BRIEF REVIEW ON CLINICAL TRIALS
Potential problems in clinical trials:
- Firstly there is no common acceptance from experts upon the definition of the clinical research.
- Secondly, an imperfect public understanding of clinical research, it means that a relatively small percentage of people who volunteer to participate in clinical research trials for example, for adult patients with cancer, the volunteer rates are only five percent.
- Third problem is that the data are inadequate to tell whether investment in clinical research is being well spent or not.
- Fourth problem is about the insufficient funding in certain areas of clinical trials.
- Fifth and sixth problem is related to work force issues involved in clinical trial.
- The seventh problem is poor coordination between Health Management Organizations (HMOs) and the academic medical centers, between schools of nursing and schools of medicine on the other.
Payment to Research Participants:
- Research participants provide a valuable service to society. They take time out of their daily lives and sometimes incur expenses associated with their participation in clinical trials. When payments are made to research participants.
- Any proposed payment should be reviewed and approved by an independent IRB/EC.
- Payments should be based on research participants, time and/or reimbursement for reasonable expenses incurred during their participation in a clinical trial, such as parking, travel, and lodging expenses.
- The nature and amount of compensation or any other benefit should be consistent with the principle of voluntary informed consent.
Payment to Clinical Investigators:
Payment to clinical investigators or their institutions should be reasonable and based on work performed by the investigator and the investigator’s staff, not on any other considerations.
i. A written contract or budgetary agreement should be in place, specifying the nature of the research services to be provided and the basis for payment for those services.
ii. Payments or compensation of any sort should not be tied to the outcome of clinical trials.
iii. Clinical investigators or their immediate family should not have a direct ownership interest in the specific pharmaceutical product being studied.
iv. Clinical investigators and institutions should not be compensated in company stock or stock options for work performed on individual clinical trials.
v. When enrollment is particularly challenging, reasonable additional payments may be made to compensate the clinical investigator or institution for time and effort spent on extra recruiting efforts to enroll appropriate research participants.
vi. When clinical investigators and their staff are required.
vii. To travel to meetings in conjunction with a clinical trial, they may be compensated for their time and offered reimbursement for reasonable travel, lodging, and meal expenses. The venue and circumstances should be appropriate for the purpose of the meeting.
In conclusion, we have came to know about ethical data behind Clinical trials, institution review board/independent ethics committee, ICH GCP, role of FDA, investigator and institution,documents required for the conduct of a clinical trial, Clinical trial Protocol, types of clinical trials, phases of clinical trials, experimental methodology. Clinical trials are designed to answer a specific question about a treatment, usually the safety and efficacy (how well it works under optimal conditions) of the treatment. Volunteers who meet specific criteria, including having the condition being studied, receive an explanation and, if they choose, join the trial. This informed consent process should include explaining the random treatment assignment as well as the risks and possible benefits of the trial and often includes a written form to document those issues and the volunteer’s consent. There are many regulatory requirements for new drug development and approval. Clinical trials are an integral part of the new drug discovery and development process. Before a new medicine can be made available, evidence of its safety and effectiveness must be provided by well-designed, well-controlled, and carefully monitored clinical studies in healthy volunteers and/or patients consenting to participate. Beyond conducting high-quality trials, Roche is committed to providing healthcare stakeholders with full transparency on risks associated with its clinical trials and ensuring the protection of patient safety as well as patients’ personal data. In all cases, the procedures and results mustbe documented appropriately. From a regulatory perspective, if the research is notdocumented, for all intents and purposes, it has not been done.At the completion of the clinical trials conducted using an investigational new drug,and the completion of all nonclinical studies being conducted contemporaneously,New Drug Application (NDA) is filed. The regulations pertaining to NDAs are located in 21 CFR 314 and, as for INDs,provide detailed guidance for both content and format.Typically, sponsors meet with the FDA to discuss the content and format ofan NDA prior to its preparation.
5. Guideline for Good Clinical Practice, (2002), European Medicines Agency, ICH Topic E 6 (R1), 5-48
6. Turner JR., (2007), New drug development: Design, Methodolog and analysis, John Wiley & Sons, Inc., New Jeney, 41-201.
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