AUCTORES
Globalize your Research
Chat with us
Research article | DOI: https://doi.org/10.31579/2693-4779/108
Independent researcher in clinical trials, CIS (Russsia, Georgia, Belorussia).
*Corresponding Author: Svyatoslav Milovanov. independent researcher in clinical trials, CIS (Russsia, Georgia, Belorussia).
Citation: Svyatoslav Milovanov. (2022) Principal Investigators and Site in the Challenges of Clinical Trials - Recruitment and Contemporary Tendencies. Clinical Research and Clinical Trials. 6(3); DOI: 10.31579/2693-4779/108
Copyright: © 2022 Svyatoslav Milovanov, This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received: 18 August 2022 | Accepted: 07 September 2022 | Published: 25 September 2022
Keywords: zinner syndrome; seminal vesicle carcinoma
Annotation:
Clinical trial is cutting edge of science to bring the so needed medicines to the suffering patients over the whole world. Cutting edge always the challenge and modern challenges now substantially increased and consist of digitalisation, decentralization, personalization and many others new tendencies and the meantime the old challenges like recruitment of patients keeps saved. From the one side challenges is facilitating the trial but from others it requires much more education, trainings and a time. It could seem that role of investigators and site can be reduced by these tendencies and to reveal it we will highlite the tendencies by the perspectives of site and site. The role of principal investigator anyway still continues to be the important for all of this challenges.
Materials and Methods: Review of the publicaitons randomly found on the topic of challenges and Principal investigators and site in the challenges of clinical trials - recruitment and contemporary tendencies.
Study objectives: to highlight Principal investigators and site in the challenges of clinical trials - recruitment and contemporary tendencies
Statistical analysis: there were no statistics and only the observation of journal open sources.
Results: It was reviewed the modern and old tendencies in clinical trials Principal investigators and site in the challenges of clinical trials - recruitment and contemporary tendencies.
Discussion: Recruitment as an old challenge to continue to be important part of clinical trials and this challenges and role of site and principal investigators continue to be important. Modern tendencies as new challenges require the site and principal investigator even be a more involvoing to the clinical trial compare to conventional centralyzed trials.
Clinical trials as of today is the way to provide the society with the effective and safe treatment and diagnostic approaches to the patients (Friedman, L, 2010, Toerien M. Et al., 2009).
Over 34000 clinical trials are conducting annually in the world. Data of clinicaltrial.gov for 2021 year consist of 34,528 studies including all phases.
The number of patients who is participating in clinical trials annually is dozens of millions. But anyway, this not more than 2-5% out of patients could be participating (Mona N. Fouad at all, 2013)
Cost to reach the approval is so high that it could seems that the more cost done the more success is expecting. For example, now to reach the succes in clinical trial it could be spent more than 10+ years and more than 2+ bln USD, but only 1% bring the approaches to the patient or reach the market or, by other words, having overcome all approvals and studies to be safe and effective in order to give favor to the patients (Woodin K. at al., 2003).
The reasons of this result are due to challenges rasing during the development of the Investigational Medicinal Product.
It was done the review of the randomly found publications the topic of challenges and Principal investigators and site in the challenges of clinical trials - recruitment and contemporary tendencies. It was grouped found challenges and tendencies in a few gropus and discussed it.
Statistical Analysis:
No statistical analysys done.
Clinical trials traditionally are conducting in hospitals or medical centers and being called CENTRALYZED or conventional trials and this is set up in ICH GCP any revisions (ICH GCP).
Based on the literature (Herzhoff Y., 2022, Bonner K., 2022) we grouped following challenges:
Challenges:
1. Related with the study itself (protocol, site, recruitment)
2. non-related with site – pandemic, politicial reasons.
Challenges related with the study could be shown like below:
1. To proof that the new approach effective and safe.
EfficacySafety and efficasy is the first aims of any clinical trial and this is indeed the challenge to proof that the new IMP more effective and safer than the previous IMP.
2. To finance the study Fundraising the study.
Definitely when study started sometime company who run the study could not find the resources to finish the study.
3. To involve and keep patients in study.
Recruitment of the patients. Retention of the patients.
