1. What is clinical research?
Clinical research is a branch of healthcare science that determines the safety and effectiveness treatment regimens intended for human use. It may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is different from clinical practice. In clinical practice one uses established treatments, while in clinical research evidence is collected to establish a treatment.
2. What are different phases of clinical research?
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies. Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.
3. What is meant by pre-clinical studies?
In drug development process, pre clinical studies which are also known as non clinical studies are basically the steps of clinical research prior to drug trials in human beings. These are initially carried out in laboratories and then tested on animals. Feasibility, iteration (repeating the process again & again) and drug safety data collection are important steps of pre-clinical studies.
4. What are the types of clinical trials?
Generally there are different classification models to differentiate different types of clinical trials. We will discuss here only one model which is based on the objective of the researcher where he starts the trial either with an objective of treatment or just with his observations. Hence there are two types of clinical trials, observational and treatment based.
5. What are different designs of clinical research?
Observational studies may be designed as cohort, case control, cross sectional, or ecological whereas treatment based trials can either be designed as randomized or adaptive. (all details are available in our section of ‘Research Resource Support’
6. Is there any ethical concern while conducting a clinical research?
Yes there are major concerns which are mandatory to be addressed while conducting a clinical research. Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Various organizations have created guidelines for it which we have shared in the segment of ‘Research Resource Support’
7. Which phase, type and design of research is recommended to be initiated in Pakistan?
We wish every type, design and phase research in Pakistan but we can support phase III & IV trials of all types and designs.
8. What is its scope in Pakistan?
It has two dimensions. On one hand it is the responsibility of growing pharmaceutical industry of Pakistan to come up with research work and on the other hand it is a big opportunity as it is relatively uncommon so can give a big competitive advantage if carried out professionally.
9. Which type of infrastructure is required by a pharmaceutical company to initiate a clinical research project?
As it is not a lab based study so pharmaceutical companies do not need to establish an infrastructure for it. These used to be carried out in tertiary care hospitals where its proposal, protocols, methodology and analytical work will be carried out by the team of professionals at Holistic Research Solutions.
10. What are the benefits for a corporate by doing clinical research?
Clinical research is a magical tool for the growth of pharmaceutical business. Short term growth is usually seen by the institutions where the research is going on due to the repetitive message of the brand as well as improved brand image in front of clinicians of that institution. Long term growth is seen after completion of the research work when it is presented at any reputed forum, or published in a reputed journal and through its subsequent effective use by the marketing department. This long term benefit can upgrade the brand even at the position of brand leader.
11. What is the guarantee that the results of this research will be in favor of our product?
You can find its guarantee only by your quality assurance and quality control departments.
12. Does Holistic Research Solutions (H.R.S) has the capability to get its research presented and published nationally and internationally?
Of course we have a team of experienced professionals who have their post graduate studies in respective departments, experience of respective segments nationally and internationally. If you abide by the protocols given to you for the research work, we can ensure you that as far as the research parameters are concerned, our research work will be comparable to any of the research institution of the world.