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In the 16th century in the West, James Lind's "scurvy clinical trial" opened the precedent of modern clinical trials; In the East, Shennong, who tasted hundreds of herbs, can be described as the originator
of clinical trial methodology.
After thousands of years, the role of clinical trials has never changed, it is a spark, it is a seed, it carries the hope
of making more effective and safer drugs available to more patients in the future.
IQVIA and Shanghai Medical Clinical Research Center initiated and filmed a series of clinical trial short films "Restart Life", which lasted one year and traveled to many places, through the lens, we recorded the true stories of
three patients.
It is hoped that while popularizing science clinical trials, their "restart life" can bring strength to more people
.
"My father left when I was very young, he didn't leave me beautiful prose poems, but he left me
the cancer gene.
"
This prose poem written by Cheng Yi, a girl from Hubei, made many people who read it burst into tears
.
Young Cheng Yi should have enjoyed a simple and beautiful life, but everything came to an abrupt end
after being diagnosed with descending colon adenocarcinoma in 2019.
after being diagnosed with descending colon adenocarcinoma in 2019.
Cheng Yi underwent four surgeries to remove the tumor and treat related complications, but the tumor is still growing
wildly.
Fate "left a window"
for this girl who originally had only half a year left to live.
The doctor assessed that Cheng Yi may be suitable for a clinical trial
of immunotherapy.
After understanding the clinical trial, including the entire trial process, benefits and risks, Cheng Yi signed the informed consent form, and finally passed the strict screening and formally participated in the
clinical trial.
Cheng Yi said that after participating in clinical trials, "this life was won by herself", and her desire and persistence for life ushered in a turning point
for her.
Cheng Yi is fortunate that her participation in clinical trials has basically made all her tumors disappear, and her life is slowly on track - upgrading her education and returning to work
.
If life lacks a little luck, then a little more courage, clinical trials have saved Cheng Yi's life, and also helped her restart her unfinished journey and continue to write prose poems
in life.
Drug Clinical Trials (Clinical
Trial), means any systematic study of a drug conducted in patients or healthy volunteers with the intention of discovering or verifying the clinical, pharmacological and other pharmacodynamic effects, adverse effects, and/or absorption, distribution, metabolism and excretion of the test drug to determine the efficacy and safety
of the test drug.
Clinical trials have both benefits and risks, so investigators need to initially assess the expected benefits and possible risks
before enrollment.
Benefits are any expected beneficial effects associated with the drug on the target population, such as elimination of existing disease states (e.
g.
, cure of tuberculosis), prevention of negative health consequences (e.
g.
, prevention of cardiovascular and cerebrovascular events), improved ease of administration or adherence, etc
.
Risk refers to drug-related adverse events and other adverse effects, such as adverse effects
on patient health, public health, or the environment.
Benefit risk assessment requires determining whether the expected benefits of the investigational drug outweigh the potential risks, and is an important step
in drug clinical development, market registration and post-market regulatory decisions throughout the life cycle of the drug.
Liu Yi's father died of lung cancer at an early age, and her mother, Li Yingqiong, who was in her 60s, was also diagnosed with lymphoma
.
The news of this diagnosis was a severe blow
to this not wealthy family.
Liu Yi can no longer bear the weight
of "losing his mother".
"With my mother here, I won't feel so lonely in my life", this is Liu Yi's soft but firm thought
.
After carefully studying the early safety data, admission criteria and management practices of the experimental drug, Liu Yi summoned a meeting of the family to discuss the feasibility
of the mother receiving the clinical trial.
Finally, after careful consideration by her family and strict screening by researchers, her mother Li Yingqiong enrolled in the clinical trial
.
After the treatment of clinical trial drugs, Li Yingqiong's body gradually improved
.
Now she can not only entertain her grandson, but also become the "brightest star of square dance"
.
When he came home from work, Liu Yi could eat his mother's cooking again, which he thought was the most cherished thing
in ordinary life.
in ordinary life.
In clinical trials, defining criteria for the selection of subjects is the first step
in conducting research.
Develop inclusion criteria or exclusion criteria
criteria) is to identify a specific group of people
to use for the study.
Inclusion criteria are to determine the target population based on the research question and research efficiency; Common inclusion criteria include disease characteristics, demographic features, and pre-enrollment disease status
.
The exclusion criteria were the population
that could not participate in the study as defined by the study question.
The exclusion criteria are often people with a potential high risk and a high probability of loss to follow-up
.
It is important to note that the inclusion criteria should produce a sufficient number of subjects and may be broadened accordingly to maximize
the ease of recruitment.
