Questions related to Clinical Trials
We are considering using the Adult Attachment Interview (AAI) as a treatment outcome measure for a short clinical trial we are conducting. However, we are concerned that using the AAI directly following intervention (approximately 4 weeks pre-> post), would be too soon to measure shifts in attachment categorisation. Does anyone have any recommendations and/or literature that may advise appropriate recommended time points between AAI administration for valid results post-intervention?
Many thanks for your wise support!
Raw data is now rarely presented in clinical trials on nutrition. Most of the time I see data that has been "adjusted" for one or more variables. I do not remember seeing any explanation as to the technical details of these adjustments.
How exactly is this adjustment occurring? What is the math? And why was that math developed? What are the underlying assumptions behind it?
My concern is that we may be adjusting away important correlations if some of our adjustment assumptions are incorrect.
Can someone please help me with this?
Engaging in illegal activities such as involving students in potentially illegal clinical trials is unethical and against the law. Clinical trials are conducted to test the safety and efficacy of new drugs or medical treatments before they can be approved for public use. These trials must adhere to strict ethical guidelines and regulations to ensure the safety and well-being of participants.
Pharmaceutical companies and pharmacy colleges are typically expected to adhere to ethical standards and follow legal regulations when conducting clinical trials or collaborating on any research. Involving students in clinical trials without proper consent, adherence to ethical standards, and oversight can lead to serious legal and ethical consequences.
Universities and colleges generally have Institutional Review Boards (IRBs) or Ethics Committees that oversee research involving human participants, including clinical trials. These bodies ensure that research is conducted in an ethical manner and that participants' rights and safety are protected. Students and researchers involved in clinical trials must follow these guidelines and obtain proper approvals before conducting any research involving human participants.
If you suspect any unethical or illegal activities related to clinical trials, it's important to report them to the appropriate authorities, such as your institution's IRB, regulatory agencies, or legal authorities, as applicable in your jurisdiction.
Raising awareness among students about the potential dangers of participating in unregulated clinical trials is essential to ensure their safety and well-being.
Here are some steps you can take to raise awareness:
- Educational Workshops and Seminars: Organize workshops, seminars, or guest lectures featuring experts in clinical research, bioethics, and patient safety. These events can provide students with valuable insights into the importance of regulated clinical trials and the potential risks of unregulated trials.
- Collaboration with Faculty: Work closely with faculty members in pharmacy and medical departments to incorporate discussions on clinical trial ethics and safety into the curriculum. This can help integrate the topic into the academic experience of students.
- Informational Campaigns: Launch awareness campaigns through posters, brochures, and digital platforms to provide information about the risks of unregulated trials. Make sure to use language that is accessible to students and clearly explains the potential dangers.
- Guest Speakers: Invite individuals who have been affected by unethical or unregulated clinical trials to share their stories with students. Personal narratives can be powerful tools for conveying the potential consequences of participating in such trials.
- Online Resources: Develop online resources, such as articles, videos, and infographics, that explain the differences between regulated and unregulated clinical trials. These resources can be easily shared and accessed by students.
- Ethical Dilemma Discussions: Organize discussion sessions or debates on ethical dilemmas related to clinical trials. This can encourage critical thinking and help students understand the complexities of the issue.
- Partnerships with Ethical Organizations: Collaborate with organizations that promote ethical clinical research and patient safety. They might offer resources, speakers, or materials that can enhance your awareness efforts.
- Case Studies: Present real-life case studies that illustrate the negative consequences of participating in unregulated trials. Analyzing these cases can help students understand the potential risks and make informed decisions.
- Engage Student Organizations: Involve student organizations, such as pharmacy clubs or medical associations, in spreading awareness. They can organize events, workshops, or information sessions tailored to the interests of their peers.
- Social Media Campaigns: Utilize social media platforms to share facts, statistics, stories, and infographics about the dangers of unregulated clinical trials. Engage with students through interactive posts and discussions.
- Guest Experts: Invite experts in the field of clinical research, regulatory compliance, and bioethics to speak to students. Their expertise can provide valuable insights and answer students' questions.
- Networking Opportunities: Provide students with opportunities to interact with professionals working in regulated clinical research. Networking can offer firsthand knowledge and dispel misconceptions about the industry.