Recruitment and retention are pertaining to the patients and boths is the big challenge
4. To be always motivated to perform a study.
Motivation to do the study is one of the key drivers inside the site’s team, follow the P.G de Jong (2015) and O. Rengering (2014) the approach when the more dedicated and motivated investigator locally the more recruitment rate will appear. Motivations has to have a leader and it must be a principal investigator.
5. Others challenges related with the study:
Many others (regulatory, eligibility criteria, education of staff, diversity)
The most important challenge is the recruitment of patients and retention them in study. The studies which are failed in recruitment of patients is reaching up to 80% (Kelsey M. 2011). Additionally, 85% trial fail to retain a patients and drop-out rate reached up to 15-30% (Brooks’ S. Et al., 2015)
CHALLENGES NON-RELATED with study
The challenges in clinical trials partly calls a tendency of clinical trials. Of course, the tendencies are the evolution of clinical trials.
Not all the tendencies have a clear determination and description (Lazarus A, 2004, DeSantis, S, 2005, Munroe J., 2004, Ruano G., 2004, FDA, 2006,).
The tendecies now is:
All clinical trials are conducting by the principal investigators and his team even that for the 2021-year number of decentralyzed clinical trials is increased the “decentralyzed” does not mean excluding the site or clinical site from the particiation. Ed Miseta By Ed Miseta, (2021) Chief Editor, Clinical Leader is saying that centralyzed studies is dead. Centralyzed is alredy can be titled as traditional. Decentralised study is study which are conducting fully or partly out of clinical site.
When conducting the decentralyzed studies there is a necessity to conduct the protocol procedures out clinical site – in place of the patients and this cause a regulatory (like form 1572 for out of site nurse), ethical and some other considerations, but the recruitment and retetnion is vedry high compare with conventional studies (Adams, S. Et al., 2015
Patient-centric trials are defined as investigations that prioritize the needs of the patient at all stages, including design, activation, enrollment, data collection, completion and outcome reporting - (Bob T. Li B. et al, 2022) or by other words - Patient-centric studies is the study where the patient is determining the design of protocol in order to make it more comfortable to them
Virtualized studies
Risk-management approach in conducting of clinical trial
The evolution of precise tehcnology to nanotechnology is resulted to implementation of aritifical intellect (AI). AI as of now can track the very small and hardly revealed items related with safety for example. AI also a challenge (Bonner K, 2022
RWD/RWE approaches. Real world data and evidences now is more and more emerging tendencies and allow the patient and the investigator doing their job and simultaneolsy particpating in the study and nurse in these studies also doing their job in ordinary manner.
Hybridization of the studies
This is the mixture of any descibed above tendencise in the studies.
Rapid changes in the outlines of the present and future future primarily concern global medicine and trends are associated with a shift in focus from illness to general health, patient-centricity, digitalization of medicine (Herzhoff Y., 2022) including artificial intelligence (Bonner K., 2022) and the global strategy until 2030 includes the following goals for improving health - to guarantee universal access, continuity, coverage and quality of care through adequate investments to strengthen health systems and implement effective policies at the national, regional and global levels.
Since the start of clinical research, the first mention of which dates back to the 18th century (Bull J, 1959, Lilienfeld A., 1982), clinical studies were conducted for a long time in the composition - a sponsor, a researcher, which was then joined by an ethical component, and until the end of the 20th century, the scheme included a clinical center where patients were concentrated and basic procedures were carried out.
Currently, the classical scheme has certain modifications associated with the introduction of new technologies and we can talk about the following types of clinical trials (Lazarus A, 2004, DeSantis, S, 2005, Munroe J., 2004, Ruano G., 2004, FDA, 2006, Hekmat R et al., 2021, Wilkinson M., 2018, Blake A. 2022, Li B. Et al.)
