID recovery is worthy of more research.

Contraception Options in Neurologic Disease

2018 ◽  
Author(s):  
Tessa L. Reisinger ◽  
Amy Robinson Harrington
Keyword(s):  
Chronic Disease ◽  
Contraceptive Use ◽  
Unplanned Pregnancy ◽  
Treatment Options ◽  
Hormonal Contraception ◽  
Neurologic Disease ◽  
Eligibility Criteria ◽  
Increased Risk ◽  
Wide Range ◽  
The Impact

Unplanned pregnancy has particular implications for women with chronic disease, including increased risk of adverse health events during pregnancy and potential impact on disease course or treatment options. While preventing unplanned pregnancy is especially important in this population, both medications and sequelae of chronic disease must be considered in choosing safe and effective contraceptive options. The US Medical Eligibility Criteria for Contraceptive Use were established to provide guidance on contraceptive use for women with various disease conditions; however, specific guidelines for many neurologic conditions are limited. This chapter reviews evidence and recommendations for contraception options in women with a wide range of neurologic conditions. Considerations include interactions with medications, the risk of venous thromboembolism in the setting of reduced mobility, and the impact of hormonal contraception on symptom frequency and disease progression. In many cases, long-acting reversible contraception (LARC) methods offer highly effective, well-tolerated contraception for women with neurologic disease.

Integrating clinical pharmacy services into patient care in an early-phase clinical trial clinic.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18228-e18228
Author(s):  
Dazhi Liu ◽  
Thu Oanh Dang ◽  
Stephen Harnicar ◽  
Katherine Kargus ◽  
Lauren A Evans ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Clinical Pharmacist ◽  
Early Phase ◽  
Treatment Options ◽  
Cancer Center ◽  
Protocol Violation ◽  
Patients With Cancer ◽  
The Impact

e18228 Background: Early phase clinical trials have broadened treatment options for patients with cancer. Expert management of these new therapies is essential to positive patient outcomes. At Memorial Sloan Kettering Cancer Center, the Developmental Therapeutic Center (DTC) satisfies this need. Oncology clinical pharmacists collaborate with other healthcare professionals to maximize the benefits of drug therapy and minimize toxicities. The purpose of this project is to describe the interventions from a clinical pharmacist assigned to the DTC. Methods: A clinical pharmacist joined DTC to serve adult patients with cancer undergoing clinical trials. The clinical pharmacist acted as a liaison between pharmacy team and medical team, and sees patients during their trial eligibility screening and follow-up visits. The interventions were documented by the clinical pharmacist in patients’ medical charts and email communications. All interventions during 1 month were retrospectively collected and categorized into supportive care optimization, protocol violation prevention, and operational. Results: The oncology clinical pharmacist was involved in 115 patient visits for trial eligibility screening or protocol follow-up. A total of 769 interventions were addressed including supportive care optimization (40.2%), protocol violation prevention (24.7%), and operational (35.1%). Conclusions: The oncology clinical pharmacist is actively engaged in many aspects of cancer care at the early phase trial clinic. Our results demonstrate the vital role of an oncology clinical pharmacist. The impact of these categorized intervention areas would require a formal outcome and cost-saving analysis. [Table: see text]

scholarly journals Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry

2021 ◽  
pp. 495-505
Author(s):  
Rana R. McKay ◽  
Theresa Gold ◽  
Jelani C. Zarif ◽  
Ilkania M. Chowdhury-Paulino ◽  
Adam Friedant ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Race And Ethnicity ◽  
Working Group ◽  
Advanced Prostate Cancer ◽  
Unmet Need ◽  
Minority Populations ◽  
Eligibility Criteria ◽  
Patient Reported ◽  
The Impact

Prostate cancer disproportionately affects racial and ethnic minority populations. Reasons for disparate outcomes among minority patients are multifaceted and complex, involving factors at the patient, provider, and system levels. Although advancements in our understanding of disease biology have led to novel therapeutics for men with advanced prostate cancer, including the introduction of biomarker-driven therapeutics, pivotal translational studies and clinical trials are underrepresented by minority populations. Despite attempts to bridge the disparities gap, there remains an unmet need to expand minority engagement and participation in clinical trials to better define the impact of therapy on efficacy outcomes, quality of life, and role of biomarkers in diverse patient populations. The IRONMAN registry (ClinicalTrials.gov identifier: NCT03151629 ), a global, prospective, population-based study, was borne from this unmet medical need to address persistent gaps in our knowledge of advanced prostate cancer. Through integrated collection of clinical outcomes, patient-reported outcomes, epidemiologic data, and biospecimens, IRONMAN has the goal of expanding our understanding of how and why prostate cancer outcomes differ by race and ethnicity. To this end, the Diversity Working Group of the IRONMAN registry has developed informed strategies for site selection, recruitment, engagement and retention, and trial design and eligibility criteria to ensure broad inclusion and needs awareness of minority participants. In concert with systematic strategies to tackle the complex levels of disparate care, our ultimate goal is to expand minority engagement in clinical research and bridge the disparities gap in prostate cancer care.

