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Crohn's disease

Crohn's disease is an ongoing condition that causes inflammation of the digestive tract, or the GI (gastrointestinal) tract (the gut).
Clinical Trial Supplies/IMP
  1. After completion of the clinical trial before getting marketing approval, is it accepted to continue the treatment of investigational product to the patients?
    World Medical Association: Declaration of Helsinki-Ethical Principles for Medical Research involving Human Subjects states that at the conclusion of the study, every patient entered into the study should be assured of access to the best-proven prophylactic, diagnostic and therapeutic methods identified by the study. It is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.
  2. Is it required to conduct clinical trial for a modified dosage form of their conventional dosage product?
    If the modified release form is a pharmaceutical modification, which does not have potential to change the pharmacodynamic properties of the drug, there is no need for pre-clinical studies.
  3. Is CRO responsible for retaining the clinical trial drug samples?
    If the contract between sponsor and CRO gives this responsibility to CRO, then CRO will be responsible for retention. The following guidelines refer to retention of samples.
    ICH GCP 5.14.5: The sponsor should maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
  4. When investigational product (IP) should sent to the site? What is the minimum requirement?
    Has to get Regulatory and Ethics Committee approval before sending IP to the site.
  5. For IND application what is the quantity of investigational products sample to be retained and for how many years? Who is responsible to retain it?
    The requirements for sponsor are as follows: This relates to batches used in trials at any phase.ICH-GCP suggests 5.14.5 the sponsor should: (a) Take steps to ensure that the investigational product(s) are stable over the period of use. (b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.
  		 


Opinion Poll

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This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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