Questions related to Clinical Research
I am doing an clinical research in homoeopathy "Efficacy of Osteo Arthritis nosode in the treatment of osteoarthritis of knee joint" For the same I need guide lines.
I am looking thesis topic in clinical research management. I am planning start an internship at CRO company. Areas of interest- Comparative study or retrospective study; GCP , Adverse events reporting or clinical data management etc. Any suggestions will be helpful
After establishing the appropriate dose, clinicians wish to assess the efficacy and safety of a new intravenous agent in patients with recurrent, platinum-resistant ovarian cancer. The primary endpoint was Response Evaluation Criteria in Solid Tumour (RECIST) overall response rate (ORR). The researchers wish to exclude the uninteresting rate of 10%, with a more desirable response rate of 20%. They decide to use a significance level of 10%.
a) The investigators have asked you to calculate a sample size for this study. Write out an appropriate formula.
b) Using a 10% significance level, how many subjects would be required to exclude a response rate worse than 10%?
I am conducting a systematic review about a newly developed psychological intervention for children, but all studies available are of exploratory/feasibility nature and I am not sure how to evaluate/analyse their results.
I am wondering if anyone is aware of guidelines or articles regarding the decision process of going from a pilot/feasibility stage to full RCT?
I am sure this is a relevant question in many departments, deciding if the results from exploratory studies justify going further with expensive RCTs.
I have been looking in to Cochrane Library etc. to see how they evaluate evidence, but what I can find is mostly regarding making clinical guidelines based on evidence availible (RCTs and other sources of evidence).
If anyone knows anything about this process, guidelines for going from exploratory to RCTs, I would be immensely grateful since I feel a bit stuck on this question (how to analyse the results from feasibility/exploratory intervention studies, what criteria can be used for deciding to go ahead or not with RCTs etc..)
Radiology is a victim of its own success. Marked improvement in coverage and turn-around time, principally achieved through technology, has been met with ever increasing pressure for even improved metrics. Academic departments are sacrificing their defining qualities to improve TAT and faculty surveys, hiring radiologists to work 24/7 in reading rooms that once allowed solo residents to transition to independent practice. At what point does academic medicine stand up for what it believes in? At what point does there cease to be a significant difference between academics and private practice?
How to participate in clinical research after graduation. clinical practice experience is very important in addition to, research skills ... However, after finishing university it is very hard to find a place in research team or be a part of a clinical research. how can I participate in researching teams or international studies.. Especially if I am away from my University?
I am preparing to conduct a study to investigate the association between periodontal status and Kidney health in Saudi patients.
Is it logic to examine randomly selected patients in dental clinics (with unknown systemic diseases) to check periodontal health (1st variable), and then send the patients to nephrology unit to check kidney health (second variable)?
I am looking for a funding/ research grant database where you can easily search for upcomming grants based on your interest. Preferably where you can have a personalized account that stores your searches and sends you e-mail alerts.
There are quite a few USA based ones but I think they might be less relevant when living in the Netherlands. My interest is in health/ clinical research (hospital based).
Researchprofessional.com seems promissing. Could anyone recommend other databases?
We are currently investigating an integrated treatment module for patients with PTSD and a comorbid eating disorder. Due to the novelty of the treatment, we wish to asses treatment acceptability (TA).
Sekhon et al., (2017) describe TA as ‘a multifaceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention’. TA appears to change over time, as various authors state that prospective TA, concurrent TA and restrospective TA may differ. Furthermore, clinicians and patients may differ in their perspectives on TA.
Serveral instruments have been developed, such as Treatment Acceptability/Adherence Scale (TAAS) by Milosevic et al., (2015), which measures prospective TA, or the Distress/Endorsement Validation Scale (DEVS, Devilly, 2004). Previous research has also utilized visual analogue scales or costumer satisfaction reports.
For patient TA, i'm thinking about administering the TAAS or DEVS at different time points (before, during or after therapy) to see how TA changes during the course of treatment. An alternitive idea would be to use a randomisation strategy, where each participant would either receive the questionnaire before, during or after treatment. It would be interesting to also assess therapist TA and to see whether or not these match.
Does this seem like a logical set up? Are there any methodological considerations to take into account? All feedback/suggestions are welcome, thanks in advance.
Hi I am a new Clinical Researcher and need suggestion about citation manager. I am doing a systematic review and need a citation manager which has the maximum flexibility. I know little about Endnote but no idea about Zotero. Need help to make a decision.
I know Zotero is free but that's not a big issue . I need to know which one is the most potential in terms of wide range of managing and writing options.
I work in a clinical research area where we give study drugs, usually intravenously, then draw PK's and other drug levels at specific time points following the administration. We have some investigators that say all post-administration blood draws must be done peripherally. While others say that after flushing a CVAD well and discarding some "waste" blood, the CVAD can be used for blood draws. of our patients have very limited peripheral access, so a peripheral blood draw may be impossible. Does any know if using a CVAD can skew any results or not? And if so, how long or how much fluid must go through the CVAD before it is considered alright to use? Thanks for your input.
Wondering if anyone here has done this Certification course before and can give a review. Is NIH Introduction to Principles & Practice of Clinical Research course worth doing?
This discussion section is about to Explore the issues that medical providers - doctors - nurses face during their battle, share your experience on covid unit,
In addition which factors facilitated in supporting you(mentaly and physically)?
How good does the developed protocols and plans of preparedness work on your facility?
Thank you for your time!
I am looking forward to your replies
I'm about halfway through a clinical trial for a behavioral health intervention (software). Our attrition rate is approximately 33%, i.e. 33% of participants do not make it from baseline to 30days. I am calculating effect sizes for each time interval in our preliminary data analysis.
Should I include the dropped participants in the Cohen's d calculation?
More specifically, d = M2-M1/SD, should I include dropped participants in M1?
A number of clinical researches are going on. At the same time, outcomes of the completed clinical researches are published. they are at different stages of accomplishment. every research leads a future prospect. it seems research is a continuing process.
What is your recommended analysis for the following problem:
I have 3 (treatment) groups and a non-randomized pre-post design. I want analyze the effects of the groups on the follow-up measure, controlled for the baseline measure.
If the pre-post measures were continuous, I would go with ANCOVA, using the follow-up measure as the dependend variable, the group variable as the factor and the baseline measure as a covariate. But what is your recommended analysis for binary pre- and post- measures?
* 3 treatment groups
* binary outcome (follow up)
* controlled for a binary covariate (baseline)
Thank you in advance for your help .
We measured the number of epileptic crisis every 2 weeks for 42 days in patients using a placebo-controlled design. At different times of the experiment, some patients leave the clinical research protocol.
At the time of statistical analysis we did not find normality in neither Active group measurement, nor Sham ones, but we found homocedasticity.
We used Skillings-Mack test for intra-group analysis in Active group... We need a method to compare between groups.
Is there any non-parametric test like two-way repeated measures ANOVA for this case?
I am doing a clinical research on how the oseotomy direction (angles) affects the amount of the displacement of the bone,
the problem is, I meaured all the angles, and want to put them into three groups, like anterior cutting, neural cutting, and posterior cutting.
But as theres is no refernece for this paper (it is a genuine thing), i don't know hot to divide these patients and put into specific groups.
Would it by using mean and stadard deviation, so that putting anterior cutting and posterior groups who are out of 2 standar debvation?
I think if i do so, there would be too much with neurtral patiens, and little of anterior or posterior.
How do you usually put the patients of your measurements into the group definition?
I am looking for some guidance on the appropriate statistical analysis for part of my study. I am looking at outcomes related to infection among 7 different groups based on source of the infection. I want to compare significance between all groups. For example:
Source 1: 2 Dead, 15 alive
Source 2: 9 Dead, 12 alive
Source 3: 9 dead, 5 alive and so on for 7 different groups.
What would be my best test to run? Thank you.
Recently GCP training is mandated for all researchers proposing to do clinical research? Who could impart GCP training? is there any official document specifying the qualifications of the trainer and the topics to be covered in training?
I am analyzing a dataset. There I have 4 variables that are used to diagnose a disease. Among them, 3 were "Lab test report findings" e.g. Test A, Test B, Test C and 1 "clinical findings" i.e. "Test D (which is obtained by the clinical examination of the patient and is not established for the confirmatory diagnosis of the disease).
To confirm the diagnosis of the disease e.g. "Dengue", Each of the 3 lab tests i.e. A, B, C can independently be used for the confirmatory diagnose of Dengue. In my research, patients had done at least one of the 3 tests to confirm the disease. Some might have done all the 3 tests.
Also, among the patients, a great proportion had shown the positive result of the "Test D".
I want to establish that, the "Test D" could be one of the confirmatory tests along with the other 3 tests i.e. A, B, C. On top of that, "Test D" could be more accurate and reliable to confirm the Dengue compared to other lab tests i.e. A, B, C.
So, what statistical test should I be used to prove and compare the effectiveness of this clinical examination findings? Also, suggest me some graphs, that can visualize with this case)
N.B. All 4 tests had a dichotomous answer. The findings of these tests can either be positive or negative.
According to my sample size estimation, the sample size comes to be 14. Would results from a trial with such a little number of subjects be valid? On the other hand I cannot increase the sample size beyond my calculated sample size except for adjustment for loss to follow up. Please suggest me.
A clinical trial was designed to have one interim analysis, hoping for early termination. Sample size was calculated using the O'Brien and Fleming spending function. Due to overrun of randomizing patients, early termination became unlikely, therefore it was decided to skip the interim analysis. How this decision will affect the study design - sample size, power, etc.? How the changes have to be communicated to regulatory authorities?
If an idea or concept from an ongoing study is used to perform a different study in a separate institution, how should the originator of the idea be acknowledged? Should the person be simply mentioned in the acknowledgements section or should author contribution be given?
These Questionnaires are extensively used in both clinical and research settings. Berlin questionnaire has more questions and assists the patient snoring. But one disadvantage is that it only categorise patients to high or low risk. While STOP-bang questionnaire is shorter but it categorise patients to high , medium and low risk.
We are conducting a cross sectional study to find the prevalence of possible obstructive sleep apnea among dental patients based on sleep apnea questionnaire and oral findings (airway, tongue size...).
My question is: Which one of these questionnaires is recommended for such study?
I'm investigating the benefits or pitfalls of including lay or plain-language summaries with clinical studies. There are a lot of arguments for it (see research piece:
Preprint PLS and patient engagement
Would you consider this good, bad, necessary ....? What should a lay summary include as a minimum to ensure the paper is correctly represented? Is a different skill set required to write a lay summary - should the author write it or should it be written by an objective reviewer?
We are clinicians, passing maximum time of our lives with many indoor patients. Quite often we observe some clear better outcomes or deterioration by certain regimen or management. We want to share this instantly in scientific way to other fellows but complexity of research methodology suppresses our eagerness many a time. Methods take lot of time and ultimately the intention disappears. Do you also feel it sometimes?
A subject in a trial had a significant reduction in both WBC and absolute neutrophil count. The decrease of white blood cells seems to be linked with the reduction of neutrophils. I was wondering to know if the two events need to be report separately.Thanks!
Estamos en búsqueda de Centros de Investigación y oftalmólogos interesados en Investigación clínica en México.
Do compromised "experts" play too large a role in marketing products for the large multi-national Pharmaceutical drug companies?
And what do we do about it?
I am looking for a platform for an efficient implementation of a Electronic Medical Records or Electronic Health Records
We are doing research on one drug which has powerful sedative effect. But recent clinical researches indicated that this drug had analgesic effect. We are planning to test this analgesic effect in mice or rat. But we don't know how to exclude the sedative effect on its analgesic effect. Could you give us some suggestions?
Thank you in advance!
How to decide total duration of treatment ( Ex: 12, 24 hours drug administration) and dosing schedule/ interval for NCE's in clinical research?
Is there a threshold by which 24-hr Blood Pressure needs to be reduced by to be clinically relevant?
or is it possible to use the clinic-based blood pressure thresholds?
any papers would be appreciated.
My team is currently running several clinical research projects and we are in need of dedicated researchers who are able to contribute to our projects at different levels.
Collaborations may include literature review, data extraction from research papers, statistical analysis, and drafting a paper. The collaborator will be listed as a coauthor in the published paper and his/her place in the author list will be determined upon the level of contribution.
If interested or know of anyone seeking collaborative medical research, please contact me at the following email address:
We will be more than happy to work with you!
I am currently planning an RCT. We originally planned a research design with an intervention group and a waiting-list control group and two measurement points (t0 at baseline and t1 as a 3-month follow-up).
We planned the control group as a waiting-list primarilly as an incentive to enhance participation in the trial for the control group participants and so we originally did not intend to use (or even measure) post- treatment data from that group in the statistical analysis. For this design we planned to analyze the data using an ANCOVA with time (t0, t1) as a covariate. The calculated sample size is N=128 (f=0.25, two groups, one covariate, alpha=0.05, power=0.8).
Now we we are required to include post- treatment data from all patients that received the intervention. What are your statistical recommendations for using post- treatment data of the waiting-list group?
I considered to use 3 groups in the ANCOVA (A: intervention group with its t0 and t1 measures, B: waiting-list group prior to the intervention with t0 and t1 and C: waiting-list group with their pre- intervention t1 and post- intervention t2). This would not affect the power calculation as only the number of groups would change from 2 to 3. But I do not consider such an approach as suitable because the two groups from the waiting list would not be independent. Additionally, this approach would use an unequal randomization ratio of 1:2.
I think, a mixed linear effects model also would not be suitable as the intervention group has data from two points of measurement and the waiting- list group is measured three times.
I have a question.We did a clinical research for measuring a specific CD marker in special patients. But we forgot to measure it in normal people. Can we use the measurements of this marker as a controller from other researches in our article?
Do journals publish such work?
A discussion about whether to start clinical research by writing review articles or original papers.
Drug companies and medical devices industries provide financial support to clinical researchers, to medical meetings and also provide direct and personal support to physicians paying their travell expenses. How do you criticize those financial relations among health care industries and doctors? Are they ethical ? Should they be cancelled? Drug Advertising or Marketing of drugs should be forbidden? Do they influence clinical decisions and research results?
As a newbie and low-budget neuroscience researcher, i'm looking for webcam based eye tracking softwares, which can measure ''duration of initial fixation'', ''total fixation duration'' and ''area of interest'' accurate and precisely.
I found gazerecorder, and somekind of out of date project;
is anyone recommend me, or used webcam tracers in their clinical research?
thank you for your answers,
I have questions, which reviewers usually raise the questions in a clinical research.
1. I do a clinical research; let’s say clinical outcomes of a surgical procedure. I have total number of operated patients are 50 in a particular time (let’s say -2014-2016) and I want to measure the postoperative outcome of that patients. How can I calculate a required sample size?
2. In a comparative study, I want to compare the postoperative outcome of a surgical procedure in two different groups of patients who underwent that particular surgical procedure in a particular time period (Let’s say between 2014-2016), Group A has total cases 50 and B also has 50. Now I want to compare the clinical outcomes of improvement of 2 groups of patients. How can I calculate a required sample size?
I am asking these questions because I have limited cases in that particular time period and there is no way that I can increase the sample size. So, how can I justify that I have adequate sample size?
Thank you and expecting your favorable response.
I am a student brand-new to clinical research. I read 10 chapters of Andy Field's Discovering Statistics Using SPSS to prepare myself to perform the statistical analysis on my research paper, and followed his steps closely. Do you have any suggestions on how I might best check my work? Is consulting a professional or faculty necessary, or are there rigorous methods to assure that I've correctly calculated everything?
I am trying to assess the capacity of clinical research sites and organizations in West Africa to conduct vaccine trials. I have designed a questionnaire, but i need to get a listing of these organizations with contact details. Online clinical trial registries have provided some details but they are very scanty. Also, it excludes those sites that have not been actively conducting or registering clinical trials online, but which, with a little push can be fully functional centers.
Can anybody PLEASE offer suggestions?
I'm planning to do a research based on questionnaire/ survey and population are clinical researchers from the whole country. The count of researchers in the country in unknown (I don't know how to get this info). My aim is to publish the results.
1- How to calculate the sample size?
2- Should IRB approve the research?
3- What is the least number of questions they should answer to be included in the stats? or percentage
4- Can I cite the same article(s) in more than on research? The information found in these articles are relevant and I can use for literature.
Thanks in advance.
It is recommended in some references to avoid the combination of metronidazole & mebendazole as the risk of steven johnson's syndrome is increased.
1-are there any statistics reg the prevalence of this interaction?
2-is it common in specific populations rather than others?
3-is it strictly contraindicated or just cautious?
4-are there any recommendation for spacing intervals if both needed?
In clinical research, some of the fundamental ethical issues that arise are the issues of exploitation, induced consent and an exposure of a research participant to an unjustifiable risk. If a pharma company deploys researchers from America to Nigeria with the aim of testing a trial drug that would be used to cure cancer, can this be an act of exploitation? What of if the participants were given some incentives before they were involved in the research protocols, could this be interpreted as a kind of inducement? How can these questions be addressed with the principle of equal moral consideration and human rights?
I have to find a topic for my master study (Biotechnological Qualitymanagement). The planned direction would be Good Clinical Practice / Clinical Trials.
I have started an MSc in Physiotherapy and am interested in the abovementioned area of (neuro-)rehabilitation.
Also I am interested in HIIT in the elderly, the frail and chronic stroke patients.
Any information is welcome! I am ready for information overkill!
Are there specific educational courses or a formal degree required in YOUR country to become a clinical researcher?
OR does YOUR country allow for on the job training alone?
What are the government's requirements to practice as a clinical researcher?
I am seeking what is required in specific countries, not the general WHO requirement.
Thank you for your input inadvance
I would like to know, how the sample size will be calculated for clinical research. In Ph.D seminar presentation. some of the panelists suggested taking 100 patient in each group (3 groups). But I am trying to choose only 50 per group as my condition of study is rare - unilateral neglect in stroke. please suggest.
The government in low-income countries give less priorities for research. As a consequences, It is difficult for researcher to generate fund for research which play a crucial role for sustainability of researcher. Please suggest international funding agencies who promote clinical research activities in low-income countries. Your suggestions are appreciable.
According to the Mayo clinic research, is laparoscopy the gold standard for colon/rectal cancer surgery? what is your approach regarding colonic neoplasia, right of left side or rectal cancer, there is any place for laparoscopy in your practice?
I wonder whether there are some known and widely discussed cases of human disorders caused by SNP (or set of SNPs) in one case and by large-scale genomic rearrangements in other.
How these complex cases are treated in medical practice? Are there any tests available covering different sources of such disorders?
I theorise that such cases might arise from interruption of TAD boundary in chromatin (either CTCF binding site mutation or some deletion/sophisticated rearrangement of TAD boundary).
But I'm rather interested in particular cases known for medical practice. Any ideas?
Two types of forgiveness, conditional or unconditional, can be distinguished. The first establishes conditions to grant forgiveness and tries to avoid the repetition of the offense. The second considers that forgiveness is a gift that depends entirely on the offended person and not on the behavior of the offender. However, several authors say that this unconditional forgiveness is impossible to achieve. I would love to know if you have known experiences of authentic unconditional forgiveness in your clinical or research work.
I have secured several "informed consent" to terminate life-support after more than twenty years in medical practice, but the number of cases does not make the subsequent cases easier for me. I find every case ethically and legally taxing. One of the most common and challenging issue I have to face is an immediate family member asking me "[W]ho will switch off the device?" In our country, there is no law yet governing end-of-life decisions.
monoclonal antibodies may be better than polyclonal antibodies is certain clinical and research applications. But when used as the primary antibody in Western blotting or immunohistology procedures.
Someone can help me? I have listened informally, but I can not find really formal and conclusive answers on the following questions: 1- Are there well-established and consolidated scientifical data about the efficacy of the use of rolipram, thalidomide, pentoxifylline or rupatadine, alone or combined, in the treatment of rheumatoid arthritis? 2- Are the existing data obtained in studies with experimental models of rheumatoid arthritis sufficient to point out conclusively and clearly the possible beneficial or deleterious effects arising from the use of each one of these drugs in this disease? 3- Would such eventual data be sufficient to justify clinical trials of each one of these drugs in patients with rheumatoid arthritis whose conventional therapeutic drugs are withdrawn?
As example: Drug A (Km=2uM), drug B (Km=45 uM). If we do inhibition or DDI study with known inhibitor and found IC50 for drug A is higher than drug B. what will be the explanation of the result (IC50 or Ki) for two drugs (A and B)?
Is it necessary to keep subject under monochromatic light or sodium vapour lamp if administered with mesalamine? what will be impact on sabject safety or study data if blood sample collection is done under normal light?