scholarly journals AI4CoV: Matching COVID-19 Patients to Treatment Options Using Artificial Intelligence

2020 ◽  
Author(s):  
Andrew I. Hsu ◽  
Amber S. Yeh ◽  
Shao-Lang Chen ◽  
Jerry J. Yeh ◽  
DongQing Lv ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Language Processing ◽  
Cross Validation ◽  
Early Stage ◽  
Treatment Options ◽  
Clinical Manifestations ◽  
Ground Truth ◽  
English Text ◽  
Eligibility Criteria ◽  
Clinical Notes

AbstractWe developed AI4CoV, a novel AI system to match thousands of COVID-19 clinical trials to patients based on each patient’s eligibility to clinical trials in order to help physicians select treatment options for patients. AI4CoV leveraged Natural Language Processing (NLP) and Machine Learning to parse through eligibility criteria of trials and patients’ clinical manifestations in their clinical notes, both presented in English text, to accomplish 92.76% AUROC on a cross-validation test with 3,156 patient-trial pairs labeled with ground truth of suitability. Our retrospective multiple-site review shows that according to AI4CoV, severe patients of COVID-19 generally have less treatment options suitable for them than mild and moderate patients and that suitable and unsuitable treatment options are different for each patient. Our results show that the general approach of AI4CoV is useful during the early stage of a pandemic when the best treatments are still unknown.

scholarly journals Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients

2020 ◽  
Author(s):  
Eudocia Q Lee ◽  
Michael Weller ◽  
Joohee Sul ◽  
Stephen J Bagley ◽  
Solmaz Sahebjam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Response Assessment ◽  
Primary Brain Tumor ◽  
Trial Participation ◽  
Cooperative Groups ◽  
Clinical Trial Participation ◽  
Eligibility Criteria ◽  
Trial Conduct ◽  
The Impact ◽  
Clinical Trial Conduct

Abstract Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology, the Response Assessment in Neuro-Oncology Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive and unnecessary and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as a barrier to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

scholarly journals It is unprecedented: trial management during the COVID-19 pandemic and beyond

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Eleanor J. Mitchell ◽  
Khaled Ahmed ◽  
Suzanne Breeman ◽  
Seonaidh Cotton ◽  
Lynda Constable ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Collection ◽  
Trial Management ◽  
National Network ◽  
Intervention Delivery ◽  
New Ways Of Working ◽  
The Future ◽  
Working Together ◽  
The Uk

Abstract The COVID-19 pandemic has presented unique challenges for the clinical trial community, both in the rapid establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused (whether that is a complete pause or pause in some activities) and/or adapting their processes. Trial managers have played a key role in decision-making, undertaking risk assessments and adapting trial processes, working closely with other members of the research team. This article presents some of the ways in which trial management processes have been altered and the key role that trial managers have played. It has been born out of discussions between trial managers in the UK who are members of the UK Trial Managers’ Network (UKTMN), a national network of trial management professionals managing non-commercial trials. In these unprecedented times, clinical trials have faced many uncertainties and broad-ranging challenges encompassing a range of activities including prioritising patient safety amidst the pandemic, consenting and recruiting new participants into trials, data collection and management and intervention delivery. In many cases, recruitment has been paused whilst mitigations have been put in place to continue data collection. Innovative solutions have been implemented to ensure we continue, where possible, to deliver high-quality clinical trials. Technology has provided many solutions to these challenges, and trial managers have adapted to new ways of working whilst continuing to deliver their clinical trials. Trial management groups are now faced with new uncertainties around re-starting clinical trials, and it is unclear currently how this will go, though working together with sponsors, funders and site teams is clearly a priority. Clinical trial teams have worked together to ensure their trials have adapted quickly whilst ensuring participant safety is given utmost importance. There are clear examples where the trial community have come together to share experiences and expertise, and this should continue in the future to ensure the innovative practices developed become embedded in the design and conduct of clinical trials in the future.

