Clinical Trials - Science topic

I believe that there truly aren't any studies or literature specifically related to the Adult Attachment Interview (AAI) regarding the optimal time interval for administration after an intervention. However, there are other interviews and assessments used in attachment research that might be relevant to this inquiry. For instance, the "Attachment Q-Sort" is a measure of attachment in both children and adults, and studies have explored the best time intervals for administering this assessment post-intervention. While these assessments are not identical to the AAI, they might provide insights into how researchers determine the ideal time gap for conducting attachment assessments following an intervention.

Hi Manjusha Ramesh Ahire

There was a similar question posted on this platform. Please refer to the link below.

Best.

hi,

Follow this link for a better understanding on this concept:

i don't think that is feasible... regulations would not allow it..

What Prof. Jose is taking about is the topic of my other research " The Matrix defense" I would like to share my PPT for your kind reference.

Ma'Mon Abu Hammad, I noticed that in another thread (https://www.researchgate.net/post/MANCOVA-some_assumptions_not_met_Where_next) you stated explicitly that your response was generated by ChatGPT. Thank you for doing that. The response you posted above looks (to me, at least) like it was also generated via ChatGPT. If so, please label it as such (as you did in that other thread). Thanks for considering.

It depends somewhat on the nature of the proof, that is to say which question requires an answer. For example an antibiotic can be shown to work in a Petri dish in the lab before any trials are needed. Usually the question is of the nature: "Does it stop or reverse a pathological process?", in which case a trial in patients is necessary. Then the first study in patients is usually designed to answer it, so it is at Phase 2a.

Unless the compound is toxic, 2a is preceded by Phase 1 in volunteers when its pharmacokinetics and tolerability are checked because that finds the optimal dose to use in 2a. Sometimes volunteers can act as proof of principle subjects and I invented models to do exactly that. For example, using an increasing laser to generate heat on the skin, the volunteer stopping the laser as soon as a pain threshold occurs. It showed that a liquid formulation of paracetamol has a faster onset of pain relief than a tablet. The difference was small, so the precision of the model was essential for detecting the difference and so providing proof of principle. I invented a gastric monitor to study prokinetics in volunteers because again, the precision of the model, made a POP study much easier to design and conduct.

Phase 2a is usually followed by 2b to explore the best dose over a period of time, and possibly secondary indications. Phase 3 is basically designed to assess how well it works in real practice and the incidence and severity of side effects.

I hope that helps the reason why you asked the question.

Manjusha Ramesh Ahire

A Proof of Concept (POC) study is an early-stage clinical trial that aims to demonstrate the feasibility, therapeutic potential, or biological activity of a drug, often in a small number of subjects. It provides preliminary evidence that the drug can have the desired effect in humans before advancing to larger, more costly studies. For generic drugs, POC is typically not required since they are based on already approved drugs with established efficacy and safety profiles. However, for investigational new drugs, POC is crucial to determine if the drug works as intended and is safe. The POC study is an integral part of the drug development process, bridging the gap between preclinical studies and larger-scale clinical trials. For further reading, consider referring to "Principles of Clinical Pharmacology" by Atkinson et al. and the FDA's "Guidance for Industry: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND."

so think of dose titration as a bit like when you're trying to find the perfect setting on your thermostat. You start with a lower temperature and gradually turn it up until your room feels just right – not too hot, not too cold. Dose titration in a clinical trial is kind of like that. Doctors start with a lower dose of a medication and then slowly increase it based on how the patient responds. The goal is to find the lowest dose that does the job without causing too many side effects.

Now, dose escalation is a bit different. It's like climbing a ladder, one step at a time. Imagine you're testing a new medicine, and you want to figure out how much of it people can take before it starts causing problems. So, you start with a small group of participants and give them a certain dose. If they handle it well, you move up to the next dose level with another group. You keep going up until you start seeing some side effects that are too intense or risky. That highest dose where things start getting tricky is called the "maximum tolerated dose."

