Fast Track Review Research Articles

Expedited program and utilization for anticancer drug approval in China and the United States

Objective: To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021. Methods: Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison. Results: Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P＜0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions: Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.

Global Framework for Scientific Event: A 32-Country and 118-Expert Collaborative Effort

Introduction Despite numerous efforts to define and categorize scientific events, a consensus remains elusive, complicating the understanding and classification of such events. The current study aims to establish clear, consensus-based definitions for various types of scientific events by examining their definitions and purposes from the perspectives of scholars across different countries. Methods The current study used a descriptive survey design to gather responses from scholars across 32 countries about their perceptions of scientific events. The sample size was determined using G*power, requiring 80 participants; 118 were recruited. Data was collected via a Google Forms survey with a 9-point Likert scale. Invitations were emailed. The Content Validity Index (CVI) was used to assess item relevance, with all items achieving a CVI above 0.78. Data analysis involved descriptive statistics, and ethical considerations regarding voluntary participation and confidentiality were observed. Results This study validated the definitions of ten event types, each achieving a CVI above 0.78. The scientific events were categorized into conferences, symposiums, workshops, courses, summits, panels, meetings, fast-track reviews, annual reviews, and seminars. Course and panel garnered the highest level of consensus with a CVI of 0.983. Fast-track review also demonstrated a strong agreement among participants, with 82.2% expressing their concurrence with the provided definition. Conclusion The study establishes consensus-based definitions for scientific events, enhancing standardization in the academic community and underscoring the importance of precise categorization.

Clinical research in hospital pharmacy during the fight against COVID-19

The health crisis resulting from the rapid spread of SARS-CoV-2 worlwi-de, added to the low evidence of currently used treatments has led to the development of a large number of clinical trials (CT) and observational studies. Likewise, important measures have been adopted in healthcare and research centers aimed at halting the pandemic as soon as possible.The objective of this study is to gather the main aspects of the clinical research studies undertaken by the Pharmacy Department (PD) of Spain during the COVID-19 crisis.The decision of the Spanish Society of Hospital Pharmacy (SEFH) to sponsor CTs made it possible that 13% of Pharmacy Department (PD) had been led at least one CT. The Spanish Agency for Medicines and Medical Devices (AEMPS), in coordination with Institutional Review Boards, has adopted a fast-track review procedure to accelerate authorizations for CTs related to the treatment or prevention of COVID-19. There have also been numerous public and private calls for financing research projects aimed at contributing to the fight against this virus.Despite the pandemic, actions have been taken to continue ongoing CTs and studies while the safety and well-being of patients are guaranteed. More specifically, the AEMPS and the European Medicines Agency (EMA) have issued guidelines that incorporate changes to CT protocols that will have to be applied until the pandemic is over.In this health emergency, the scientific community has found itself in a race against time to generate evidence. It is at this moment that hospital pharmacists emerge as key players in clinical research and are contributing to a rational, effective and safe healthcare decision-making.

Challenges faced in the peer review system in open access journals

Challenges faced in the peer review system in open access journals

Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

The US Food and Drug Administration (FDA) has 4 programs that can be used alone or in combination to expedite drug availability: Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review. Drugs using these programs can include novel drugs, which do not contain a previously FDA-approved active moiety, and orphan drugs, intended for diseases or conditions affecting fewer than 200 000 people; to date, no comprehensive evaluation of how these programs have been used in combination has been published. To assess how often and in what combinations expedited programs are used in the development and review of approved novel biologics and small-molecule drugs, stratified by orphan drug status and indication. This cross-sectional study evaluated all novel drugs that were FDA approved between January 1, 2008, and December 31, 2021. The main outcome was the frequency with which expedited programs were used and in what combinations, stratified by orphan drug status and drug type (small molecule vs therapeutic biologic). The unit of analysis was the novel drug-indication pair because a drug can be approved for multiple indications, each of which may use a different expedited program or differ in orphan drug status. The study included 581 novel drug-indication pairs approved during the 14-year study period; 252 (43.4%) were orphan drugs, 139 (23.9%) were therapeutic biologics, and 442 (76.1%) were small-molecule drugs. Use of at least 1 expedited program increased from 11 of 26 drug-indication pairs (42.3%) in 2008 to 41 of 55 (74.5%) in 2021. Of the 363 approved drug-indication pairs using at least 1 expedited program, 225 (62.0%) were orphan drugs; at least 1 expedited program was used by 97 of the 139 approved biologic drugs (69.8%) and by 266 of the 442 approved small-molecule drugs (60.2%). Eighty-two of the 581 novel drug-indication pairs (14.1%) used the Accelerated Approval Program; of those, 65 (79.3%) were oncology drugs and 70 (85.4%) had an orphan designation. The study showed that use of the FDA's expedited programs to bring novel drugs to market in the US increased from 2008 to 2021. The findings suggest that this trend is likely to continue.