The impact of the COVID-19 pandemic on oncology clinical trial recruitment in an Irish cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18756-e18756
Author(s):  
Ronan Andrew McLaughlin ◽  
Valerie Madigan ◽  
Maureen O'Grady ◽  
Thamir Andrew Mahgoub ◽  
Roshni Andrew Kalachand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Treatment Options ◽  
Cancer Clinical Trial ◽  
University Hospital ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Number Of Patients ◽  
The Impact

e18756 Background: The COVID-19 pandemic has created unprecedented disruptions to cancer clinical trial research across the world due to a temporary global suspension of patients’ recruitment to cancer clinical trials. Access to clinical trials permits better treatment options and best clinical practice standards for patients with cancer. We present the impact of the COVID-19 pandemic on cancer clinical trial activity at the Cancer Clinical Trials Unit (CCTU) at the Mid-Western Cancer Centre, University Hospital Limerick (UHL). Over the last 4 years 28 clinical trials, both interventional and translational, have opened here, across a variety of primary disease sites, with 5 trials opened in 2017, 11 in 2018, 7 in 2019 but only 2 in the first 10 months of 2020 until 3 further trials were opened in December. Methods: CCTU records were reviewed to identify the number of patients screened and consented to participate in cancer clinical trials at UHL in 2020, which were compared directly with corresponding numbers for 2019. Results: In 2019, 17 clinical trials were open and recruiting at the CCTU, UHL. During 2020, 19 trials were recruiting although during the 1st surge of the COVID-19 pandemic recruitment was essentially suspended and CCTU staff were redeployed throughout the hospital. 1st Six months 2020 vs 2019 In the six months from January 2020 until the end of June 2020, 99 patients were screened and only 15 (15.2%) signed informed consent to participate in a cancer clinical trial. When these figures are directly compared with the first six months of 2019, there is a 33% reduction in patients screened for participation (147 vs 99) and a 60% reduction in patients consented (37 vs 15) to clinical trials. 12 Months 2020 vs 2019 In total during 2019, 376 patients were screened for inclusion to participate and 49 (13%) patients signed informed consent to participate in a clinical trial within CCTU at UHL. In 2020, 914 patients were screened for participation with 51 patients consented to participate (5.6%). The majority (45/51 (88%)) of patients consented to cancer clinical trials in 2020 at the CCTU, UHL were recruited to translational based studies and only 6 (12%) consented to interventional studies compared with 2019 when 30/49 (61%) consented to translational and 30/49 (39%) to interventional studies. Conclusions: During the COVID-19 pandemic, the percentage of patients consented to participation in a clinical trial reduced significantly, as compared to the previous year (5.6% vs 13%). Fewer interventional studies have recruited patients during 2020. As we enter the third surge of COVID-19 infections in Ireland, we must continue to monitor and identify effective strategies to navigate the ever-changing situation for cancer clinical trials, in an attempt to maintain access to high quality cancer clinical trial opportunities for our patients.

20. The Future in a Post-COVID World

2021 ◽  
pp. 689-716
Author(s):  
Alisdair A. Gillespie ◽  
Siobhan Weare
Keyword(s):  
Criminal Justice ◽  
Legal System ◽  
New Normal ◽  
New Ways Of Working ◽  
Parliamentary Debate ◽  
Criminal Justice Systems ◽  
The Future ◽  
Justice Systems ◽  
The Government ◽  
The Impact

This chapter considers the impact that COVID-19 has had on the English Legal System. The chapter is broken down into sections that mirror the parts of this book. The chapter begins by noting that the manner in which laws are passed differed because of coronavirus. The government were given wide-ranging powers to introduce new laws that restricted liberty. In many instances, these were not subject to Parliamentary debate or judicial analysis. The chapter also considers how the courts had to adjust to new ways of working. While traditionally, the courts rely on live proceedings, with everyone gathered in court, this was not possible throughout the pandemic. Remote hearings became the new normal until so-called ‘Nightingale Courts’ were introduced to allow for socially-distant trials to resume. However, this has led to significant delays in both the civil and criminal justice systems that will have a lasting impact. The chapter considers not only what has happened during the coronavirus pandemic, but also what lessons have been learnt that can carry through to the future.

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