So, to sum it up, dose titration is like adjusting your thermostat to get the perfect temperature, while dose escalation is more like climbing a ladder to find out how much of a new medicine people can handle safely. Both methods help scientists figure out the best way to use a new treatment and make sure it's effective and safe for everyone.

In clinical trials, generating queries and resolving data discrepancies is typically the responsibility of the data management team. The data management team is a critical part of the clinical trial process and is often composed of individuals with expertise in clinical data management, database programming, and regulatory requirements.

During a clinical trial, data is collected from various sources, such as electronic case report forms (eCRFs) completed by investigators, laboratory results, and other clinical assessments. The data management team reviews the incoming data to identify any inconsistencies, errors, or missing information. If they discover any discrepancies or issues in the data, they generate queries to request clarification or additional information from the investigators or study sites.

These queries are then communicated back to the sites or investigators through a formal process, typically through a data clarification form (DCF) or electronic means, to ensure that the data is accurate, complete, and compliant with the trial protocol and regulatory requirements.

Overall, the data management team plays a crucial role in maintaining the integrity of the clinical trial data, and generating and resolving queries is an essential aspect of their responsibilities.

Because older adults are under-represented in clinical trials, doctors can’t be certain that approved cancer drugs will work as intended in this age group. In the absence of high-quality evidence, researchers are looking for ways to improve medical decision-making and better predict outcomes based on age...

Thank you.

Dekkers (2010) has this very nice paper on external validity in IJE: - it gives you a good overview on the (qualitative) aspects of external validity of clinical trials.

If you want to "measure" the changes of treatment effect when applying trial results into another population, you might want to look at "transportability", a new rising topic in causal inference. See Westreich (2017, AJE) for a brief introduction: and Inoue (2022): for an example of applying transportability.

Dear colleague, check if the STRICTA tool (Standards for Reporting Interventions in Clinical Trials of Acupuncture) offers some guidance.

Good suggestion to cut the cost of medicine produced by famous pharmaceuticals. The patent rights should be finshed after a period of 3-5 years and doctors should write generic medicine instead of expensive brands.

I can't speak for other drugs listed above but for phenobarbital, the drug was before FDA began their review on safety and effectiveness. After that, it seems there were better medication options for seizure. However in 2022, Sezaby (phenobarbital sodium) is a barbiturate was approved by FDA indicated for the treatment of neonatal seizures

Thank you all

Depending on your purpose, you could put it on clinicaltrials.gov.

Hi,

Here are a few references:

Albogami S, Alnefaie A. Role of Amygdalin in Blocking DNA Replication in Breast Cancer In Vitro. Curr Pharm Biotechnol. 2021;22(12):1612-1627. doi: 10.2174/1389201022666210203123803

Cecarini V, Selmi S, Cuccioloni M, Gong C, Bonfili L, Zheng Y, Cortese M, Angeletti M, Kilani S, Eleuteri AM. Targeting Proteolysis with Cyanogenic Glycoside Amygdalin Induces Apoptosis in Breast Cancer Cells. Molecules. 2022 Nov 5;27(21):7591. doi: 10.3390/molecules27217591

Lee HM, Moon A. Amygdalin Regulates Apoptosis and Adhesion in Hs578T Triple-Negative Breast Cancer Cells. Biomol Ther (Seoul). 2016 Jan;24(1):62-6. doi: 10.4062/biomolther.2015.172

Christodoulou P, Boutsikos P, Neophytou CM, Kyriakou TC, Christodoulou MI, Papageorgis P, Stephanou A, Patrikios I. Amygdalin as a chemoprotective agent in co-treatment with cisplatin. Front Pharmacol. 2022 Sep 20;13:1013692. doi: 10.3389/fphar.2022.1013692

You can use Stoll's method even though it can't be best or you can count directly on a glass slide

One option that the Cochrane group supports using is the CASP Qualitative Research checklist: https://casp-uk.net/images/checklist/documents/CASP-Qualitative-Studies-Checklist/CASP-Qualitative-Checklist-2018_fillable_form.pdf

Another useful resource is Section 21.8 "Assessing methodological strengths and limitations of qualitative studies" from the Cochrane group: https://training.cochrane.org/handbook/current/chapter-21

Hi all,

Adverse events need to be recorded using a safety database (e.g. Argus, safety easy ...) and in a clinical trial setting in the trial database. AEs or SAEs need to be reported to the regulatory authority and to the ethics committee.

