Benefits and Risks of Clinical Trials

Today, medical research has become one of the important components contributing to the Indian economy. Further, it is a significant field of study which helps towards providing advanced medical treatments and cure. Both public as well as private sectors are included when it comes to developments in the medical research field.

In the recent years, India has seen tremendous progress in the field of technology and science with several multinational pharmaceutical firms planning to launch themselves in India and initiate many research programs in the country. The Government of India has always offered its support as well as guidance towards the progress and development of these research endeavors. Due to this it has become immensely important to effectively explore the authenticity of the treatment, medical strategy and equipment.

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

Clinical Operation Services

Clinical operation service is one of the most crucial aspects of the clinical research.The Clinical Operations is the key process for the delivery of clinical trials. Without Clinical Operations Clinical Research activity could never be delivered. Clinical Operations teams are responsible for designing, planning and physically running Phase I – IV clinical trials.

Tailored solutions are designed by the experts in conjugation with the clients to get the appropriate output within stipulated time and budget.

Remote Monitoring of Clinical Trials

Remote monitoring for clinical trials is very important, as it offers real-time management of data along with the proficient monitoring procedure. It is an online system that allows the professionals to access the data with ease. Once the data is fed in the system, it can be accessed by everyone to avail the optimum benefits. Integrity is maintained while collecting and maintaining the data, as this paves an appropriate path for the systematic clinical trial.

RSM allows monitoring activities which were previously conducted on-site to be conducted remotely, increasing efficiency and speeding up time to market. The CRA does not spend time onsite, instead the CRA performs all the study monitoring processes remotely, using a secure online platform.

The major benefit of Remote Site Monitoring (RSM) is that the CRA indeed spends much less time, if any, at the clinical sites. When you consider that an average of 30% of the total clinical study budget is spent on CRA sites visits, it is easy to understand that RSM are quickly becoming key elements of the global study process.

Why Clinical Trial?

Clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.

Although “new” may imply “better,” it is not known whether the potential medical treatment offers benefit to patients until clinical research on that treatment is complete. Clinical trials are an integral part of new product discovery and development and are required by the Food and Drug Administration before a new product can be brought to the market.

Benefits of the Clinical Trials

Let’s check the benefits offered by the method of a clinical trial:

• Access to promising new treatments often not available outside the clinical-trial setting
• Treatment that may be more effective than the standard approach
• Close monitoring, advice, care, and support by a research team of doctors and other health care professionals who understand your disease or condition
• The opportunity to be the first to benefit from a new method under study
• The chance to play an active role in your own health care and gain a greater understanding of your disease or condition
• The chance to help society by contributing to medical research. Even if you don’t directly benefit from the results of the clinical trial you take part in, the information gathered can help others and adds to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care.

Risks involved in the Process of Clinical Trial

Along with the numerous benefits, clinical trials also involve various risks. Let’s have a look at those:

• It demands frequent visits to the lab than the non-clinical trials.
• Doctors can ask to stay at the hospital for close monitoring.
• There might be some serious side-effects of the trial method that can be life-threatening.
• The experiment might work for some but there are chances that it won’t work for a few of the people.

Conclusion

Clinical research in India is improving with the help of the latest technologies, government facilities and improved regulations / framework.

Clinical research has opened up many lucrative job and business prospects in Clinical Operations, Medical writings, CDM, Pharmacovigilance.

Capable professionals are getting an opportunity to showcase their talent in the field of research with an aim to serve the mankind in a better way.