What Is The Importance Of Medical Research Studies?

 

What do you know of medical research studies? Without them we may not have the medicine, vitamins and surgical procedures we rely on today. Clinical drug development relies on the consent and active participation of volunteers to ensure its products are safe for the general public to use. However, medical research studies need to follow a rigorous set of guidelines to remain as ethical and reliable as possible.

What Are Phase 1 Trials?

Medical research studies are separated into multiple trials to judge the gradual effect a given product or form of medication has on the participants. Here researchers will test an experimental drug or treatment on a relatively small group of people, as low as 20 and as high as 80, for the first time. This is done to assess everything from safety to certain side effects in order to craft the best product possible.

What Are Phase 2 Trials?

Following a phase 1 clinical trial, a phase 2 trial continues down a similar path. Here the experimental drug or treatment will be administered to a larger group of people, as low as 100 and as high as 300, to determine similar results. This will then be followed by phase 3 trials, generally the final stage.

What Are Phase 3 Trials?

After phase 1 and phase 2 we have phase 3 trials and their role in creating the final product. The drug or treatment will be given to the largest group of people possible, as low as 1,000 and as high as 3,000, in order to gain a more complete overview of side-effects, interactions and overall results. This information will later be compared with standard or equivalent treatments, allowing researchers to collect vital information and apply it effectively.

What Are Phase 4 Trials?

The final stage is phase 4, then allowing the clinical trial team to submit a New Drug Application (shortened to NDA) for approval to go out on the mass market. Out of the 5,000 to 10,000 drugs that enter the RandD every year, only 250 or so will make it to pre-clinical trial testing. On average, only five will actually reach FDA approval. Without ongoing clinical drug development and an effective clinical study, the vast majority of products put out today would be unfit for human consumption.

What Are Medical Guidelines?

Medical malpractice is a serious issue, one that is actively worked against in many fields through the support of constantly updating laws involving consent and proper administration. Informed consent is so important that the 9th revision of the American Psychological Association’s Ethical Code has its own section on the subject. If researchers plan on using children (anyone below the age of 18), they are legally required to obtain consent from the parent or legal guardian of the child.

How Effective Are Medical Research Studies?

A recent survey concerning clinical trials in the United States saw an overwhelming majority of respondents having never participated in a clinical trial of any sort. Another study saw around 46% agreeing that taking part in clinical trials is as valuable to the health care system as donating blood. Ethical and consensual medical research studies are the backbone of the medical industry, allowing doctors and scientists to distribute the most effective medicine and treatment processes possible.