The response to the question is different if you are Sponsor, clinical trial centre or CRO.

If you are a member of a sponsor or a CRO, Pharmacovigilance is quite a large domain and I recommend you attend to pharmacovigilance (PV)training.

Here is the link to the PV good practices: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices

Quite a lot of materials to read and master.

Hi Esraa,

adding case reports, in absence of controlled trials , is good, as long as you acknowledge the fact the it has several limitations.

if you have data from placebo controlled studies in the same indication, than better you do not use case studies. As case studies are usually considered as weak evidence. Rayer, clinician and patients are biased in this situation.

This article should be helpful:

Antibiotic Approvals in the Last Decade: Are We Keeping Up With Resistance?

with few exceptions, the use of placebo groups as a control will be coupled with the investigators and the patients blinded, to control bias.

the safety data collected in the placebo arm are very important. It helps to make the different between the “expectation bias” and other safety events that are reportes in both groups (like often fatigue …) and the ones that are more frequently present in the active arm.

A searchable database of Pfizer mRNA trial data is available

Hi,

The whole trial is Ethically unviable, so the rest of the questions do not arise.

"..giving children with suspected cutaneous leishmaniasis (a parasitic infection).."

This would be tantamount to a criminal act of causing harm to an individual

Follow these Ethical Guidelines:

Mainly the ethical principles, ae beneficence, nonmaleficence, autonomy, and justice.

The CTRI registration is done after EC approval. Since CTRI does not validate the scientific method, they do have that mandate. It is EC who is a gate keeper of science and ethics of the research.

I was told that a research protocol was being accepted by the BMJ Open, but there is an APC for publishing.

Hi Gelareh,

I encountered a similar problem in one of my studies. The solution to this is to use NIH tool for quality assessment. If you google this, you will find not only a tool for uncontrolled before after studies but also tools for other types of studies as well on the same site. This is an acceptable tool since I found studies in high impact factor journals like JAMA that had used this tool. Hope this answers your question.

Dear Mohammad Ali ,

I found the following title:

-Contemporary Clinical Trials https://www.sciencedirect.com/journal/contemporary-clinical-trials

You might have a look at some of the journals published by Future Medicine as well, they seem to publish Clinical trial studies as well, see for more details here https://www.futuremedicine.com/authorguide/preparingyourarticle some titles are subscription based (so for free), scroll down for some titles suggestions here https://www.futuremedicine.com/authorguide/openaccess .

Best regards.

Hi,

To be honest, in the case of the pharmaceutical industry work practice is that it depends on many different topics:

This is why regulators state that in phase one 12-80 subjects could be involved but its range is optimized within the interaction with Health Authorities (FDA, EMA, national authorities) within scientific advice meetings for example after the presentation of specific documentation like Briefing Books. This kind of approach makes possible case-by-case analysis and precise justification of the range of the study and sample size optimization. Of course, it's an industrial perspective and common practice. So in practice, there is no simple answer but rather some kind of approach with stepwise justification. The reference below could be more helpful,

Ref.

Tomasz

Hi,

Here is a link from Google:

Hello,

This may be a helpful source of e-learning

Regards,

Alphonce Nsabi Simbila

I think a good metric to judge the performance of a diagnostic tool is the false-classification rate. You can detemine the sample size to provide a desired precision of the estimate of this false-classification rate.