For example, if sufficient clinical data can confirm that the incidence of adverse drug reactions of interest, such as cardiovascular events, is extremely low, it is often necessary to recruit such high-risk groups (eg, patients with type 2 diabetes with one or more cardiovascular risk factors).
Exclusion criteria should be cautious, as unnecessary exclusions may result in the inability to recruit a sufficient number of participants, weaken the scalability of study results, and increase the complexity and cost
of recruitment.
Strict implementation of reasonable "discharge criteria" is the premise to ensure the scientific and smooth development of clinical trials, and it is also one of the standards and measures to minimize risks and ensure the safety of
patients participating in clinical trials.
If the patient does not meet the relevant conditions, the investigator may require some patients to actively adjust one of their own indicators, and they can participate after passing the qualification, and some patients cannot participate in the clinical trial if they do not meet a certain requirement of the clinical trial
and cannot be improved by conditioning.
Migraines have plagued Jiang Yuguang for more than ten years
.
From the initial sudden pain to seventeen or eight attacks per month, although it is not fatal, this chronic disease is like walking in a minefield for Jiang Yuguang, and it may explode at any time, which affects both work status and life mood
.
Painkillers treat the symptoms but not the root cause
.
What annoyed Jiang Yuguang even more was that from time to time he had headache attacks, and even became a "wolf" among his family and work partners, Jiang Yuguang gradually became anxious and depressed, and seemed to see no hope
of getting rid of his distress.
After accidentally learning about the clinical trial of a new migraine drug, Jiang Yuguang applied to join the clinical trial
with a glimmer of hope.
In the process of medication, the design ratio of experimental drugs to placebo, as well as details such as the trial process, made Jiang Yuguang realize the scientific and rigorous nature of clinical trial design standards, and also made him have more trust
in the treatment process.
After receiving the clinical trial, Jiang Yuguang's migraine attacks decreased significantly, and he felt that he could finally look forward to the day
when he waved goodbye to this "old friend".
Randomized controlled trials
TRAIL, RCT) is recognized as the gold standard for evaluating the efficacy and safety of a drug or treatment modality, and is the primary recommended evidence in the guidelines, including standard care or placebo
.
A placebo simulates the appearance, size, color, dosage form, weight, and taste of the test drug, but cannot contain the active ingredient
of the test drug.
In clinical trials, placebo is primarily used to compare
efficacy and adverse effects with the test drug.
Clinical trials with placebo-controlled trials are usually double-blind, meaning that the observer and the observed person do not know throughout the trial whether the subject is receiving the investigational drug or placebo
.
The two are usually randomized in a 1:1 ratio, but it cannot be ruled out that in trials with greater potential efficacy, the investigational drug will be designed to be 2:1 or 3:1
compared with placebo.
These placebo-controlled clinical trial designs will be conducted
after rigorous scientific inferences and ethics committee review and approval.
The main purpose of setting up placebo control is to overcome the bias of psychological and other factors, minimize the subjective expectations of patients and doctors, and eliminate the impact of disease development, so as to set off the true efficacy and safety
of the test drug.
It is important to note that placebo-controlled clinical trials are often used in patients with mild or functional disease, where the use of placebo can be used to determine whether the drug itself has a positive therapeutic effect
.
In addition, placebo may be chosen if the target disease is not effectively treated or is self-limited
.
Conclusion
ConclusionAcross the country and even around the world, there are many patients like the three protagonists in the film, who have fought or are tenaciously fighting the disease
.
In 2021, the number of clinical trials worldwide reached a record high, with 84 new active substances on the market worldwide, a record
number and the breadth of new drug applications.
In 2021, about 5,500 clinical trials were initiated worldwide, with a total enrollment of more than 2 million patients, of which the number of oncology clinical trials initiated increased by 70% compared with 2015, with a total enrollment of nearly 300,000 subjects
.
The number of drug clinical trial registrations in China exceeded 3,300 for the first time, and the clinical trials of chemical drugs and biological products were mainly
anti-tumor drugs.
The direct purpose of clinical trials is to verify or prove a certain characteristic of a drug, but the fundamental purpose is always to improve the level of medical services, promote rational drug use, and improve the quality of treatment and quality of
life of patients.
From West to East, from James Lind to Shennong, clinical trials are a magnificent epic spanning thousands of years
.
The spark of the spark, the cohesion can be burned; Chunhua Qiushi, the same road with a red heart; Let more people "restart a better life"
.
For the advancement of human health, we and you have been on the road
.
.
