scholarly journals Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Tilde Dombernowsky ◽  
Merete Haedersdal ◽  
Ulrik Lassen ◽  
Simon Francis Thomsen
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
Site Selection ◽  
Decision Makers ◽  
Relative Importance ◽  
Related Factors ◽  
Trial Site ◽  
Large Patient ◽  
Research Organizations

Abstract Background Knowledge of what the pharmaceutical industry emphasizes when assessing trial sites during site selection is sparse. A better understanding of this issue can improve the collaboration on clinical trials and increase knowledge of how to attract and retain industry-sponsored trials. Accordingly, we investigated which site-related qualities multinational biopharmaceutical companies and clinical research organizations (CROs) find most important during site selection. Methods An online survey among decision-makers for trial site selection in the Nordic countries employed at multinational biopharmaceutical companies and CROs was conducted. The respondents’ experiences with and perceptions of site selection were addressed to evaluate the relative importance of site-related qualities. We included up to four respondents per company, representing different geographic regions. Descriptive statistics were used to summarize findings. Results Of 49 eligible companies, 20 biopharmaceutical companies and 23 CROs participated. In total, 83 responses were analyzed (estimated response rate 78%). A relative importance of site-related qualities was identified: For example, 88% (binomial 95% confidence interval [CI] ±7%) preferred reaching enrollment goals at trial sites in their region 10% quicker rather than cutting the costs at all sites by 20%. Likewise, 42% (CI ±11%) of the respondents preferred that trial sites were best at having the first patients ready for inclusion right after site initiation visit compared to having good data entry, documentation, and reporting practice (25% [CI ±9%]), easily reachable site personnel and backup (23% [CI ±9%]), fast contractual procedure times (6% [CI ±5%]), a key opinion leader associated with the site (3% [CI ±4%]), and updated equipment and facilities (1% [CI ±2%]). In total, 75% [CI ±9%] agreed that their company would be interested in cooperating with an inexperienced trial site if the site had access to a large patient population and 52% [CI ±11%] had experienced that their company selected an inexperienced trial site in favor of an experienced site due to a higher level of interest and commitment. Conclusions This study indicates that recruitment-related factors are pivotal to the pharmaceutical industry when assessing trial sites during site selection. Data quality-related factors seem highly valued especially in early phase trials whereas costs and investigator’s publication track record are less important. Experience in conducting clinical trials is not imperative. However, this applies primarily to late phase trials.

Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement

2021 ◽  
pp. OP.20.00821
Author(s):  
Dax Kurbegov ◽  
Patricia Hurley ◽  
David M. Waterhouse ◽  
Nicholas J. Robert ◽  
Grzegorz S. Nowakowski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Task Force ◽  
Trial Site ◽  
Novel Treatments ◽  
Research Organizations ◽  
Start Up ◽  
Clinical Trial Site ◽  
Oncology Clinical Trials ◽  
Timely Access ◽  
More Trial

PURPOSE: Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments. METHODS: An ASCO Task Force was convened to assess the specific burdens and challenges with FAs and to develop recommendations to improve their efficiencies and effectiveness. Stakeholders (including trial sites, biotech-pharma sponsors, and CROs) provided insights into challenges and offered solutions through two surveys and an in-person meeting. The Task Force used the feedback to formulate consensus recommendations to improve FAs for oncology clinical trials. RESULTS: Three key recommendations were identified for application across all biotech-pharma sponsored trials: (1) implement a streamlined and uniform FA process across trials and sponsors; (2) minimize and standardize questions; and (3) leverage technology to centralize FAs, facilitate communications, and reduce redundancies. CONCLUSION: There is an urgency to improve the current FA process, which is costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness. All stakeholders stand to benefit from implementing these recommendations, which aim to minimize burdens and ensure that more trial sites and patients have timely access to oncology clinical trials. To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.

scholarly journals Magyar klinikai vizsgálatok sajátosságai egy nemzetközi adatbázis elemzése alapján

2017 ◽  
Vol 158 (9) ◽  
pp. 345-351
Author(s):  
Tamás Tóth ◽  
Péter Pollner ◽  
Gergely Palla ◽  
Elek Dinya
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Data Cleaning ◽  
Free Text ◽  
Research Organizations ◽  
The Us ◽  
Us Government ◽  
International View ◽  
Significant Data

Abstract: Intorduction: The ClinicalTrials.gov website, which is operated by the US government, collects data about clinical trials. Aim: We have processed data related to Hungary by downloading from the website as XML files. Method: Most of the data describe trials performed after 2000, so we got an overview about the clinical research of the last 10 to 15 years. As the majority of the data fields are collected as free text, significant data cleaning was needed. Results: The database contained 2863 trials related to Hungary from 189 settlements. Only 20 per cent of the actual research organizations could have been identified as many times only an “id” number or a general name was given, thus this information was anonymised in many cases. Conclusion: Besides the analysis of the information obtained from this database, our study points out the relevant issues that may influence the international view of the Hungarian clinical research. Orv. Hetil., 2017, 158(9), 345–351.