Bhogaraju Anand Thank you for your input Dr. Anad, I appreciate it.

interested

Hi,

Maybe some of these references are of help to you:

Economic Evaluation in Clinical Trials By Henry A. Glick, Jalpa A. Doshi, Seema S. Sonnad, Daniel Polsky 2014 | 272 Pages | ISBN: 0199685029

Economic Evaluation of Cancer Drugs: Using Clinical Trial and Real-World Data by Iftekhar Khan, Ralph Crott, et al. English | 2019 | ISBN: 1498761305 | 442 pages

Design & analysis of clinical trials for economic evaluation & reimbursement: an applied approach using SAS & STATA

Iftekhar Khan

Series: Chapman & Hall/CRC biostatistics series

Publisher: CRC Press, Year: 2015

ISBN: 978-1-4665-0548-3,1466505486

Michael F. Drummond, Mark J. Sculpher, Karl Claxton, Greg L. Stoddart, George W. Torrance,ISBN: 0199665877 | 2015 | 461 pages |

https://clinicaltrials.gov/ct2/show/NCT05030779

Study done with CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients with Refractory Systemic Lupus Erythematosus

Hi, David Horton . The Adult AIDS Clinical Trials Group, which has contributed a lot to the global effort to control the AIDS pandemic, has been receiving substantial public funding since its inception that I find it unlikely for it to withhold its tools through strict permission and/or purchase/licensing schemes. Nevertheless, you can directly ask them for such concerns in this link: https://actgnetwork.org/contact/.

Mutasem Z. Bani-Fwaz Good question

Please have look on our(Eminent Biosciences (EMBS)) collaborations.. and let me know if interested to associate with us

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You can modify the PICO model into PECO model (E stands for exposure) while developing your research question for observational cohort design. Here C is considered as the 'unexposed' group. For example, we want to check whether 'attending a health education session on HPV vaccination' is linked to the 'outcome (eg correct knowledge about need and timing of HPV vaccination)' among a 'population of mothers of 8 year old girls'. Here we use PECO in following manner to develop our research question:

P - mothers of 8 year old girls

E - 'attending a health education session on HPV vaccination'

C - not attending this health education session (though invited)

O - correct knowledge about need and timing of HPV vaccination (captured by using a HPV vaccination knowledge scale)

Research Question: Does attendance in a health education session on HPV vaccination improve the correct knowledge about need and timing of HPV vaccination among mothers of 8 year old girls (as compared to not attending this health education session)?

If surveys provide binary answers (yes/no), you can perform a meta-analysis of single proportions using the inverse variance method (with Freeman–Tukey double-arcsine transformation) or a generalized linear mixed model. It is easy to implement in Stata or R, eg. with Metaprop.

Hi Nirmal, How are you getting on with this systematic review? Did you include case studies and case control studies?

I can imagine there would be quite a mixture of literature types on your topic.

This may be helpful.

Sometimes, the prices you look up on google can be misleading. Contacting an expert in the specific field who has successfully received grants in your field would be helpful to rebudget the grant.

It is better to discuss with a statistician regarding the required sample size before starting the research study. It depends on a lot of factors and one of the important factors is the variance between the two experimental procedures. G power is a good software to calculate the sample size. I have attached a reference below.

Hi,

Clinical trials form one of their agendas but they are lot many things which are also priorities. I don't think that anywhere a single-window system exists. clinical trials are of diverse nature and permissions have to be obtained from several departments.

It is a good idea to register the trail before the enrollment of participants in the study. International Committee of Medical Journal Editors and various other reputed journals require the trial to be registered prior to publication.

Creo q si son confiables y la esperanza del mundo para vencer la Covid 19.

Excellent source!! Thank you very much!

Thanks to Proloy, Robert and Vasileios for your answers!

Yes, now I understand what you actually meant Khaled M.E Elawdan . I fully agree with Tomasz Grabowski especially the paragraph below.

