Generally speaking, pre-marketing clinical trials of new drugs are divided into three stages. Phase I is performed in healthy subjects (tumor drugs are based on tumor patients); The second phase adopts various forms, including randomized, double-blind and controlled clinical trials. In the third stage, the ideal dosage regimen is determined for different patient groups.
When it comes to clinical trials, many people mistakenly think that it is dangerous and terrible to participate in clinical trials of new drugs. Actually, this is a wrong concept.
1. Why are clinical trials not terrible?
1. The first principle of clinical trials is to protect the rights and interests and safety of the subjects. In the course of the experiment, once there is a situation that may endanger the interests of the subjects, you can apply for stopping, and the rights and safety of the subjects are the most important.
2. Clinical trials of all drugs must be approved by National Medical Products Administration.
3. The state stipulates that clinical trials must have sufficient scientific basis and methods to be carried out.
Second, there are four advantages to participating in clinical trials of new drugs.
1, free of charge, reducing family burden: most clinical trials are free, and patients receiving new drugs may recover or reduce their illness during clinical trial treatment, which can reduce family burden.
2. The latest treatment methods in the field: new drugs usually represent the latest trend in the treatment of such diseases, and patients who participate in clinical trials of new drugs can better understand the latest progress and level of their own diseases.
3. Better treatment scheme and drugs: The new drug being developed may be more effective than the current standard treatment scheme, and patients participating in clinical trials of new drugs will be the first beneficiaries of this drug.
4. Get more careful care from doctors: Patients who participate in clinical trials of new drugs will get better clinical care than ordinary patients and attract more attention from doctors than ordinary patients.
3. Is it risky to participate in clinical trials of new drugs?
Participating in clinical trials of new drugs is not only beneficial, but sometimes there may be hidden risks.
1. Possible side effects: Although the probability is very low, it does not rule out that some serious or even life-threatening side effects may occur.
2. It may aggravate the condition after it is ineffective: the new drug treatment may not be 100% effective, and patients who participate in clinical trials of new drugs will generally stop the original treatment scheme, which may aggravate the condition or accelerate the progress of the disease.
3. Need to spend more time: Participating in clinical trials of new drugs is more complicated than routine treatment and requires more time and energy.
In short, participating in clinical trials of new drugs has advantages and disadvantages, but the advantages outweigh the disadvantages for patients. For example, clinical trials in COVID-19 have treated and cured many critically ill patients.
But for healthy people, participating in clinical trials of new drugs may bring unpredictable risks and may affect their own health. For the collective, it is of great significance for healthy people to participate in routine clinical trials of new drugs. The development and marketing of new drugs need the participation of healthy people. Without the participation of healthy people, drugs for treating COVID-19's disease cannot be successfully marketed and applied in clinic. Healthy people participated in clinical trials and made great contributions to medical and health undertakings.