By combining these strategies, you can create a comprehensive awareness campaign that educates students about the potential dangers of participating in unregulated clinical trials and empowers them to make informed decisions regarding their participation in research studies.
I have performed a double-blind, placebo-controlled, randomized clinical trial with N=63 (32 in the placebo group and 31 in the intervention group). After submitting my manuscript, I received major revisions. In one of the comments, the reviewer asked me to justify the sample size. The reviewer's comment was: "Sample size justification required proper drafting"
I do not know how to justify the sample size of my research
Sample size calculation
For the calculation of sample size, the significance level and statistical power were considered as 5% and 80%, respectively. According to the study of Mesri Alamdari N and colleagues, we used 0.23 nmol/L as the change in mean (d) and 0.29 nmol/L as the standard deviation of MDA as a primary outcome. Based on the formula, we needed a minimum number of 25 participants for each group. Considering the dropout rate of 20% during the clinical trial, 30 subjects in each group will be considered.
Thanks in advance
I am at loggerheads with a sponsor of a clinical trial that is declaring that they have no responsibility for identifying queries that need to be resolved at clinical trial sites within a multi site trials.
I would argue there is a scientific and ethical imperative for clinical trial sponsors to generate queries.
Can anybody provide substantiation for my opinion?
This generalizable immunotherapy approach to cancer seems compelling:
Unlike many other immunotherapies, this one does not require pre-defining antigens.
Based on research from the Levy lab at Stanford, this method introduces a non-specific technique to attack cancers by injecting immunoenhancing agents (TLR9 and OX40) locally into the tumor site. In mouse models, these agents activated a robust, targeted anti-tumoral response.
Clinical trials were launched in 2019/2020.
What's the best way to track the clinical trials and see how this therapy work on humans?
Greetings fellow researchers,
I am embarking on a meta-analysis project to study the efficacy of a certain drug, let's call it "Drug A". My challenge lies in the limited and varied nature of the clinical trials available. So far, I have identified only three clinical trials conducted on Drug A. Two of these trials are double arm (comparing Drug A against a placebo), while one is a single arm trial.
I am grappling with how to best proceed with the analysis given the different study designs. I would like to harness as much data as possible from these trials to ensure my meta-analysis is robust. One approach I am considering is to extract single arm data from all three trials and analyze this, but I'm unsure if this approach is methodologically sound or if it introduces biases.
Does anyone have advice on whether this is an appropriate approach or if there are alternative strategies I should consider? Could I potentially combine the single-arm and two-arm trials in some way? And if so, what statistical methods or adjustments should I be aware of to correctly handle the different types of data?
Any insights or guidance would be highly appreciated.
Dr. Moiz Ahmed
External validity is the extent to which we can generalize the findings of a study to other situations, people, settings, and measures.External validity can be increased by using broad inclusion criteria that result in a study population that more closely resembles real-life patients, and, in the case of clinical trials, by choosing interventions that are feasible to apply.
In designing a clinical trial, it is necessary to consider a false pressure point for sham groups. Given that the main pressure point is around the lumbocostal region, what specific point or points are suggested for this purpose?
A lot of people complain about expensive drugs, and the drug companies tell you that the reason for this is "the cost of development" and in particular "clinical trials". Before I tell you my idea, I must tell you that I am not a doctor and a complete amateur in every sense.
Now, to my idea. At the same time as we have expensive drugs people complain about power structures in academia, large publication gateways and huge tuition fees that prevent access to research and knowledge.
What if these two factors were seen as one problem? You widen the entrance at the same time as you drastically increase the subsidies for clinical trials, thus relieving drug companies of their alibi. When I say widen the entrance, I mean compulsory open access publication for certain types of projects and public domain and creative commons patents. So you pay less for research and also for clinical trials.
(If you like my idea, I also have a patent for a perpetual motion machine.)
Many excellent drugs have passed all the necessary clinical trials, and they are approved in their original countries but still not approved by FDA!! Why??
I can mention Phenobarbital which is considered one of WHO Model List of Essential Medicines... Favipiravir already used in Japan; and natural drugs such as Diosmin "already sold under the brand name Daflon", cucrumin, thymoquinone, thymol etc.
I need to publish my protocol on Low Back Pain management clinical trials. Please help me find a journal that publishes papers faster. I would prefer journals from Wiley, SAGE, Walters Kluwer, and Hindawi.