Another difficulty is the complex nature of the disease. The more complex target disease in its etiopathogenesis in humans, the more difficult it is to verify a drug candidate in the preclinical phase. Moreover, the etiology of many diseases is not exactly known, therefore many drugs are only symptomatic drugs. The symptoms-effects observed in the models may not be properly selected in the preclinical phase and generate an error. After all, there are many examples of drugs discovered by accident or drugs which, depending on the dose level, have different mechanisms of action. All of this can lead to the situation you are writing about.

Tomasz Grabowski as you mentioned it is going to be risky.

Thank you Khaled M.E Elawdan for a good question.

Best Wishes.

Daniel thank you for you answer! Indeed, it seems this software can produce R code that might accommodate my design. I'll look more closely into it!

Thanks,

-Lasse

IN MULTICENTRIC TRIAL IT IS ADVISABLE THAT IT SHOULD HAVE CENTRAL LAB WITH ACCREDATION HOWEVER IF IT IS NOT PRACTICALLY FEASIBLE ONE CAN HAVE DIFFERENT ACCREDATED LAB WITH SAME METHODOLOGY WHICH IS ACCEPTED BY REGULATORY AUTHORITY. THIS IS DONE FOR UNIFORM DATA WHICH IS GLOBALLY ACCEPTABLE AS PER ICH-GCP

Unfortunately this was withdrawn.

Therefore, at present, as far as I know, there are no clinical trials for this possible treatment.

Please see papers on this topic below:

Oxytocin and COVID-19 papers:

Cardiovascular protective properties of oxytocin against COVID-19

Stephani C. Wanga and Yu-Feng Wang

Life Sci. 2021 Jan 26 : 119130.

doi: 10.1016/j.lfs.2021.119130

https://www.sciencedirect.com/science/article/pii/S0024320521001156

Oxytocin May be Superior to Gliptins as a Potential Treatment for Diabetic COVID-19 Patients

Phuoc-Tan Diep

SciMedicine Journal

Doi: 10.28991/SciMedJ-2020-02-SI-10

https://scimedjournal.org/index.php/SMJ/article/view/181

Is there an underlying link between COVID-19, ACE2, oxytocin and vitamin D?

Diep P

Medical Hypotheses (2020) 110360

https://doi.org/10.1016/j.mehy.2020.110360

Hypothesis: Oxytocin is a direct COVID-19 antiviral

Phuoc-Tan Diep, Khojasta Talash, Violet Kasabri

Medical Hypotheses 145, 110329, 2020

https://doi.org/10.1016/j.mehy.2020.110329

Oxytocin as a Potential Adjuvant against COVID-19 Infection

Pratibha Thakur, Renu Shrivastava and Vinoy Kumar Shrivastava,

Endocrine, Metabolic & Immune Disorders - Drug Targets (2020) 20: 1. https://doi.org/10.2174/1871530320666200910114259

Can intravenous oxytocin infusion counteract hyperinflammation in COVID-19 infected patients?

Benjamin Buemann, Donatella Marazziti and Kerstin Uvnäs-Moberg

https://www.tandfonline.com/doi/abs/10.1080/15622975.2020.1814408?journalCode=iwbp20

Oxytocin's Anti-inflammatory and Pro-immune functions in COVID-19: A Transcriptomic Signature Based Approach

Ali S. Imami et al.

https://journals.physiology.org/doi/abs/10.1152/physiolgenomics.00095.2020

Brain oxytocin: how puzzle stones from animal studies translate into psychiatry.

Grinevich, V., Neumann, I.D. Mol Psychiatry (2020). https://doi.org/10.1038/s41380-020-0802-9

Oxytocin as a potential defence against Covid-19?

Amélie Soumier and Angela Sirigu

https://www.sciencedirect.com/science/article/pii/S0306987720306800?via%3Dihub

Oxytocin, a possible treatment for COVID-19? Everything to gain, nothing to lose

Phuoc Tan Diep, Benjamin Buemann, Kerstin Uvnäs-Moberg

Hi,

Since there is no intervention or control and only observation, it is a cohort observational study.

Is this a phase IV, surveillance study?