Also, from the trends in CI, a shift in localization from Western countries to Eastern countries is clearly visible. Miseta E. (2021) cites data that in 2016, 23.6% of all clinical trials were initiated in the USA, and 12.5% in China. In 2018, the ratio was already 21.6% in both countries, and in 2019, the number of initiated clinical trials in China was already 23.7%, while in the US it fell to 20%. In the countries of India, Iran, Japan, Germany, and the UK, the number of new trials increased from 4.4% in 2016 to 10.9% in 2019. The growth of CT in the East is affected by the cost per patient - the cost of a phase 3 study in immuno-oncology in The US is 60 thousand dollars, in China - 25,000.
The trend of the aging of the population as a whole is obvious and, for example, according to estimates in China alone, the number of visits per year of the aging population is 2.2 billion dollars and 50 million visits.
We must also take into account the current epidemiological (Ledford H., 2021, Unger J., et al., 2021, WHO report 2022, NIH report, 2021) and political situations (Dalio R., 2022, Alsumudaie M, 2022, Castaneda C. 2022)
Patient-centricity trends are typical not only for clinical trials, but also for preclinical trials (Taylor N., 2022). However, the patient-centricity of CI has also been criticized (Mermet-Bouvier, P., 2020).
The future lies in blending gaming technology with clinical research (Sinha A., 2022)
Global standardization of CI is also a trend (Koski G. Et al., 2018)
Nevertheless, despite the trends in the virtualization of clinical trials, enrollment of patients remains the prerogative of centralized trials (Miseta E., 2021).
At the end we did not find that role of investigators and site’s team changed dramatically and reuires revised of the ICH GCP regulations which measn that principal investigator and hi team is still very important in the challenges of clinical trials - recruitment and contemporary tendencies.
Clearly Auctoresonline and particularly Psychology and Mental Health Care Journal is dedicated to improving health care services for individuals and populations. The editorial boards' ability to efficiently recognize and share the global importance of health literacy with a variety of stakeholders. Auctoresonline publishing platform can be used to facilitate of optimal client-based services and should be added to health care professionals' repertoire of evidence-based health care resources.
Journal of Clinical Cardiology and Cardiovascular Intervention The submission and review process was adequate. However I think that the publication total value should have been enlightened in early fases. Thank you for all.
Journal of Women Health Care and Issues By the present mail, I want to say thank to you and tour colleagues for facilitating my published article. Specially thank you for the peer review process, support from the editorial office. I appreciate positively the quality of your journal.
Journal of Clinical Research and Reports I would be very delighted to submit my testimonial regarding the reviewer board and the editorial office. The reviewer board were accurate and helpful regarding any modifications for my manuscript. And the editorial office were very helpful and supportive in contacting and monitoring with any update and offering help. It was my pleasure to contribute with your promising Journal and I am looking forward for more collaboration.
We would like to thank the Journal of Thoracic Disease and Cardiothoracic Surgery because of the services they provided us for our articles. The peer-review process was done in a very excellent time manner, and the opinions of the reviewers helped us to improve our manuscript further. The editorial office had an outstanding correspondence with us and guided us in many ways. During a hard time of the pandemic that is affecting every one of us tremendously, the editorial office helped us make everything easier for publishing scientific work. Hope for a more scientific relationship with your Journal.
The peer-review process which consisted high quality queries on the paper. I did answer six reviewers’ questions and comments before the paper was accepted. The support from the editorial office is excellent.
Journal of Neuroscience and Neurological Surgery. I had the experience of publishing a research article recently. The whole process was simple from submission to publication. The reviewers made specific and valuable recommendations and corrections that improved the quality of my publication. I strongly recommend this Journal.
Dr. Katarzyna Byczkowska My testimonial covering: "The peer review process is quick and effective. The support from the editorial office is very professional and friendly. Quality of the Clinical Cardiology and Cardiovascular Interventions is scientific and publishes ground-breaking research on cardiology that is useful for other professionals in the field.
Thank you most sincerely, with regard to the support you have given in relation to the reviewing process and the processing of my article entitled "Large Cell Neuroendocrine Carcinoma of The Prostate Gland: A Review and Update" for publication in your esteemed Journal, Journal of Cancer Research and Cellular Therapeutics". The editorial team has been very supportive.
Testimony of Journal of Clinical Otorhinolaryngology: work with your Reviews has been a educational and constructive experience. The editorial office were very helpful and supportive. It was a pleasure to contribute to your Journal.
