Clinical Research - Science topic

Anitha Roshan Sagarkar Although the said were exactly correct, not in all cases the results with p value and confidence can be relied upon directly. However, it is important to note that they should not be the sole determinants of reliability.

Assessing the risk of bias (RoB) is also essential when evaluating clinical trial outcomes. Studies with a high risk of bias should be approached cautiously, as their results may be less reliable, potentially reflecting errors or systematic issues. Conversely, even if a study's p-value indicates statistical insignificance, it can still be worth considering for clinical application if the risk of bias is low, and the sample size is robust. In such cases, a well-designed trial with minimal bias may offer more credible and actionable insights, supporting clinical replication despite the lack of statistical significance.

Video-Assisted Thoracic Surgery, Video-Thoracic Surgical Treatment of TB-Empyema

Yes, patient care and clinical research are closely related activities, each playing a crucial role in advancing healthcare.

Relationship between Patient Care and Clinical Research

I am skilled in Bioinformatics and would like to work with you, @Hussein Alaa. Reach me at anthonyimolele@gmail.com

Many thanks for your efforts!!! I will try it out as soon as possible and will provide feedback on github!

All the best,

Rainer

well,as António said, self-report or discover questionnaire could be useful, but it can't be quantified just using a sample tool such as 24-hour electrocardiogram monitoring,which could capture patient's heartbeat.

Patients received doctor's psychotherapy and behaved as doctor's expections for believes of doctor thinking it's effective and patients trusting doctor. I mean that transfer is between patients and doctor and others.

Certainly, there are several reputable websites and online resources dedicated to providing comprehensive details on clinical-based research. Here are some notable websites:

PubMed Central (PMC), ClinicalTrials.gov, Cochrane Library, Cochrane Library, The NIH website, UpToDate, European Medicines Agency (EMA), American College of Physicians (ACP), JAMA Network, BMJ (British Medical Journal), The WHO International Clinical Trials Registry Platform (ICTRP), among others.

Remember to critically evaluate the sources and consider the context and methodology of the studies you find on these platforms. Always consult with peers and experts in the field to ensure the validity and relevance of the information you gather.

Here are some widely recognized sleep quality questionnaires:

Pittsburgh Sleep Quality Index (PSQI): The PSQI is one of the most commonly used questionnaires for assessing overall sleep quality. It covers various aspects of sleep, such as sleep duration, latency, disturbances, and daytime dysfunction. It provides a comprehensive score of sleep quality.

Insomnia Severity Index (ISI): If your research focuses on insomnia specifically, the ISI is a useful tool for assessing the severity of insomnia symptoms. It covers the nature, severity, and impact of insomnia.

Sleep Disturbance Questionnaire (SDQ): The SDQ is a brief questionnaire used to assess sleep disturbances in clinical populations. It covers various aspects of sleep quality and disturbance.

Medical Outcomes Study Sleep Scale (MOS-Sleep): The MOS-Sleep questionnaire is a comprehensive instrument that assesses multiple dimensions of sleep, including sleep disturbance, sleep adequacy, and daytime somnolence.

Gaurav H Tandon Couln't agree more.

Hello Sherif Hammad , it is very interesting to read your question and feel your enthusiasm to start your academic journey. This question reminded me of myself back in 2018. I will provide you with some tips that helped me to be involved in the research community until now:

With pleasure, I can support you in your journey and I believe you have more capabilities than what you think.

Best wishes for you

This site is the UK research integrity office and it has advice for people in your situation, whistleblowers etc..

our Litiginous society has "evolved" with Big Pharma producing a plethora of "alternative facts" backed by profit and legal penalties.

A version of the truth is reported on every medicinal package in the fine print listing disclaimers which include a form of magical thinking that if we are aware of how the medicines are bad, then they can be good.

this helps nobody but big pharma, and it ensures that the psychiatric field is entangled with best practices that are not at all good.

The doyenne of Professors in the field is Dame Sarah Gilbert at Oxford who was one of the main producers of the Astra-Zeneca Covid 19 vaccine and other spike protein vaccines for corona viruses before that. Having reviewed her department's protocols for an ethics committee, I can say that her projects are impressively done.

in which location you want to study

We have used the word efficacy for some nutrient media that are used in the Microbiology and Public Health laboratory for the isolation of organism from the clinical and environmental samples.

Risks associated with your specific clinical trial should be thoroughly explained to you during the informed consent process. This process adheres to the ICH-GCP principles which protect the rights and safety of subjects.