STANDERD VALIDATED MODEL AVAILABLE, PLEASE REFER TO ONE OF OUR PUBLICATION IN VIROLOGICA SINICA:

doi: 10.1007/s12250-020-00252-z. Epub 2020 Jun 30.. 2020 Jun;35(3):290-304.Virol Sin

A Comprehensive Review of Animal Models for Coronaviruses: SARS-CoV-2, SARS-CoV, and MERS-CoV

Ashutosh Singh 1, Rahul Soloman Singh 1, Phulen Sarma 1, Gitika Batra 1, Rupa Joshi 1, Hardeep Kaur 1, Amit Raj Sharma 1, Ajay Prakash 1, Bikash Medhi 2

Have a look at this useful RG link.

Hi,

Here is a reference for the topic: the 2nd ref. has more details

Kolahi, J., Bang, H., & Park, J. (2009). Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community dentistry and oral epidemiology, 37(6), 477–484. https://doi.org/10.1111/j.1600-0528.2009.00494.x

Assessing Blinding in Randomized Clinical Trials

https://scholarworks.calstate.edu › downloads

Hi,

Some of these articles or links can give you detailed information;

ANNEX 1 WHO GUIDELINES ON CLINICAL EVALUATION OF.VACCINES..

http://www.who.int › biologicals › publications

Estimation of Treatment Effect with Missing Observations for Three Arms and Three Periods Crossover Clinical Trials

Isoken Odia please have a look at this i feel this might be of your interest

In my opinion, the underlying cause is the pressure to publish more because of various reasons well known to the people related to academia. Dishonesty and misconduct can be minimized by inculcating research ethics during early period of professional education of young researchers. Educating students about what actually constitutes misconduct is also important because at times many researchers do not even realize that their practices are unethical.

For clinical trials (preferably RCTs), the gold standard is the Risk of Bias (ROB) tool of Cochrane collaboration. Currently, ROB 2 is available. For non-randomized trials, the ROBINS I (Risk Of Bias In Non-randomised Studies - of Interventions) is better. Please find the following links:

It will depend on the sponsor of the trial and the country legislation. Many countries it is not required by law. In this case companies might follow ethical guidelines like CIOMS . If it is required by law and the law does not legislate timelines, then its up to the company. Usually after the trial has finished and the data is digitalised.

Please have a look at these useful links.

You would have to go very far back, I think, to the era before systematic reviews, and even there the problem was more generalisation of RCT findings to groups that hadn't been included in the trial, such as the use of beta-blockers for hypertension in older patients.

The only case I can think of where there were positive results, but the underlying rationale was later discredited was the Paris streetscape. After the cholera epidemic in (?) 1832, they demolished slums, widened streets and installed sewers to reduce exposure to 'miasma' (foul air, believed to cause cholera). It worked, but not for the reasons they thought.

Hello Mohammad

Explanatory trials focuses on evaluating the efficacy of an intervention in a controlled manner so that the errors or biases could affect the results to a minimum. This will result in trials with high degree of internal validity that will provide answers to the questions related to the environment and patient group. It focuses on measurable symptoms or markers which are much easier to evaluate. So in short, explanatory trial puts forth an ideal condition in which an intervention works. Therefore, they are more preferred by the funding agency.

On the other hand, pragmatic clinical trial is designed to test the effectiveness of an intervention in a routine clinical practice. It is less controlled and difficult to judge how the intervention worked. This type of trial takes into account the full spectrum of everyday clinical setting in order to maximize applicability. So it lacks support.

There is a need to shift towards pragmatic trials because it gives a more realistic view.

Regards.

ICER is used when you have a new costly/more effective intervention and you want to access its economic burden as compared to an alternative standard of care. This may not be your case, as the educational intervention can save resources. So, you should obtain the net cost saving instead. The sample size for micro-costing usually depends on qualitative assessment. You will find more on these subjects at:

CEA studies: https://www.cdc.gov/policy/polaris/economics/cost-effectiveness.html

Micro-costing: https://core.ac.uk/download/pdf/18510449.pdf