An invitation to association of physicians' fellows from the Quarterly Journal of Medicine (QJM).

The Quarterly Journal of Medicine (QJM) is the official Journal of the Association of Physicians of Great Britain & Ireland (www.aopgbi.org). We extend an invitation to our members to consider submitting topical commentary pieces, reviews and original research manuscripts to their Journal. We live in a highly competitive scientific global environment and now that our impact factor has increased to 14.04, we believe that the QJM now offers a suitable platform to share your original work with the global scientific community. For potentially high-impact papers, we offer a fast-track review service, ×72 h to first decision. Should you wish to avail of this facility, authors are encouraged to liaise in advance with Professor Seamas Donnelly, Editor-in-Chief for the journal at seamas.donnelly@tcd.ie. We also welcome suggestions from our members on how we can further improve the Journal. The QJM has been at the forefront of providing a platform for the highlighting of the range of side effects associated with coronavirus disease 2019 (COVID-19) vaccinations.1–8

QJM Impact Factor now 14.04.

The Quarterly Journal of Medicine (QJM) is pleased to announce the current Impact Factor for the Journal is now 14.04. The QJM is the official Journal of the Association, founded in 1907 by Sir William Osler, and it has a significant legacy of publishing leading articles in Translational Medicine. The Journal welcomes submission of original medical research articles, invited reviews and topical Commentary pieces relevant to our medical audience. We would encourage our readers to consider submitting their novel original work to the Journal. We offer a fast-track review process for selected original article submissions, namely 72 h (×3 working days) to first review decision. Should you wish to avail of this service, authors are encouraged to liaise in advance with Professor Seamas Donnelly, Editor-in-Chief, for the journal at qjm.editorialoffice@oup.com. The QJM has been at the forefront of publishing highly topical articles on the epidemiology, prognosis and long-term consequences of acute COVID-19 infection.1,2,3,4,5,6 A robust host defense against infectious disease involves both viral resistance and tolerance. Integration of clinical, immunologic, genetic and therapeutic discoveries has identified defects in both of these responses in the progression from SARS-CoV-2 infection to life-threatening coronavirus. We welcome the topical review on this subject by Dr. Russell and colleagues from the University of Edinburgh, published in this issue of the Journal.

Ακράτεια ούρων και πτώσεις σε άτομα άνω των 60 ετών: βραχεία ανασκόπηση σύγχρονων ερευνητικών δεδομένων

Urinary incontinence and falls are important geriatric problems, affecting a high percentage of older people. Previous studies have established an association between urinary incontinence and falls in various aged groups. Βoth problems are associated with injuries and a decreased quality of life. Assessing the association between falls and other geriatric syndromes is clinically important in preventing falls. This is a fast track review of the current knowledge on urinary incontinence and falls in older adults

Time to inclusion in clinical guidance documents for non-oncological orphan drugs and biologics with expedited FDA designations: a retrospective survival analysis

ObjectivesDrug and biological products that treat rare, serious or life-threatening conditions can receive US Food and Drug Administration (FDA) orphan designation and expedited programme designations (accelerated approval, breakthrough therapy, fast...

Protocol of investigation into reporting quality of RCT abstracts on COVID-19 pursuant to CONSORT (CoCo study)\u2014a review

BackgroundIn 2020, the COVID-19 pandemic developed into a global crisis, the enormity and urgency of which accelerated research activities in the field. At the same time, manuscripts describing these research projects underwent fast-track peer review procedures and were published in freely accessible formats. Although full texts about COVID-19 are currently available for free, abstracts continue to play a key role since they provide essential information and possibly a decision basis for therapies. s are particularly important in case the full texts are not free, not all reports have been published in English and in emergency situations when there is less time for comprehensive analysis of all full texts. It is therefore necessary to ensure that abstracts—as publications in miniature format—contain comprehensive and transparent information. The CONSORT statement for abstracts (CONSORT-A) offers guidelines to authors how to include all necessary information in an abstract.Prior to the COVID-19 pandemic, the quality of reporting in medical research had already been the object of debate and criticism. The current crisis makes comprehensive documentation all the more important. s of COVID-19 RCTs should therefore report the criteria listed in the CONSORT-A statement fully and verifiably. The objective of this study is to check the completeness of abstracts of all COVID-19 RTCs published to date.MethodsBased on a literature search in PubMed, Embase and the Cochrane Library, all publications up to 29 October 2020 are identified and examined in terms of the subject matter (reported results from COVID-19 studies) and their study design (RTC). Subsequently, suitable publications are examined for completeness and quality of abstracts. The CONSORT checklist for RTC abstracts serves as a basis in this procedure. The primary endpoint of the study is the percentage of correctly implemented items of the CONSORT statement for abstracts. The frequency of correct reporting of each individual item is checked in a second step.DiscussionThe study is expected to contribute to evaluating the reporting quality on COVID-19 studies, and specifically the completeness of abstracts of RTCs. It may thus support the assessment of current research into COVID-19.Trial registrationRegistration was not required as the study investigated existing literature.