Thanks in advance.
The question is whether clinical trials have been conducted on the use of vitamin B17, also known as amygdalin or laetrile, in metabolic therapy for breast cancer to kill tumor cells. Vitamin B17 is a natural substance found in many plants, particularly in the seeds of the rosaceous fruits such as apricot kernels and other bitter nuts. It has been promoted by some as a potential cancer treatment, with claims that it can kill cancer cells while leaving healthy cells unharmed. Breast cancer is one of the most common types of cancer, affecting millions of people around the world. Treatment options for breast cancer include surgery, radiation therapy, chemotherapy, and hormone therapy. These treatments can be effective in killing cancer cells, but they also come with a range of side effects and are not always successful in completely eliminating the cancer. Metabolic therapy is an alternative approach to cancer treatment that involves using diet and nutrition to boost the body's natural defenses against cancer. Proponents of metabolic therapy claim that it can help to improve the body's immune system and make it better able to fight cancer cells. Vitamin B17 is often used in metabolic therapy as a way to supplement the body's natural defenses and help to kill cancer cells.
I need to observe the fecal egg reduction in rats that I'm studying. I need a protocol how to do it without a McMaster slide.
I have three reports that I want to include in my systematic review. These are all qualitative information of the findings of the original RCT. They only include qualitative data of the intervention group.
Is there any determined system like the FDA-recommended system for finding/documenting the drug side effects of patients in a clinical trial?
Is it better to use published trials that have a similar topic to our project for listing/classifying side effects?
We are working with pathogenic bacteria. From the literature we can access to know molecules with potential antibacterial activity, clinical trials, but we are interested in the already approved antibiotics (wide spectrum, and specific for several pathogens). Do you know a database, or a specific mechanism to ask directly at FDA?
In a phase II clinical trial that assess the safety and tolerability of an investigational product versus placebo, do we normally consider a tolerability rate for the placebo group? Do we expect them to be very compliant and rarely miss does?
Following release of Pfizer mRNA trial data, ordered by a court to be released 75 years ahead of the original plan, we see to 31 March 2021 that 38 participants were Dead, average age 65 years. The injection history of the dead was as shown:
1 x Placebo 2
2 x Placebo 15
1 x Pfizer mRNA 2
2 x Pfizer mRNA 17
2 x Placebo plus 1 x Pfizer mRNA 2
In addition 193 people were "Lost to Follow-up" after multiple attempts to contact them with failure to respond to a certified letter sent to their last known address.
Their injection history was:
1 x Placebo 49
2 x Placebo 51
1 x Pfizer mRNA 45
2 x Pfizer mRNA 48
Has anyone found further publications following the fatality rate among the 44,820 trial participants?
I'm currently writing an essay for a university assignment on whether a, presumably hypothetical, clinical trial is ethically justified. I see that the second of the 4 questions that the National Institutes of Health (NIH) prompts you to answer/think about when defining if a study is a clinical trial is: "Are the participants prospectively assigned* to an intervention**?" (https://grants.nih.gov/ct-decision/index.htm)
The question is then further broken down by explaining that "prospectively assigned" refers to a pre-defined process (e.g. randomisation).
The essay question I have reads as follows: An investigator plans to conduct a clinical trial in remote parts of Brazil and Mexico. The trial involves giving children with suspected cutaneous leishmaniasis (a parasitic infection) a newly developed drug treatment over a 3 week period and then collecting a series of samples from them, including stool samples. What ethical issues does this scenario raise, and are they acceptable?
If a researcher is looking to do a clinical trial on children in the rural parts of Mexico and Brazil, I imagine the sampling method here would come under the non-probability sample method purposive sampling (https://www.scribbr.co.uk/research-methods/sampling/) -- Does this still fit what "prospectively assigned" refers to, even if the subjects for the trial aren't randomly chosen?
Also, I'm guessing that the question Are the participants prospectively assigned to an intervention? in full means to ask, 'Are the participants, that have been selected by a method of sampling, assigned to an intervention treatment for the disease the trial is investigating?'
Sorry that this wasn't written very succinctly, it's my first time asking a question on the website and I've only begun my second year of university, so I'm still coming to understand various terminologies.