Dr. Bernard Terkimbi Utoo, I am happy to publish my scientific work in Journal of Women Health Care and Issues (JWHCI). The manuscript submission was seamless and peer review process was top notch. I was amazed that 4 reviewers worked on the manuscript which made it a highly technical, standard and excellent quality paper. I appreciate the format and consideration for the APC as well as the speed of publication. It is my pleasure to continue with this scientific relationship with the esteem JWHCI.
This is an acknowledgment for peer reviewers, editorial board of Journal of Clinical Research and Reports. They show a lot of consideration for us as publishers for our research article “Evaluation of the different factors associated with side effects of COVID-19 vaccination on medical students, Mutah university, Al-Karak, Jordan”, in a very professional and easy way. This journal is one of outstanding medical journal.
Dear Hao Jiang, to Journal of Nutrition and Food Processing We greatly appreciate the efficient, professional and rapid processing of our paper by your team. If there is anything else we should do, please do not hesitate to let us know. On behalf of my co-authors, we would like to express our great appreciation to editor and reviewers.
As an author who has recently published in the journal "Brain and Neurological Disorders". I am delighted to provide a testimonial on the peer review process, editorial office support, and the overall quality of the journal. The peer review process at Brain and Neurological Disorders is rigorous and meticulous, ensuring that only high-quality, evidence-based research is published. The reviewers are experts in their fields, and their comments and suggestions were constructive and helped improve the quality of my manuscript. The review process was timely and efficient, with clear communication from the editorial office at each stage. The support from the editorial office was exceptional throughout the entire process. The editorial staff was responsive, professional, and always willing to help. They provided valuable guidance on formatting, structure, and ethical considerations, making the submission process seamless. Moreover, they kept me informed about the status of my manuscript and provided timely updates, which made the process less stressful. The journal Brain and Neurological Disorders is of the highest quality, with a strong focus on publishing cutting-edge research in the field of neurology. The articles published in this journal are well-researched, rigorously peer-reviewed, and written by experts in the field. The journal maintains high standards, ensuring that readers are provided with the most up-to-date and reliable information on brain and neurological disorders. In conclusion, I had a wonderful experience publishing in Brain and Neurological Disorders. The peer review process was thorough, the editorial office provided exceptional support, and the journal's quality is second to none. I would highly recommend this journal to any researcher working in the field of neurology and brain disorders.
Dear Agrippa Hilda, Journal of Neuroscience and Neurological Surgery, Editorial Coordinator, I trust this message finds you well. I want to extend my appreciation for considering my article for publication in your esteemed journal. I am pleased to provide a testimonial regarding the peer review process and the support received from your editorial office. The peer review process for my paper was carried out in a highly professional and thorough manner. The feedback and comments provided by the authors were constructive and very useful in improving the quality of the manuscript. This rigorous assessment process undoubtedly contributes to the high standards maintained by your journal.
International Journal of Clinical Case Reports and Reviews. I strongly recommend to consider submitting your work to this high-quality journal. The support and availability of the Editorial staff is outstanding and the review process was both efficient and rigorous.
Thank you very much for publishing my Research Article titled “Comparing Treatment Outcome Of Allergic Rhinitis Patients After Using Fluticasone Nasal Spray And Nasal Douching" in the Journal of Clinical Otorhinolaryngology. As Medical Professionals we are immensely benefited from study of various informative Articles and Papers published in this high quality Journal. I look forward to enriching my knowledge by regular study of the Journal and contribute my future work in the field of ENT through the Journal for use by the medical fraternity. The support from the Editorial office was excellent and very prompt. I also welcome the comments received from the readers of my Research Article.
Dear Erica Kelsey, Editorial Coordinator of Cancer Research and Cellular Therapeutics Our team is very satisfied with the processing of our paper by your journal. That was fast, efficient, rigorous, but without unnecessary complications. We appreciated the very short time between the submission of the paper and its publication on line on your site.
I am very glad to say that the peer review process is very successful and fast and support from the Editorial Office. Therefore, I would like to continue our scientific relationship for a long time. And I especially thank you for your kindly attention towards my article. Have a good day!