Just-in-Time Qualitative Research: Methodological Guidelines Based on the COVID-19 Pandemic Experience.

Methodological guidelines are required to ensure both the rigor and feasibility of just-in-time, qualitative research addressing the human experience and response to the COVID-19 pandemic and major public health crises. This article presents methodological guidelines for just-in-time qualitative research based on our current, pandemic-relevant research. The processes followed while conducting two longitudinal, online qualitative studies addressing the lived experience and response to the COVID-19 pandemic were analyzed. Methodological challenges faced were then identified, and specific design and implementation guidelines were developed. The ways in which these guidelines can be applied to conduct just-in-time research during the COVID-19 pandemic and future public health crises were further delineated using examples from our pandemic-relevant research. Six guidelines were identified: (a) capitalize on fast track review and reporting processes; (b) prioritize accessibility during sample specification and selection; (c) optimize recruitment and retention strategies; (d) maximize current and future data use through strategic research design; (e) tailor data collection to participants' characteristics, preferences, and priorities; and (f) incorporate timeline mapping of personal and contemporaneous phenomena. Public health measures taken to slow disease spread during the current COVID-19 pandemic and future public health crises may slow the pace of research and make its implementation all the more challenging. However, just-in-time qualitative research advances our understanding of the human experience and response to the COVID-19 and major public health crises. It also complements existing behavioral theory and research. The guidelines presented may assist researchers to initiate necessary qualitative research more rapidly, with fewer logistic challenges, and with methodological rigor. They may also help expand research on groups experiencing collateral effects of the pandemic and major public health crisis. Lastly, the guidelines may support the development of more robust data for alternate analysis at a later date.

Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

Plain English summaryPatient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research.During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public.In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future.Background:Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial.Methods:RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference.Results:Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice.Conclusions:PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.

The impact of COVID-19 pandemic on research

The impact of COVID-19 pandemic on research

Tafamidis: A Novel Treatment for Transthyretin Amyloid Cardiomyopathy.

Transthyretin (TTR) amyloid cardiomyopathy is a life-threatening condition in which amyloid fibrils accumulate in the heart, eventually leading to cardiac symptomatology and death. To date, treatment of this condition has been directed at symptom relief due to a lack of effective treatment options which target the cause of the disease. The discovery that amyloid deposition was a result of dissociation of the TTR protein structure allowed for the development of tafamidis, which acts by stabilizing the TTR tetramer. Due to the rare nature of the disease, there is limited clinical trial data with tafamidis, with the largest clinical trial enrolling only 441 patients. Nonetheless, that trial demonstrated tafamidis to reduce all-cause mortality as well as cardiovascular hospitalizations compared to placebo with a comparable adverse effect profile, although not all subgroups of patients received benefit. The United States Food and Drug Administration subsequently granted Fast Track review status to tafamidis, leading to its approval in May 2019. Important questions still remain, however, such as which patient groups will receive the most benefit with this drug, how the exceptionally high cost of the drug will be handled by third-party payers, and how the therapeutic role of tafamidis will evolve as competing or perhaps complementary medications complete their ongoing clinical trials and move into the marketplace.

Relationship Between Metformin Use and Lactic Acidosis in Advanced Chronic Kidney Disease: The REMIND-TMU Study

