What are clinical trials?

Scientists follow different methods to test their findings. While it involves observing the subjects in a normal setting, sometimes these can be achieved through questionnaires, medical exams, tests, etc. When scientists come up with a new drug, medication, or therapy, and it is required that a study is performed directly on people who are targeted for the product – it is known as a clinical trial. It is performed to evaluate the efficacy of the treatment at an early stage, and also helps find out if there are any possible dangers or side-effects.

Sometimes, clinical trials are also performed to detect early symptoms of a disease. Every medication approved by the FDA (United States Food and Drug Association) must have performed clinical trials before it can be marketed.

Importance of clinical trials

 Clinal trials help find the best-suited medical procedure or drug to cure a disease. The results of these trials help with feedbacks on the research front in order to improve the intervention.

For any new therapies to be suggested to the patients, it’s important to conduct clinical trials. They form an integral part of medical research because it not only helps find newer ways to cure but also provides ways to reduce the chances of developing the disease.

How are these trials performed?

Clinical trials are well planned and conducted by a group of scientists or researchers. The person-in-charge of these trials is called a principal investigator, and he/she is the one who manages the team of researchers.

The trials are conducted using a protocol that includes details about the objective of the research, a number of subjects required, eligibility criteria, age (if applicable), information required (blood, stool, urine, etc.), and the treatment plan. It might involve a single test or a set of tests at different intervals or all at once. These steps are taken by the medical practitioners in order to avoid any kind of bias that is irrelevant to the protocol.

Here is what happens in a trial:

  • Details about the subjects are gathered by one of the study staff, and information about the trial is given.
  • The subjects can ask questions related to the study.
  • A consent form is then signed by the subjects giving permission to proceed.
  • Screening is done to find out the eligibility, and a first visit, also known as the baseline visit) is scheduled.
  • The subjects are assigned to a treatment, a therapy, or a control group and the family members can followup to report any concerns or issues.
  • More visits are scheduled to evaluate the impact of the intervention.
  • The subjects can visit their physician for usual health concerns regarding ongoing therapies or drug intake even during the period of the study.

 

How to find a clinical trial?

 Those who wish to participate in a clinical trial can find out more information online by simply running a keyword search. You can also consult your general physician to help you connect to an association or support group in your area.

CPhI grades Japan in the second position for Pharma

Industry supervisors envisage Japan to be the second fastest growing mature marketplace for solid dose drugs in 2019 followed by the United States. The findings represent a considerable year-on-year improvement in outlook for pharma in Japan with expected growth of solid dose formulations improving by more than 10% with generic drug classes highlighted Significantly, it ranks ahead of all EU nations and Korea. The report concludes that Japan is a ripened country for growth across a number of product classes, but the enduring winners of regulatory changes and innovative R&D remain hard to pick.

Reference Link: https://biospectrumasia.com/news/50/12865/japan-second-fastest-pharma-growth-in-2019-cphi-report.html