"We recently published an article entitled “Influence of beta-Cyclodextrins upon the Degradation of Carbofuran Derivatives under Alkaline Conditions" in the Journal of “Pesticides and Biofertilizers” to show that the cyclodextrins protect the carbamates increasing their half-life time in the presence of basic conditions This will be very helpful to understand carbofuran behaviour in the analytical, agro-environmental and food areas. We greatly appreciated the interaction with the editor and the editorial team; we were particularly well accompanied during the course of the revision process, since all various steps towards publication were short and without delay".
I would like to express my gratitude towards you process of article review and submission. I found this to be very fair and expedient. Your follow up has been excellent. I have many publications in national and international journal and your process has been one of the best so far. Keep up the great work.
We are grateful for this opportunity to provide a glowing recommendation to the Journal of Psychiatry and Psychotherapy. We found that the editorial team were very supportive, helpful, kept us abreast of timelines and over all very professional in nature. The peer review process was rigorous, efficient and constructive that really enhanced our article submission. The experience with this journal remains one of our best ever and we look forward to providing future submissions in the near future.
I am very pleased to serve as EBM of the journal, I hope many years of my experience in stem cells can help the journal from one way or another. As we know, stem cells hold great potential for regenerative medicine, which are mostly used to promote the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives. I think Stem Cell Research and Therapeutics International is a great platform to publish and share the understanding towards the biology and translational or clinical application of stem cells.
I would like to give my testimony in the support I have got by the peer review process and to support the editorial office where they were of asset to support young author like me to be encouraged to publish their work in your respected journal and globalize and share knowledge across the globe. I really give my great gratitude to your journal and the peer review including the editorial office.
I am delighted to publish our manuscript entitled "A Perspective on Cocaine Induced Stroke - Its Mechanisms and Management" in the Journal of Neuroscience and Neurological Surgery. The peer review process, support from the editorial office, and quality of the journal are excellent. The manuscripts published are of high quality and of excellent scientific value. I recommend this journal very much to colleagues.
Dr.Tania Muñoz, My experience as researcher and author of a review article in The Journal Clinical Cardiology and Interventions has been very enriching and stimulating. The editorial team is excellent, performs its work with absolute responsibility and delivery. They are proactive, dynamic and receptive to all proposals. Supporting at all times the vast universe of authors who choose them as an option for publication. The team of review specialists, members of the editorial board, are brilliant professionals, with remarkable performance in medical research and scientific methodology. Together they form a frontline team that consolidates the JCCI as a magnificent option for the publication and review of high-level medical articles and broad collective interest. I am honored to be able to share my review article and open to receive all your comments.
“The peer review process of JPMHC is quick and effective. Authors are benefited by good and professional reviewers with huge experience in the field of psychology and mental health. The support from the editorial office is very professional. People to contact to are friendly and happy to help and assist any query authors might have. Quality of the Journal is scientific and publishes ground-breaking research on mental health that is useful for other professionals in the field”.
Dear editorial department: On behalf of our team, I hereby certify the reliability and superiority of the International Journal of Clinical Case Reports and Reviews in the peer review process, editorial support, and journal quality. Firstly, the peer review process of the International Journal of Clinical Case Reports and Reviews is rigorous, fair, transparent, fast, and of high quality. The editorial department invites experts from relevant fields as anonymous reviewers to review all submitted manuscripts. These experts have rich academic backgrounds and experience, and can accurately evaluate the academic quality, originality, and suitability of manuscripts. The editorial department is committed to ensuring the rigor of the peer review process, while also making every effort to ensure a fast review cycle to meet the needs of authors and the academic community. Secondly, the editorial team of the International Journal of Clinical Case Reports and Reviews is composed of a group of senior scholars and professionals with rich experience and professional knowledge in related fields. The editorial department is committed to assisting authors in improving their manuscripts, ensuring their academic accuracy, clarity, and completeness. Editors actively collaborate with authors, providing useful suggestions and feedback to promote the improvement and development of the manuscript. We believe that the support of the editorial department is one of the key factors in ensuring the quality of the journal. Finally, the International Journal of Clinical Case Reports and Reviews is renowned for its high- quality articles and strict academic standards. The editorial department is committed to publishing innovative and academically valuable research results to promote the development and progress of related fields. The International Journal of Clinical Case Reports and Reviews is reasonably priced and ensures excellent service and quality ratio, allowing authors to obtain high-level academic publishing opportunities in an affordable manner. I hereby solemnly declare that the International Journal of Clinical Case Reports and Reviews has a high level of credibility and superiority in terms of peer review process, editorial support, reasonable fees, and journal quality. Sincerely, Rui Tao.
