EFFECTS OF GROWING GLOBAL CLINICAL TRIALS AND POST-MARKETING STUDIES

October 21, 2023

EFFECTS OF GROWING GLOBAL CLINICAL TRIALS AND POST-MARKETING STUDIES

INTRODUCTION:

The research studies that test and conducting treatment by using newly discovered or invented drugs or medical products (cosmetics) on volunteer people to evaluate the effects on human health by its outcomes or test the medical, surgical and behavioural intervention in people is known as clinical trials. So, the conducting of clinical trials in global level is a huge challenge and have both benefit and risks within. Also, have some barriers in the way.

In Clinical trials there are several phases, in that phase IV trials are also known as POST-MARKETING STUDIES.

Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.

PMS studies are conducted to assure the quality, efficacy and safety after they go into the market.

BENEFITS OF GLOBALIZATION OF CLINICAL TRIALS:

The significant benefits of foreign clinical trials include the ability to enable globalized medical product discovery and development, expand diversity of the test subject pool, shorten drug development timelines and less litigious and, importantly, to test patients that are naive to treatments not found in third world countries.

BARRIERS TO CONDUCTING CLINICAL TRIALS:

Lack of financial and human capacity. Financial and human capital barriers were reported across all articles.
Ethical and regulatory system obstacles.
Lack of research environment.
Operational barriers.
Competing demands.

IMPORTANCE OF GLOBAL CLINICAL TRIALS:

Clinical trials are needed globally to reduce disease burdens by helping developing safe and effective new therapies and vaccines. These solutions may be for non-communicable diseases like cancer and diabetes, or, as is especially needed in the poorest regions of the world, infectious disease.

RISKS IN GLOBAL CLINICAL TRIALS:

Most clinical trials pose the risk of minor discomfort, which often lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have experienced serious or life-threatening complications resulting from their participation in trials of experimental treatments.

The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.

In clinical trials that compare a new product or therapy with another that already exists, researchers try to determine whether the new one is at least as good as the existing one. In some studies, you may receive a placebo. Comparing a new product with a placebo can be the fastest and most reliable way to show the new product’s effectiveness.

However, placebos are not used if you would be put at risk — particularly in the study of treatments for serious illnesses — by not having effective therapy. You will be told if placebos are used in the study before you enter a trial.

You can learn about the risks and benefits of any clinical trial and how your rights are protected before you agree to take part in the trial. A member of the research team will explain the study and answer any questions you have about the study. A member of the research team will also ask you to consider and sign an informed consent document, which will describe in detail the specific risks associated with a research protocol. Before deciding to participate, carefully consider risks and possible benefits. You can also talk with your doctor about specific clinical trials you are interested in.

POST –MARKETING STUDIES:

To Study the effects of drug after entered into the market there were several methods used.

OBJECTIVES:

To quantify potential or identified risk.
To provide evidence about absence of risk.
To measure the effectiveness of risk minimisation activity.
To assess pattern of drug utilisation that add knowledge on the safety of the medicinal product.
To evaluate risk of medicinal product used in patient populations for which safety information is limited or missing.

IMPORTANCE OF THE PMS:

The monitoring of drugs after their approval has become necessary for many reasons.

The benefit/risk balance of a medicinal product cannot be fully identified until after a drug in the market and has been used by large, diverse group of patient’s overtime.

Clinical trials conducted before approval may be too small, too short, based on surrogate endpoints to detect all possible risk and efficacy with it.

REFFERENCE: