Clinical Trials, Bioequivalence and Bioavailability Studies, Clinical Studies

• Latifa Berrezouga

  Hello how do you explain the effect of the placebo ? is there a psychological explanation ?

  In placebo-controlled double-blind clinical trials, the placebo could have an effect on studied patients (10%, 15% or even more), even if the tested drug is the molecule of concern. Thank you

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    Roland Eghoghosoa Akhigbe replied

    The effect of placebo could be due to its bioactive constituents. However, it is mainly psychotherapeutic.

    2 hours ago
• Akihiro Shiina

  Do you inform participants of their drug or placebo status after completion of clinical trial?

  We often plan a placebo-controlled double-blind clinical trial for investigating the effect of new drug. For strict evaluation, the administrator does not inform the participants which they areWe often plan a placebo-controlled double-blind clinical trial for investigating the effect of new drug. For strict evaluation, the administrator does not inform the participants which they are given, the real drug or placebo. The doctor in charge is also blinded to avoid Pygmalion effect. However, even after the trial is completed, is there a reason to forbid informing the participants which they are given?

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    Harshawardhan Mohan Mardikar replied

    I am discussing the scenario where drug has shown beneficial effect but it is not available in the market.Then sponsor company has responsibility to provide drug to patient at his own risk till thatI am discussing the scenario where drug has shown beneficial effect but it is not available in the market.Then sponsor company has responsibility to provide drug to patient at his own risk till that time approval is granted.

    6 hours ago
• Vishal Sharma

  ICH-GCP is the perfect guideline for drug trail. I think ICH GCP is the best guideline for clinical trail, but there is some room of improvement.

  According to ICH GCP, there are 13 guidelines for drug trial. But in my view it is not sufficent to control the illegal trials. Many of drugs trials in the second phase give a harmfull effect but theAccording to ICH GCP, there are 13 guidelines for drug trial. But in my view it is not sufficent to control the illegal trials. Many of drugs trials in the second phase give a harmfull effect but the trial was continued.
• Kevindra P Bhajbhuje

  How we can identify that an enrolled trial subject is fake and the investigator is enrolling subjects only on paper?

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    Kevindra P Bhajbhuje replied

    Thank you all for your valuable comments..As CRC and Investigator both work at the site and favors each other its become difficult for monitor to do this job....Yes VINAY SINGH, lab records andThank you all for your valuable comments..As CRC and Investigator both work at the site and favors each other its become difficult for monitor to do this job....Yes VINAY SINGH, lab records and reports can be useful tool for identifying whether patient do exist in real or not.

    15 days ago
• Miriam Mayta

  Oral contraceptives and Breast Cancer

  Is there any meta-analyses that confirm the relationship between breast cancer and oral contraceptives?

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    Miriam Mayta replied

    Thank you all of you, specially Constantine Kaniklidis!!. I´m very grateful for your answers :)

    21 days ago
• Teresa Lalitha Kumari Balla

  ICT cards for filariasis

  Does any body know which company in India markets ICT cards to test for filariasis?
• Subramanian Loganathan

  Sample size justification for partial replicate bioequivalence study (reference-scaled approach)

  Is there a sample size justification for partial replicate bioequivalence study? (reference-scaled approach)? On what basis is sample size determined? Thanks.

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    Subramanian Loganathan replied

    Thank you for your valuable comment venkateshan.

    Apr 5, 2012
• Marisa Toups

  What have people's experiences been with software packages for clinical trial data collection?

  We are currently doing a trial using StudyTrax and have found it frustrating to use. I'd like recommendations/reviews of clinical trials software for future projects. I do mental health research soWe are currently doing a trial using StudyTrax and have found it frustrating to use. I'd like recommendations/reviews of clinical trials software for future projects. I do mental health research so our needs maybe a bit different than other areas of medicine.

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    Raymond Omollo replied

    Maybe this is late in the day but i concur with Clemens that openclinica is an option worth considering. We have used it in clinical trials for NTD's over the last 4 years and we are liking it.

    Apr 3, 2012
• Senthurselvi Aravinth

  What should be the dose of oral curcumin in inflammatory conditions?and how long should be given?is there any articles regarding the doses?

  I am doing a research with Curcumin so I need to know.

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    Senthurselvi Aravinth replied

    Thank you..

    Mar 29, 2012
• Mohamed Khalil

  How can one find the measured data of a real case study, like the density of the virus of HIV, HCV, HBV, in a patient during a long period?
• Matthew Tanner

  Establishing protocols for a healthy living environment clinical trial

  I plan on starting a clinical trial in the near future and need some advice or resources about establishing protocols. First, the trial will be conducted to test if an antimicrobial paint improvesI plan on starting a clinical trial in the near future and need some advice or resources about establishing protocols. First, the trial will be conducted to test if an antimicrobial paint improves the healthy living environment in a nursing home. My questions are: 1) Can anyone point me in a direction where I can find information on creating selection criteria? 2) Anybody familiar with any examples of other healthy living environment studies? It doesn't necessarily need to be a study performed with a paint. It could be a study with air filters, cleaning supplies, etc.

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    Hamid Shoraka replied

    Dear Matthew I had any information about this type of super bugs disinfection, so, I need more study about that, but my long duration experience suggest me to plan study in a small or limitedDear Matthew I had any information about this type of super bugs disinfection, so, I need more study about that, but my long duration experience suggest me to plan study in a small or limited condition.

    Mar 6, 2012
• Madhu Sudhan

  Clinical research

  Clinical research has bright future for career options

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    dr trivikram Pareek replied

    I Am Jobless since last 6 months. I am a Doctor+ Masters in clinical research.

    Feb 29, 2012
• Omokhoa Adeleye

  How is reliability computed for a questionnaire from dichotomous responses (Yes/No) that are repeated or rephrased in other parts of a questionnaire?

  When the same questions (with dichotomous responses: Yes/No) are repeated or rephrased in other parts of a questionnaire and data collected with it: a. how can one proceed to compute reliability forWhen the same questions (with dichotomous responses: Yes/No) are repeated or rephrased in other parts of a questionnaire and data collected with it: a. how can one proceed to compute reliability for the questionnaire using responses from the repeated questions? b. given that kappa has been computed for each of the repeated questions, how can an aggregate kappa coefficient be computed for all the repeated questions?
• Vinay Singh

  Can anyone tell me why an experienced CRC can not become a CRA?

  Everyone is asking for monitoring experience to become a CRA.. Crc versus cra

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    Vinay Singh replied

    Dear Svet, Many thanks for your detail write up... I have tried by all possible means but its not working. I am handling site related activities for more than 2 years and it happened many timedDear Svet, Many thanks for your detail write up... I have tried by all possible means but its not working. I am handling site related activities for more than 2 years and it happened many timed that CRA is going with empty handed i.e. no monitoring findings at all.........

    Dec 29, 2011
• Papa Win

  I m doing pharmacokinetic of ethambutol level in patients with type II diabetes and renal failure and having TB. I wish to know that the clearance of ethambutol in patients with renal failure AnybodyI m doing pharmacokinetic of ethambutol level in patients with type II diabetes and renal failure and having TB. I wish to know that the clearance of ethambutol in patients with renal failure Anybody who know about pharmacokinetics of ethambutol in renal failure patients, help me please for guiding references