Background: Although current guidelines only suggest that metformin is safe with an estimated glomerular filtration rate (eGFR) of >30 ml/min/1.73 m 2 due to increased risk of lactic acidosis, [1] evidence of metformin-associated lactic acidosis (MALA) has been limited due to insufficient case numbers. Up to 27.6% of patients with advanced chronic kidney disease (CKD) were still treated with metformin in real world practice. [2] It is necessary to investigate the incidence of laboratory-defined MALA in advanced CKD. Methods: This study used data from Taipei Medical University (TMU) and its affiliated hospitals, which was a three million population-based, long-term, propensity score-matched cohort study based on clinical data from 2008 to 2016. Adults with type 2 diabetes and advanced CKD were stratified according to being metformin users or non-users. The primary outcome was laboratory-defined lactic acidosis (serum pH of 5mmol/L). Relationships between the probability of MALA and various eGFR values in advanced CKD patients are also presented in regression analysis. Findings: In total, 12,850 adults with type 2 diabetes whose eGFR was <30 ml/min/1.73 m 2 were enrolled in this study out of a database consisting of 3,305,711 persons. After the process of propensity score matching, 7707 patients were divided into metformin and non-metformin groups. In linear regression model, metformin significantly increased the risk of lactic acidosis ( p =0.0204) as the eGFR declined in advanced CKD over a mean follow up of over 600 days after confounder adjustment with age, sex and comorbidities. Interpretations: Metformin significantly increased risk of lactic acidosis as renal function declined in advanced CKD even after confounder adjustment. This “REMIND” study reminds us that metformin should be avoided in advanced CKD due to a significantly increased risk of lactic acidosis as renal function declined. Funding Statement: This study was partially supported by Center for Drug Evaluation, Taiwan (grant number: RC1051115) and Taipei Municipal Wanfang Hospital (managed by Taipei Medical University) (grant number: 107TMU-WFH-07). Declaration of Interest: The authors declare no competing interests. Ethics Approval Statement: The study has the approval of fast track review by TMU institutional review board (TMU-JIRB no. IRB N201709052).

FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis.

Breast cancer is the most common cancer in women worldwide and the solid tumor type for which the highest number of drugs have been approved to date. This study examines new drug approvals for breast cancer by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018. Of the 29 breast cancer drugs approved over this time span, 17 received positive decisions from both the FDA and EMA, including all drugs licensed after 2008. Nineteen of the 25 FDA-approved drugs, but none of the EMA approvals, benefited from special regulatory pathways (such as fast track, breakthrough therapy, or priority review). In the U.S.A., four accelerated approvals were granted (of which one, for bevacizumab, was later revoked), while only two drugs received provisional approvals following EMA review. New breast cancer drugs were approved approximately twelve months earlier in the United States than in Europe. These results suggest that a broader use of special regulatory pathways by EMA could help to accelerate access to novel drugs for European breast cancer patients.

Trends in FDA drug approvals over last 2 decades: An observational study.

Introduction:The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important goal. Systematic investigation and comprehensive analysis of approved drugs could provide valuable insights into trends in the discovery and may contribute to further discovery of newer drugs systematically. Food and drug administration (FDA's) Center for Drug Evaluation and Research (CDER) every year summarizes novel drugs, some of which are truly innovative and help in advancing clinical care. This study was conducted to find a trend in drug approvals by FDA in the last 2 decades. Awareness of these new drugs amongst the primary care physicians is also crucial as they have been prescribing these agents in the past.Methodology:In this cross-sectional study, we collected, surveyed, and analyzed drugs approved by U.S. Food and Drug Administration (USFDA) from the year 2000 till 2017 identified from ClinicalTrials.gov and online database of FDA. Drugs approved every year were assessed for total number, class of drug, indication, and category of approval. Type of accelerated regulatory pathways and reasons for speedy approvals every year were also studied. Microsoft Office Excel 2007 was used for tabulation and analysis.Results:Total 209 were approved from 2000 to 2008. Out of these 9.09% were indicated for cardiovascular disorders and 12.91% for neurological disorders. Antibiotics (5.26%) and antivirals (5.74%) were least contributed, whereas anticancer drugs (11.96%) and biologics (7.17%) approval remained constant. Whereas, out of three hundred and two drugs approved during 2009--2017, 5.29% were for cardiovascular disorders, 9.93% for neurological disorders. Antibiotics (5.29%) and antivirals (5.96%) were least in number, whereas anticancer drugs (17.54%) and biologics (15.56%) approval took a steep rise in these years. Also, a wide variation in the number and category of approval was observed over a period of years. The use of fast track, accelerated approval, and priority review programs have also been steadily increasing since 2000.Conclusion:There has been a steady rate of introduction of new drugs by CDER over the last two decades. Expedited approval of anticancer and biologics is seen as recent trend in drug development. Relatively, slow progress in approval of drugs for neurological disorders (depression, psychosis, multiple sclerosis, etc.) and lifestyle diseases like obesity, atherosclerosis, diabetes, etc., were seen. These findings reflect more emphasis being laid down in research for anticancer drugs and biologics.