Current Issues Surrounding Women and Minorities in Drug Trials

1993 ◽  
Vol 27 (7-8) ◽  
pp. 904-911 ◽  
Author(s):  
Daniel P. Wermeling ◽  
Ada Sue Selwitz
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
New Drugs ◽  
Ethical Principles ◽  
Investigational Drug ◽  
Federal Regulations ◽  
Drug Trials ◽  
New Drug ◽  
Research Risks

OBJECTIVE: Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last decade certain segments of society, particularly women and minorities, have demanded greater participation in clinical drug trials and earlier access to investigational drug therapies. Regulations that have served the clinical research community (pharmaceutical industry, investigators, institutional review boards) as guidelines for safe conduct of human clinical trials are being challenged by social and political change. This article provides an overview of some of the controversy relative to federal regulations governing clinical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research. DATA SOURCES: Literature for this paper was retrieved from a variety of sources including the nonmedical press, editorials, peer-reviewed journals, Department of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration. DATA SYNTHESIS: Scientists evaluating new therapeutic agents ask specific research questions to assess safety, efficacy, and the mechanism(s) of action. Because of concerns for scientific validity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ultimate users of a new drug. Federal regulations and ethical principles allow certain groups of people to be excluded from early research proposals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, and other populations are demanding greater access to investigational drugs. The focus has changed from protection from research risks and burdens to the potential benefits a person or class of people may obtain by participating in a study. CONCLUSIONS: Scientists, the pharmaceutical industry, regulators, and society must agree on a safe and efficient mechanism for new drug development that permits more equitable participation of subjects in the various phases of research.

Oncology clinical research landscape in Middle East and North Africa (MENA) region: Challenges and proposed solutions.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13567-e13567
Author(s):  
Kareem Sameh ◽  
Natasha Khalife
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Middle East ◽  
Clinical Research ◽  
North Africa ◽  
Research Infrastructure ◽  
Trial Participation ◽  
Mena Region ◽  
Large Patient ◽  
Oncology Clinical Trials

e13567 Background: Similar to other regions of the world, cancer incidence in Middle East and North Africa (MENA) is rising, which has been attributed to increased life expectancy and adoption of western lifestyle habits. Conducting clinical trials in the region is important to assess efficacy and safety of oncology medications in the specific population (response to drugs can be impacted by genetics, demographics and lifestyle factors). Although the MENA comprises around 5% of the global population, the region only participates in approximately 3% of clinical trials worldwide. It is important to understand the challenges in conducting trials in MENA and identify strategies to overcome these in order to facilitate advances in clinical research in the region. Methods: A literature review was conducted (via e.g. PubMed and ClinicalTrials.gov) to understand the current oncology clinical research landscape in MENA (from Jan 2015-Dec 2020), with the aim of identifying key challenges and potential strategies to overcome these. Results: Conduct of oncology clinical trials (phases 1-4) has risen in recent years in MENA, from 47 trials in 2015 to 53 trials in 2020. Despite the presence of various research-favourable factors in MENA (large patient pool, high demand for medication, lower clinical trial operational costs, compliance with ICH-GCP standards), the region still falls behind other countries in clinical research. Key factors identified as challenges in conducting clinical trials in MENA include the research infrastructure and patient awareness/understanding of research. We propose the following strategies to support the advancement of clinical research in the region: (1) Enhance research infrastructure through bolstering national clinical research networks and supporting collaboration between healthcare institutes, academia and the pharma industry; (2) Diversify methods of patient engagement (e.g. patient advisory groups and social media networks) and provide education on pros/cons of participating in research to raise awareness and improve trial participation rates; and (3) Improve availability of comprehensive oncology registries to enhance understanding of disease burden and support clinical research. Conclusions: The conduct of oncology clinical trials in MENA is increasing, yet the region is still under-represented in the global clinical trial market, despite its significant potential. The advancement of clinical research in the region will require a multi-level approach, involving collaboration between multiple stakeholders including the pharma industry, regulators, government, and healthcare professionals.

scholarly journals What is the impact of patient recruitment on offshoring of clinical trials?

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Maryam Kermanimojarad
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
Policy Decision ◽  
The United States ◽  
Decision Makers ◽  
Related Factors ◽  
Main Driver ◽  
Key Driver ◽  
The Impact ◽  
Insight Into

Abstract The issue of globalization of research is receiving considerable attention due to the increasing number of offshored R&D activities from the United States, Europe, and Japan. This paper explores this phenomenon and provides a model to analyze the factors that will likely contribute to a global transformation of clinical trials. By identifying the main characteristics of clinical trials, I aim to clarify the main driver of the relocation process of clinical research. I reviewed the relevant published articles to address the research questions. The results of this study challenge the traditional thinking of cost-related factors as the major reason for offshoring cilinical trials and show the importance of the recruitment of human subjects in trials. Consequently, this paper suggests that “recruitment crisis” in home country as the main contribution and a key driver to offshore R&D activities, has been underestimated by previous studies. In particular, this study provides policy-decision makers with a new insight into the development issue surrounding the pharmaceutical industry.

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