Research should begin with an educated idea arising from a clinical practice issue. A research topic rooted in a clinical problem provides the motivation for the completion of the research and relevancy for affecting medical practice changes and improvements. The research idea is further informed through a systematic literature review, clarified into a conceptual framework, and defined into an answerable research question. Engagement with clinical experts, experienced researchers, relevant stakeholders of the research topic, and even patients can enhance the research question's relevance, feasibility, and efficiency.

Planning and Conducting Clinical Research: The Whole Process - PubMed (nih.gov)

Consort - Welcome to the CONSORT Website (consort-statement.org)

thanks for the information. I am right now digging into a few areas, need to narrow it down to one or two. I am too curious and have an interest in adverse events reporting. I will definitely look more into it. Danial Hassan

usually in behavioral research, first author and corresponding authors are given importance i guess. If you note that a faculty has given significant contribution to the overall work, second author or corresponding author would be appropriate i guess.

Hi James

Thanks for your help. This is not a live exam question.

kind regards

med watch forms in usa pvpi formsissued by cdsc and in clinical trial cioms form

Unfortunately, there is (as is so often the case in scientific research) no pre-determined answer for your question. You will have to consider, decide and substantiate the criteria for inclusion in your study. You might find this specific part of the Cochrane handbook you already consulted specifically helpful in the process:

https://training.cochrane.org/handbook/current/chapter-03

I was even more surprised after the comment by Deborah Jean Verran that no answers/comments have been made in the five years after that!

Dr Darel E Heitkamp raises a very interesting point. In my community, a lot of academic departments have followed the trends of radiology practices/facilities in the private sector and have lost the "ethos" that was highlighted. The consultant/attending staff are pushed to report more and more. Nobody stands up, they just leave and take the "if you can't beat them, join them" approach. Those of us left behind get even more disillusioned.

Another value-add activity I have found is multi-disciplinary conferences.

Dear Dana Sultan, you can contact researches and demonstrate your related experiences and skills. Also, it is important to be participative and to have a CV. Also, you can continue your clinical practice and to participate from clinical researchers at the post-graduation programs.

Hello Dr Hassan H Kaabi.

we have done an extensive study on the relation between periodontal disease and many systemic diseases and we found that periodontal disease affects kidneys

Periodontitis had a significant direct effect, an indirect effect through diabetes, on the incidence of Chronic Kidney disease. Awareness about systemic morbidities from periodontitis should be realized

The American Academy of Periodontology (AAP)

has published a statement on kidney disease and tooth loss (periodontal disease)

Researchers Caution that Tooth Loss May Increase Risk of Chronic Kidney Disease in U.S. Adults

as for your questions about the selection of patients

dr Grubb Vanessa Grubbs, MD, an assistant professor and neprology specialist in the UC San Francisco's School of Medicine who is determined to advance this research as part of her commitment to preventing the chronic health problems associated with kidney disease.

you might want to contact he she can tell you how she selected patients

Dr Grubbsince 2013 has published that paper and i have attached it, it really shows you how she selected her patients and you might want to look at it even copy the method

the title of the paper is The association of periodontal disease with kidney

i also attached a 2021 paper on the topic, good luck in your study that is a very important topic

sincerely

Dr.K.A.Galil.Professor of Medicine and Professor of Dentistry DDS.,D.Oral & Maxillofacial Surgery ,PH.D,FAGD.,FADI.,Cert.Periodontist(Uof Michigan) (Royal College Dent Surg.Ont) Departments of Periodontics,Orthodontics and Clinical Anatomy Schulich School Of Medicine and Dentistry. University of Western Ontario, London,Ontario.

Thank you Ajit

Kristopher J. Brown Thanks!

You can try Mendeley. It is very handy. Freely available.

In general, the difference between IV and CVAD must be confirmed in animal before human kinetics. In addition, the difference is influenced by the kind of drug.

We must consider it based on scientific data only.

Although the content is good at explaining theoretical aspects of clinical research, I am not sure if the certification could be a plus in the CV. I took my chances and will see if it can be used as a hint in further PhD opportunities

Assessing clinical trial–associated workload in community-based research programs using the ASCO clinical trial workload assessment tool

Marjorie J Good, Patricia Hurley, Kaitlin M Woo, Connie Szczepanek, Teresa Stewart, Nicholas Robert, Alan Lyss, Mithat Gönen, Rogerio Lilenbaum

Journal of oncology practice 12 (5), e536-e547, 2016

Yes , I would be collaborate in reproductive research especially in the field of Male infertility and we can share our data for planed study project in this field

@Aldo P. Thank you. I think Health care workers around the world should be saluted and appreciated in many ways for the selfless acts of humanity we have all illustrated during these unspeakable times. Thank you for your service.

