Few Basic Questions Regarding Clinical Research and Clinical Trial
1. What is clinical research?
Clinical research is the branch of health care where, the research is conducted from the drug discovery till it marketed. In which there are so many phases which will describes the journey of drug discovery. Now a days this field is blooming one where the life science graduates has the great opportunity for the stable career path
2. What are the Clinical Trials?
Clinical trials are the process in which the drug is introduce in human being to check the efficacy and safety of drug towards human health and disasters. The major need and purpose of clinical trials are there are so many molecules which has tremendous capacity of curing a disease and once this molecule found compatible with particular disease will turned to go through the clinical trial where we have to check the safety and efficacy parameters on humans.
3. What are clinical trial and the process?
Step 1- found the molecule for targeted disease
Step 2- conduct a pre clinical trial (animal study)
Step 3- submit pre clinical data to regulatory
Step 4- proceed for clinical trial
4. While once the data is generated from pre clinical trial phase are started meanwhile the pre-clinical is consider as phase
Now there are 4 major phases of clinical trial as,
A. phase 1(preparatory phase)
B. phase 2(confirmatory phase)
C. phase 3(therapeutic phase)
D. phase 4(post marketing)
3. What is clinical data management?
Clinical data management is the tool used in clinical research when the data is generated i.e. when subject’s visits are done at site level; the generated data is proceeds in CDM on various softwares like MeDra, oracle, etc.
The data is reviewed first of all then the analysis of data on the basis of valid compliances.
4. What is ICH-GCP?
It’s a joint initiative between industry and the regulatory to line up the unique way which follows the standard sets of rules and regulations along with the preferred guidelines which are concern of GCP, ETHICS, and REGULATORY requirements
This guideline are comprises the set of standards as,
1. Safety of subject rights and confidentiality is the main concern
2. The clinical trial should be In accordance with GCP, Ethical requirement and regulatory requirement
3. Foreseeable risk and benefits of study drugs should be justifiable
4. IRB reviewed protocol is only consider with compliance one
5. Everything which is part of clinical trial should be quality assured.
5. What is ICF?
Its inform consent form this is the consent of subject voluntary participation in clinical trial. This is the only document where subject details i.e. the name, address; date of birth is mentioned along with the initials for identification.
In this concept the clinical trial background and general information is given to subject about the drug and study design, compensation, policies etc.
Ethics committee and the PI details are given through this consent
This is the only document which is not transferable to anyone to maintain the confidentiality of subject (patient) details that’s why this document is most important while participating a subject into the clinical trial.