How to go with a proposal of a clinical trial received to IEC -
Can Ethics clearance can be given after methodology check provisionally till a valid CTRI
registration number is provided to the ethics committee, along
with a copy of the details of CTRI registration. at CTRI, India
Looking for peer-reviewed journal recommendations that publish clinical trial protocols/methods for behavioral interventions AND do not charge an APC/APF. I have already submitted to Contemporary Clinical Trials (rejected) but am having trouble finding others. Thanks for any help.
which tool would you suggest for assess of RoB of the uncontrolled interventional before-after studies. There are such kinds of clinical trials, in which the participants are checked before employing the intervention as there is no separate control group. They are also checked after applying the intervention.
As ROBINS-I is designed to be used for the controlled studies like nRCTs and NOS is proper for the cohort and case studies (cohort is a non-interventional study (observational)) and unfortunately NIH is not a standard and official tool, which tool would you suggest?
Thanks in Advance, Gelareh
I am looking for a journal that publishes a clinical trial protocol for free. Could you please suggest some medium to high-quality indexed journals? Please do not suggest a predatory one!
How to estimate the minimum number of subjects that should be enrolled for phase 1 of a clinical trial?
The objective of phase 1 is to test for the safety, side effects, dose etc. I know we usually use less subjects compare to phases II and III. But what is the appropriate minimum number of subjects for phase 1? How to estimate this number?
I want to cite a clinical trial from clinicaltrial.gov of incertin mimetic exenatide in spinal cord injury. However i am unable to get the citation of the study. I also tried google Scholar searching the heading of the study but with no success. Please let me know how can I cite this study using endnote
I'm a medical writer, and recently, I've finished a GCP course. I wanted to know more about regulatory documents such as study protocol, investigator brochure, Informed consent, etc. I wanted to know how they are written and have a look at their formats because I'm interested in this field. Can someone guide me on how to find these documents?
I was trying to design a trial comparing one diagnostic tool (which will give 9 different output) to a common gold standard (which also gives the same output catagories). However, I'm so confused about how to estimate sample size for each output (or catagorical group). My first thought was to use specificity and sensitivity to calculate, but it's unlike nomal binary variables.
Should I use the same method for binary variables and use it aginst each catagory (i.e. make the studying catagory as positive and the rest as negative), so we can get a postive group sample size and a negative group (which contains the rest of eight outputs)?
REALLY appreciated if anyone can give me a hint or approach to this.
I am disparately searching any research that can explore clinical trials conducted on GANODERIC ACIDS?
These biologically active constituents basically obtained from mushroom Ganoderma lucidum.
I have two questions and hope for some expert advice please?
1. My understanding is that when conducting an economic evaluation of clinical trial data, no discounting of costs is applied if the follow-up period of the trial was 12 months or less. Is this still the standard practice and can you please provide a recent reference?
2. How can one adjust for uncertainties/biases when you use historic health outcomes data? If the trial was non-randomised, how can you adjust for that within an economic evaluation other than the usual probabilistic sensitivity analysis?
Thank you so much.
Does anyone know of any current clinical trials for this research:
Sequential transcriptional changes dictate safe and effective antigen-specific immunotherapy.
Has this been done with current vaccines and do you have links to the research to provide us with?
Double-blind clinical trials for coronavirus COVID 19.
1. Original research
2. Review article
3. Clinical case study
4. Clinical trial
5. Perspective, opinion, and commentary
6. Book review
we are a small group of pharmacists looking for collaboration and joining a research group in the fields of clinical applications &clinical trials, QC projects related to the pharmacy practice and pharmaceutical industries, extemporaneous preparations, and sterile preparations.
I have a question , as we know that mostly we use PICO model or approach for clinical trials in conducting systematic Literature review, so what model or approach we use in observational cohort studies or case studies, or in qualitative research or any other study design. thank you very much for advance for your kind answer.
The initial use of meta anysis is to compare results from clinical trials.
However, could I use it for data obtained from questionaire.
For instance, the question for dentist would be: ''Do you sterilize your devices regularly?''. I will try to combine responsed from different studies.
Is there any manual or framework on that methodology?
I am planing to write systematic review in rare disease. My inclusion and exclusion criteria meets 35 research articles. However, most of the studies are retrospective and only limited studies have case-control and clinical trials.