Hey Lawson, it depends on what principles you would use for the data analysis.

If you adopt the ‘per-protocol analysis’ that means only the data of subjects who have completed two time-points measurements will be used for the effects evaluation. Then you need to exclude the dropouts when calculating the effect sizes.

But if you use ‘intention-to-treat’ principles, you need to include all subjects (both completers and dropouts) in the data analysis.

Hope it would be helpfu.

When a book is being written, the author cites suitable research work related to the topic of the textbook. If the research has significant findings pertinent to the subject being written in the textbook, it will get cited. If many researchers are working on the same subject and consenses builds up or the experts in the field discuss the findings of the research and concur, it gets accepted by the scientific community and becomes standard of care and gets included in textbooks.

Hi Christian,

In this situation, conducting a mixed-effects logistic regression including 'Group' (3 levels), and 'Time' with two levels (i.e., time1, time2) is the only approach I can think of. It will be important to give 'Subject' a random intercept in the model as well since the same individuals are being measured twice (1|Subject).

If you're familiar with R software, you can conduct such an analysis using the lmer() function. Something along these lines:

model <- lmer(DV ~ Group + Time + (1|Subject), data = data)

-Blaine

Very interesting question, worth following.

I think a good approach would be to bin the data. You can bin the data into three groups (or into however you want) that will have almost equal proportions. You can then describe the three bins according to their relative angle (e.g. anterior, posterior, etc).

Thanks

The Appropriate test for comparison between each two groups is Chi square test. For the comparison among all groups kruksal walas test can be used to give a result that there is a significant difference among the groups.

I had a research in applied AI and develop several AI models for clinical applications. Also, I plan to use AI in the future to support physicians in the clinical decision making.

The problems I observed so far are mainly related to two areas:

a) the lack of correctly annotated data (initial data to use for training of AI models)

b) the black-box nature of AI models demands for human input in the clinical decisions

The good thing is that the modern approaches like active learning and explainable AI answer (partially) the above mentioned problems.

I cannot direct you to a document specific to India, but I located an organization in India that provides GCP training. See the link below.

I think you can show an association of the clinical variable with your disease state using linear/logistic regression and calculate Odd Ratio (OR). In addition, you may carry on same for other test, and compare their ORs. It does not need to test sensitivity, precision, and accuracy as like diagnostic tool (i.e., ROC-AUC). It would be supportive for follow-up experiments.

Hi Sir....As discussed above, you can always revisit the effect size (Cohen's d) taken for the sample size calculation. Taking a very large effect size may yield a very low sample size. using G power software will help you to calculate precise effect size and sample size for the your study.

Thanks

From your description of the trial it looks to me like you made the decision to continue based on reasonable criteria and hence that should be approximately equivalent to any other reason to continue so I would not expect any changes to your final analysis plan. I am not an expert on these trials so I would defer to someone who is. Best wishes, David Booth PS since I do not know what the trial is about I assume that you have considered any relevant safety issues to the participants. If not, then I think you should.

Actually, must be one of the authors , or at least will be get attention in the article like acknowledgment to emphasis about the role of idea generator , but my opinion , must be one of the authors

STOP-BANG Questionnaire is more reliably and easier to use

It might need an endorsement from the author(s). Using international validated tools as the guidelines on http://www.equator-network.org is a good way to create the check-list of the plain-language summaries. Hopefully one day the guidelines incorporate this on their checklist

Absolutely not

Statistics is indisputable for any clinical research.

Any clinical intervention should be based on rational scientific evidence to verify its benefit and to avoid harm. Empirical evidences from the accumulation of personal experiences are not acceptable, since the probability of recurrence of the outcome could not be quantified. Statistical methods are essential to quantify probabilities of events and to avoid (as much as possible) our inherent biases.

If ony neutrophil count is below the lower limit of normal while each of the other WBC are in the normal range you need to report only low neutrophil count as adverse event.

Hima - 'authenticity' is not just reliant on levels and degrees of blinding. More blinding does not necessarily equate to more rigour. Other factors - such as levels of control, randomisation are key. A well conducted single-blinded trial is better than a poorer double-blinded. If both a single and double-blinded study are of equal quality - I would argue no one is better than the other - as long as the context for the level of blindness is well rationalised and justified in each case.