JFAR Editor's Message

As the new editor of the Journal of Forensic Accounting Research (JFAR), I will continue prior efforts set by the past editor, Professor Charles D. Bailey, to expand the journal's scope while simultaneously improving the quality and increasing the number of submissions to get ranking—the Impact Factor—for the JFAR. To accomplish this goal, I have commissioned several special issues on “fraud,” “non-fraud,” “behavioral,” and “digital forensics.” Calls for papers for these special topics for the JFAR's consideration and publication are posted on the websites of the American Accounting Association (AAA) and the Forensic Accounting Section (FAS). We are reaching out to our global colleagues to consider submitting to this fast-track review for special topics of the JFAR. Please contact the issues' editors for more detailed information about special issues with your suggestions, comments, and proposals. Below is a synopsis of the call for these special topics:I have attended several conferences nationally and internationally this year in promoting the JFAR including:As of now, this year we have two accepted manuscripts in production, several revised and resubmitted for regular submission, and eight submissions for the Special Forum in “Non-Fraud Forensic Accounting.” We plan to publish at least 15 articles in the Spring of 2020 issue of the JFAR.I truly appreciate the cooperation and efforts of the leadership of the FAS, past editor, associate editors of the JFAR, and the staff of AAA in making our journal one of the premier AAA journals. When we are successful with our initiatives, we will be able to build a case for inclusion in the indexes. I suggest considering the Social Science Citation Index (SSCI) to get the Impact Factor soon. To take the journal international, we need to get ranking in international and regional databases including SSRN, Web of Science, Scopus, CABS (U.K.), ABDC (Australia), CNRS (France), and VHB (Germany), among others. Please do not hesitate to contact me if you have any suggestions for maintaining the sustainability of the JFAR. I am counting on your support!Best regards and Happy Holidays,—Zabihollah RezaeeEditor

Too Much Carrot and Not Enough Stick in New Stem Cell Oversight Trends.

Regulators are now more often distinguishing between perceived good citizens and "bad actors" in stem cell and regenerative medicine clinical research, resulting in relatively more polar, carrot-and-stick oversight approaches. Here, I discuss why there may be too much carrot and not enough stick by regulators for effective enforcement.

Editorial

Scientific research is progressing rapidly in a dramatic pace. Research productivity in terms of publications, product development, and citations have become key performance indicators in the assessment of higher education institutions (HEIs) and individual researchers. Most HEIs have adopted rigorous recruitment processes to hire research-oriented faculty and implemented various programs to train, support, recognize, and retain productive researchers. The academic community has realized that it cannot survive without research and publishing excellence. They are experiencing institutional pressure to produce an annual minimum number of publications as mandatory requirement to secure their job, as well as to satisfy the essential promotion criterion for number publications in prescribed journals. On the other hand, a huge number of candidates are getting enrolled for master, doctoral, and postdoctoral programs in various universities around the globe. Most of these candidates have different types of commitments and constrains to finish their programs within a preset timeframe. When publication in prescribed journals becomes mandatory for submission of thesis/dissertation, the candidates undergo severe stress due to the desperate delay in getting their works published. Moreover, as the scientific innovations are progressing rapidly and competitively, any delay in publishing can make novel findings outdated, which obviously creates a serious damage to the researcher's career. At this juncture, there is a growing concern among the researchers regarding timely publication of their research findings. This situation has been exploited by many commercial open access publishers by offering fast-track review process. However, their high processing charge is unaffordable for many authors, International Journal of Advanced Thermofluid Research. 2018. 4(1):1-2. Timely completion of review process – journals' basic responsibility Abdul Mujeebu 2 who do not have a funding source. With the aggressive penetration of these publishers in the market, most leading free-of-charge publishers are struggling to survive. To tackle this, they have come up with hybrid publishing mode, where authors can choose either open access (payable) or subscription (free) mode. Unfortunately, the article processing and peer-review in the second option have nowadays become unacceptably slow. It is often experienced that submissions remain unattended for many weeks waiting for administrative process, and status shows 'with editor' for over a month and 'under review' for even up to one year. I have recently withdrawn more than three submissions when they were kept 'with editor' for over two months without sending for peer review. It becomes more tragic when these journals do desk-rejection after keeping submissions for months simply by citing the reason that the paper is 'out of scope'. A simple question arises: do they need more than two months to check the scope of submission? Another level of negligence from the journals (mainly editors) has been noticed by holding submissions under the status "required reviews completed" or "decision in process" for unreasonably long period. It becomes more hurting to the authors when editors express "disapproval" when they receive polite reminders. Having said this, one cannot ignore the performance of many journals that are really responsible in their dealings. The editors have a great role to play here to keep the editorial team dynamic, proactive, and author friendly. Let us hope that the editors and publishers give due attention to this issue by adopting a strategic policy to complete the review process within a reasonable predeclared time. Dr. M. Abdul Mujeebu Editor-in-Chief, IJATR