Clinical Cardiology and Cardiovascular Interventions I testity the covering of the peer review process, support from the editorial office, and quality of the journal.
Clinical Cardiology and Cardiovascular Interventions, we deeply appreciate the interest shown in our work and its publication. It has been a true pleasure to collaborate with you. The peer review process, as well as the support provided by the editorial office, have been exceptional, and the quality of the journal is very high, which was a determining factor in our decision to publish with you.
The peer reviewers process is quick and effective, the supports from editorial office is excellent, the quality of journal is high. I would like to collabroate with Internatioanl journal of Clinical Case Reports and Reviews journal clinically in the future time.
Clinical Cardiology and Cardiovascular Interventions, I would like to express my sincerest gratitude for the trust placed in our team for the publication in your journal. It has been a true pleasure to collaborate with you on this project. I am pleased to inform you that both the peer review process and the attention from the editorial coordination have been excellent. Your team has worked with dedication and professionalism to ensure that your publication meets the highest standards of quality. We are confident that this collaboration will result in mutual success, and we are eager to see the fruits of this shared effort.
Dear Dr. Jessica Magne, Editorial Coordinator 0f Clinical Cardiology and Cardiovascular Interventions, I hope this message finds you well. I want to express my utmost gratitude for your excellent work and for the dedication and speed in the publication process of my article titled "Navigating Innovation: Qualitative Insights on Using Technology for Health Education in Acute Coronary Syndrome Patients." I am very satisfied with the peer review process, the support from the editorial office, and the quality of the journal. I hope we can maintain our scientific relationship in the long term.
Dear Monica Gissare, - Editorial Coordinator of Nutrition and Food Processing. ¨My testimony with you is truly professional, with a positive response regarding the follow-up of the article and its review, you took into account my qualities and the importance of the topic¨.
Dear Dr. Jessica Magne, Editorial Coordinator 0f Clinical Cardiology and Cardiovascular Interventions, The review process for the article “The Handling of Anti-aggregants and Anticoagulants in the Oncologic Heart Patient Submitted to Surgery” was extremely rigorous and detailed. From the initial submission to the final acceptance, the editorial team at the “Journal of Clinical Cardiology and Cardiovascular Interventions” demonstrated a high level of professionalism and dedication. The reviewers provided constructive and detailed feedback, which was essential for improving the quality of our work. Communication was always clear and efficient, ensuring that all our questions were promptly addressed. The quality of the “Journal of Clinical Cardiology and Cardiovascular Interventions” is undeniable. It is a peer-reviewed, open-access publication dedicated exclusively to disseminating high-quality research in the field of clinical cardiology and cardiovascular interventions. The journal's impact factor is currently under evaluation, and it is indexed in reputable databases, which further reinforces its credibility and relevance in the scientific field. I highly recommend this journal to researchers looking for a reputable platform to publish their studies.
Dear Editorial Coordinator of the Journal of Nutrition and Food Processing! "I would like to thank the Journal of Nutrition and Food Processing for including and publishing my article. The peer review process was very quick, movement and precise. The Editorial Board has done an extremely conscientious job with much help, valuable comments and advices. I find the journal very valuable from a professional point of view, thank you very much for allowing me to be part of it and I would like to participate in the future!”
Dealing with The Journal of Neurology and Neurological Surgery was very smooth and comprehensive. The office staff took time to address my needs and the response from editors and the office was prompt and fair. I certainly hope to publish with this journal again.Their professionalism is apparent and more than satisfactory. Susan Weiner