Check out this resource- its the Short guide on how to maintain successful involvement in EU funded research-

Si!!! Hola! Soy oftalmóloga con maestría en investigación clínica. A sus órdenes

Dear Fazleh Mahomed

Its good question and delicate problem. I think some papers around this problem and available e-book may describe current situation:

https://www.sciencemag.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical doi:10.1126/science.aau6842

Best regards,

Tomasz

Hi Fadoua Khennou and Mohammad Mosa Daradkah thank you for answers.

Thank you very much !!

Have a good 2019

GD

Thank you so much for your response.@ Andrew Sutton

The duration and interval in drug treatment according .

1. Pharmaco kinetics of drug including t half protein binding,metabolism and excretion. Narrow therapeutic index or not.

2.Therapeutic condition is acute or chronic, age ,underlying disease, renal and hepatic function and does of drug is calculated accordingly.

I'm a cardiovasculer surgeon.Therefore I cant answer this guestion

Cardiovascular; Obesity; Metabolic and Bariatric Surgery

But, we are open to launch new projects based on your suggestions.

You can visit the following site which gives the list of international Clinical Trial Registries

Many thanks for the response. My area of interest mainly focuses on the modules to work out when doing with study design to conduct a trial. what can be the topics for study design in conducting a trial?

Thank You Emmanuel & agoOnengiyeofori .

Many scientific studies have been conducted on herbs. Traditionally, herbs are the oldest forms of medicine. They have been used for millennia--and very successfully. There are, of course, some herbs that are harmful, but these are known and catalogued. I used herbs clinically without any harmful effects for 46 years (since 1972). There are many good sources and resources to learn about the beneficial effects of herbs, among them www.greenmedinfo.com and www.naturalnews.com.

A good number of Taylor & Francis, Sage and Elsevier journals do not require article processing charge , unless you prefer to publish your work in their open access platforms. Check the website of the journal you wish to publish your work in. You sould be able to find information relating to the requirements for article submission. Alternatively, you may want to consider publishing your work in some credible open access journals. Check the following Directory of Open Access Journals: https://doaj.org/, and search for the journals that are relevant to your research area.

original items would be better. Review articles take time, and they repeat/summarize what was done previously. In my opinion, you'd be better off investing your time toward an original item that contributes new knowledge to the field.

Pharmaceutical promotional activities take many forms, including provision of samples, face‐to‐face meetings between industry representatives and prescribers, advertising in print and electronic media, and support for meetings and travel. There are a number of studies which report that the amount spent by pharmaceutical companies on promotional activities exceeds the amount spent on research and development of new drugs.

See, for example, a free-access paper by Komesaroff PA: “Ethical issues associated with gifts provided to physicians by the pharmaceutical industry” (available at doi:10.1111/j.1445-5994.2010.02215.x) published in the Internal Medicine Journal in 2010. It is a useful source of information on the influence that pharmaceutical companies have on clinicians. The author argues that “The concern is not merely that the evidence shows that all promotional activities influence prescribing behaviour (contrary to the protestations of many physicians) .… What is [also] of concern is the possible impact of this influence on both the form and content of healthcare delivery.” The paper also has many useful references.

One of these references, a pay-to-view paper by Wazana A: “Physicians and the pharmaceutical industry: Is a gift ever just a gift?” published in JAMA in 2000 (available at doi:10.1001/jama.283.3.373), the author notes that: “Meetings with pharmaceutical representatives were associated with requests by physicians for adding the drugs to the hospital formulary and changes in prescribing practice. Drug company–sponsored continuing medical education (CME) preferentially highlighted the sponsor's drug(s) compared with other CME programs. Attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor's medication. Attending presentations given by pharmaceutical representative speakers was also associated with nonrational prescribing.”

A pay-to-view paper by Greenway T & Ross JR published in The BMJ in 2017, titled “US drug marketing: how does promotion correspond with health value” (available at doi.org/10.1136/bmj.j1855) assesses the effectiveness, usefulness, and affordability of the drugs that get the heaviest promotion. This article also has useful references.

A free-access article by De Ferrari A, Gentille C et al., published in PLoS in 2014, titled “Attitudes and Relationship between Physicians and the Pharmaceutical Industry in a Public General Hospital in Lima, Peru” (available at doi: 10.1371/journal.pone.0100114) presents a study described as being in a undertaken in a resource-poor setting, “where a close relationship between physicians and industry still exists”.