Is it appropriate to include these studies together in systematic review (retrospective studies without control)?
When submitting an initial proposal for an IIT, we are asked about preliminary costs of the study. There are some vague guidelines about it but my concern is that quite a few proposals have been rejected due to requested grant not corresponding to "fair market value". How can I find those fair market values or any benchmarks to roughly calculate the cost of our project? What I've learned from googling that there some proprietary databases of clinical trials prices but I think they are pretty pricey.
What is your approach to calculate the budget in IIT?
Suppose we want to demonstrate a new device has improved accuracy than the old device, so we have a training study and clinical trial. The training study is used to develop machine learning algorithms and set cutoffs for the clinical trials. It can also give us an initial estimate of accuracy.
My question is: what is the minimum patient sample size for the training set and the clinical trial? I know we would always prefer more patients, but it is limited by time, cost, infrastructure, etc. Thank you.
To issue a permit for clinical trials, it is necessary to obtain approval from a number of expert bodies - the Commission on Bioethics, the National Medicines Regulator ... often the applicant has to apply separately to these expert bodies.
How necessary and effective are single window mechanisms for authorizing clinical trials?
If a group of researchers have designed a clinical trial and they performed it and got the results and wrote the whole manuscript. However, at the end, they discovered that they didn't register the trial any where!
1. Can it be registered at this point?
2. Can a trial be published if it was not registered?
While BioNTech and Pfizer, as well as Moderna, are leading the race to develop a COVID-19 vaccine, other pharma companies — such as Sanofi, Sinovac and Johnson & Johnson — are expected to soon present candidates of their own.
According to the World Health Organization, 47 vaccines candidates are currently in clinical trials, of which 10 are in phase 3 efficacy trials. Russia has already registered two vaccines, one of which — Sputnik V — became available for public use in August. Experts, however, warn that this vaccine has been insufficiently tested.
Many questions, however, remain unanswered. It is unclear, for instance, how effective these vaccines are, and how they affect individuals of different ages and those with pre-existing medical conditions. Little is known about whether the vaccines lead to long-term immunity, or if they can prevent severe, or indeed asymptomatic COVID-19 infections.
It is also not known how much the vaccines will cost, who will have access to them and in what quantity and at what time, and how they will be distributed around the globe.
Are the vaccines safe?
Independent monitoring groups registered no serious safety concerns with the vaccines being developed by BioNTech/Pfizer and Moderna. This does not, however, rule out the possibility of serious side effects occurring during large-scale testing, or when vaccines are given to persons with rare pre-existing health issues.
Intramuscular injections also bear to the risk of causing local reactions. Moreover, immune responses that entail the production of B cells and supportive T cells can lead to fever, chills, muscle aches or headaches.
In addition, both vaccines — BioNTech/Pfizer's BNT162b2 and Moderna's mRNA-1273 — belong to a new family of vaccines that so far has not been approved for medical use. They contain nucleoside-modified messenger RNA which functions as a blueprint for the virus spike protein. Once administered, the vaccine stimulates the human immune system to produce antibodies against this protein and thus the virus.
Has anyone shared or found clinical trials concerning evaluation of alfapeginterferon 2a and 2b clinical efficacy in HBV treatment?
If you could be as gentle as to leave me some information, it will make me very grateful.
If I can be of any help too, just ask for it!
I am writting a metanalysis, the relation of My exposition and outcome variable is present in Cross sectional, case - control and cohort studies, also in clinical trials. These studies have diferents ways to calculate association measures
As all know, in successful pre clinical cancer experimental studies, only 8% could be successful as well in human studies and clinical trials.
Can you reverse the previous statement, expecting successful data in clinical trials although of failure in pre clinical studies?
I have a a question regarding how to most accurately perform a power calculation for our design. I want to calculate the sample size needed given power/alpha, in a manner that takes into account the fact that we have two levels of clusters (i.e. clusters nested within clusters). Any suggestions for papers, software programs, R packages etc. are welcome!
The study design:
We are planning an evaluation of an intervention delivered to preschool-teachers. The aim of the intervention is to bolster teachers' ability to identify signs of abuse in children, and bring concerns of such maltreatment to the attention of child protective services.
