Tiêu đề 7. CHALLENGES IN THE IMPLEMENTATION OF GUIDELINES.pdf ✅

PHARMD GURU Page 1 CHALLENGES IN THE IMPLEMENTATION OF GCP GUIDELINES: Some of the challenges in the implementation of GCP guidelines are as follows: 1. Professional training on GCP 2. Infrastructure 3. Regulatory environment 4. IRB/IEC/ERB 5. ICD Administration 6. Safety reporting 7. Investigational product 8. Record keeping/source document(s) 9. Grants and payments 10. Trial report/publication. 1. PROFESSIONAL TRAINING ON GCP:  The scarcity of GCP trained competent professionals; pose a major challenge in the implementation of GCP guidelines.  There is a lack of professional training on GCP across various stakeholders (sponsor, investigator, ERB, patient, regulators, etc.).  Although some of the companies have, in-house training programs, but it is not uniform across industry, also no Indian University offers a curriculum in this discipline. 2. INFRASTRUCTURE:  Majority of the hospitals in India are not geared up to the meet the infrastructure requirements as per the GCP guidelines.  Lack of support infrastructure like labs and diagnostics, up to the standards of international accreditation is another hurdle in the implementation of GCP guidelines. CHALLENGES IN THE IMPLEMENTATION OF GUIDELINES
PHARMD GURU Page 2 3. REGULATORY ENVIRONMENT:  Inspite of well defined guidelines on clinical trials, the biggest challenge in their "implementation and adherence".  We do not have a regulatory inspection system in place to monitor the adherence and compliance to these guidelines in majority of circumstances adherence to GCP guidelines, is a matter of self discipline at the part of sponsor(s), investigator(s), and ERB(s). 4. IRB/IEC/ERB:  GCP guidelines require written standard operating procedures (SOP) for IRB/IEC/ERB.  However, there are no standard guidelines on what should be the content of an ideal SOP, so that there is uniformity across various hospitals/institutes.  Many of the hospitals either do not have the written SOP for ERB (or) have improper guidelines, not encompassing all the critical elements of GCP. Also, there is no provision to check whether the SOP is being followed during each meeting (or) not. 5. ICD ADMINISTRATION:  Administration of ICD is a major challenge in a country like India, when the patient/legally acceptable representative has such an immense faith on treating doctor that, they insist on signing the document, without ever reading it (or) after reading it superficially.  They feel that if the treating doctor is suggesting something, it would definitely help them (indirectly influence).  The wording and the content of the ICD are such that a layman is not in a position to understand the majority of the document. Situation becomes even grim when translations are used, which leads to varied interpretations, due to lack of authentic validation. 6. SAFETY REPORTING:  It is a joint responsibility of the investigator on the sponsor to report the entire serious and unexpected adverse event to IRB/ERB and the regulatory authorities.
PHARMD GURU Page 3  The regulatory Pharmacovigilance presently is not optimally implemented for adverse event handling and review.  In majority of cases sponsor does not even, comply with the expedited safety reporting to local regulatory authority & regulations often remain unaware of this fact. 7. INVESTIGATIONAL PRODUCT:  Investigational product storage, handling and access control is a major challenge in the implementation of GCP guidelines. It is difficult to produce any evidence of temperature chain being maintained during shipment of investigational product from sponsor’s facility to the investigator site.  There is no validation and regular standardization of thermometers provided by the sponsor.  Sometimes two thermometers in the same room give significantly different readings.  No standardized solutions are available for storing investigational product, requiring special storage conditions. 8. RECORD KEEPING/SOURCE DOCUMENT(S):  Record retention and retrieval is always a major challenge in majority of hospitals. The documentation of patient disease, treatment and progress notes is not adequate to meet the standards of good documentation practices that ensure data completeness and correctness.  For the hospital's using electronic records as source data/document compliance to CFR Part 11 is a major hurdle.  Archival of trial documents for the stipulated time frame, and under proper environmental control is again a challenge at majority of the hospitals. 9. GRANTS AND PAYMENTS:  Trial agreements are based on the institutional practices, where the research grants goes to a centralized research account, which in majority of the cases remains un-utilized.  There is no incentive to the investigator for investing extra time, efforts and intellectual capital.
PHARMD GURU Page 4 10. TRIAL REPORT/PUBLICATION:  Negative trials (or) trials that get terminated prematurely or rarely published.  This is a major threat towards the validity of evidence based medicine as one gets to know the posture results only.  The above mentioned challenges need to be addressed in order to perform the world-class clinical trials in compliance with GCP guidelines.