This De Ferrari et al. paper also summarises a number of earlier studies as follows: The interaction between physicians and the pharmaceutical representatives adversely influences doctors’ behaviour and knowledge. There is a tendency for non-rational prescribing, more favourable attitudes towards industry representatives, preference for newer, more expensive drugs and an inability to identify incorrect claims about medications. Moreover, this effect on doctors’ behaviour and knowledge is dose-dependent: frequent contacts and acceptance of gifts (independent of the gift's value) imposes a need to reciprocate that affects medical judgment.

Dear Mirac,

using webcam-based eye-tracking you obviously have to make a tradeoff compared to lab-based recordings in terms of accuracy. However, the fact that most laptops nowadays have an integrated webcam, can make this type of data recording cheap and easy to achieve

Since completing my PhD in Cognitive Science last year, I am working on the Labvanced platform (https://www.labvanced.com). Recently, we integrated the webgazer.js library (https://webgazer.cs.brown.edu/ into our event system. Using this, you get an eyeposition every few milliseconds, and hence can calcualte ''total fixation duration'' and ''area of interest'' etc. in a post hoc analysis. We also extend the functionality of webgazer in a way that with the Labvanced Event System you can use fixations on any object (i.e. fixation cross) as a trigger to control the experiment (e.g. go to the next frame). Find an example webcam-based eye-tracking study here: https://www.labvanced.com/player.html?id=2909

Last but not least I can say from our experience it is important to have a good webcam, good lightning conditions, make only few head movements, as well as make calibrations between trials.

Hi Saroj,

Essentially, there are two main ways of getting a sample size for any study.

1. Based on prior similar or closely related studies

2. Based on known, specific and relevant parameters in the population under study.

For the former you need to review your literature, for the latter, a combination of literature review and online tools such as epi calculators may be helpful.

Are you talking about Primary Progressive Aphasia? I work with post-stroke and post-TBI aphasia, so I'm not that familiar with PPA. There is a center at Northwestern that might be able to give you more help. http://www.brain.northwestern.edu/dementia/ppa/index.html

Also, have you tried searching on clinicaltrials.gov?

A lot of research is being done using transcranial direct current and magnetic stimulation (tDCS and rTMS, respectively) as an adjuvant to speech therapy, so you might want to look for those too.

Best wishes,

Rosalind

Jerry Miller's advice is spot-on! And thanks Jerry for the Gopal Kanji book recommendation. But I must disagree (in part) with Mohammed Yousif Abbas Mohammed - rather use an experienced researcher in your own field than a professional statistician, unless they are familiar with your field. Too often, pure statisticians will take a purist line that ties the beginner in knots. You need someone who knows what will be accepted in the field in question, and what will be publishable.

To the best of my knowledge there are not too many of such in West Africa.

Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine is one of the most active. We have been at this for the last 70 years. Check out www.mrc.gm

You can also call +2204495442 and ask to speak to the Head of research governance, Dr Jonas Lexow.

You need to identify the hypotheses, power, or beta (usually 0.80), p-value threshold, or alpha (usually 0.05), the statistical method you want to use and hopefully find an approximate effect you want to find (smaller effect needs larger sample). G*power is great and free. Power analysis assumes perfect distributions, so, you can consider increasing the sample size by perhaps 10-20%, to compensate for skewness and outliers in a continuous variable.

You may see the article titled: "Comparison of Electronic Data Capture (EDC) with the Standard Data Capture Method for Clinical Trial Data", that is available at: http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0025348&type=printable

There is an interaction between Mebendazole and Metronidazole. Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. So all the resources ( Product information leaflet, FDA website, Stockley’s interaction) says to avoid concomitant use of mebendazole and metronidazole.

A case control study was conducted in an attempt to identify risk factors associated with an outbreak of Stevens-Johnson syndrome/toxic epidermal necrolysis that occurred amongst Filipino workers in Taiwan. The risk of developing this serious condition was significantly higher in workers who had taken both metronidazole and mebendazole sometime in the preceding 6 weeks (odds ratio of 9.5). In addition, there was an increase in risk with higher doses of metronidazole.However, Stevens-Johnson syndrome/toxic epidermal necrolysis is a serious condition, and therefore, the manufacturer of mebendazole states that the concurrent use of mebendazole and metronidazole should be avoided .