The intervention is an information program comprising three full-day seminars and training, lasting a total of 3-4 months. Preschools (cluster level 1) are randomly assigned to either an intervention or wait-list arm. Preschools in the intervention arm receive the intervention in groups of 50 preschools, i.e. in group format (cluster level 2). We intend to assess outcomes by collecting self-report measures on the teachers pre- and post-intervention (and obviously by comparing outcomes between the two arms).
Groups of 50 preschools (cluster level 2).
Preschools (cluster level 1).
Most power calculations I have seen takes into account only one cluster (the clusters that are being randomized, in our case the preschools). But we have two levels of clusters (preschools and groups), and need to model this in a multilevel analysis which accommodates all levels.
Can anyone point me in the right directions?
Clinical trial data are from different labs, each lab with will have different ranges for the laboratory parameters.
How often we would go for normalisation methods? Or is there any specific scenario when we could go for it?
Below is the reference article for lab range normalisation
I want to investigate the clearance of some medicines on dialysis. These meds are regularly taken by patients and I am going to only control they are taken. Will it be a clinical trial (meds are given) or an observational study (meds are given not by me)?
We our team is in a desparate need to do in vivo studies on SARS COV-2 infected animal model such as hamster and mice, we have an awesome lead on in vitro and first clinical trials for based on our research paper, is there an lab who will do the whole in vivo testing including the total ADMET profile for our sample which we will provide. Please let me know if there is any laboratory who does the studies as mentioned above.
There is growing optimism about Remdesivir, a repurposed drug (tried for hepatitis C and Ebola treatment) to treat COVID-19 patients. The drug is structurally similar to a component of the COVID-19 viral RNA. Therefore, drug is predicted to inhibit the viral multiplication in cells of the patients. Further, the drug is shown to reduce the production of inflammatory proteins by cells. Together, these observations support the notion that Remdesivir could be beneficial in COVID-19 patients. Correspondingly, in a clinical trial, which involved 113 COVID-19 patients, treatment with the drug resulted in a speedy recovery of the patients (and only 2 patients died). However, the clinical trial did not include a control group (patients without the drug). Therefore, additional clinical trials involving the drug are in progress to investigate its usefulness in treating COVID-19 patients.
In Clinical Trials of Vaccines Development, what could be examined in different three trials like I-Phase, II-Phase and III-Phase Trials?.
I would like to understand how to use proc mi for a crossover clinical trial where all subjects receive each drug at different timepoints
Publication and subsequent reliance on false study results would be detrimental for patient care. Unfortunately, research misconduct may originate from many sources. While there is evidence of ongoing research misconduct in all its forms, it is challenging to identify the actual occurrence of research misconduct, which is especially true for misconduct in clinical trials.
Research misconduct may originate from many sources. It is often difficult to detect and little is known regarding the prevalence or underlying causes of research misconduct among biomedical researchers.
Is CASP Critical Appraisal used? and how are the studies evaluated using this checklist?
How hard/easy is it to get access to clinical trials raw data, and how long does it usually take to get access clinical trials individual patient data through websites such as The YODA project or MSD?
I would be most grateful for advice on interesting clinical cases where interventions have been approved based on hypothesis test results from high-quality RCTs, but where it has subsequently been discovered that the hypothesis test results corresponded to false positives. I am particularly interested in cases where, despite the positive RCT finding, the scientific rationale behind the hypothesis was later discredited.
Many thanks in advance!
in academics, explanatory clinical trial is generally conducted to establish a relationship between intervention and outcome. funding agency also supports explanatory clinical trials. whereas the outcome out of a pragmatic clinical trial is more generalizable.
Regarding a clinical trial that evaluate an educational intervention for diabetic patients, 78 patients were enrolled (39 in control and 39 in intervention group)... However, only 60 patients (30 in each group) had completed the study .... So in this case how to measure costs? can someone calculate costs for only those who completed the study? or we must add costs for medications, education and consultation for those who lost in follow up?
Is it normal to get higher costs among control group because they use more medications? can someone measure ICER by measuring the difference between 2 group in regard to difference in costs between start and end of study (for each group) [ delta cost difference of group 1 - delta cost difference of group 2]? if it is OK, can someone provide me with a reference about it
On the other hand, the study was for 6 months of follow up, can I measure QALY according to 6 months values of quality of life? how to solve such problem?