The Life of a Drug: Clinical Trials and their Importance

By Angel Maria Siji, 11th December, 2022

Source: “Drug Testing.” PHARMA & BIOPHARMA, Bruker , 26 Jan. 2021, www.bruker.com/en/applications/pharma/counterfeit-medicine.html.

ABSTRACT

Most of us would have consumed pharmaceutical drugs during different periods of our lives. From medicinal prescriptions taken for a simple common cold to pain killers for your endless headaches, these seemingly magical remedies have long been an important part of human history. Today, a broad spectrum of drugs, both natural and synthetic, exist. But how did the man realise just how useful a tablet of aspirin could be? And how were we sure these drugs didn’t come with potentially life-threatening risks? For this, we have clinical trials.

Clinical Trails – What are they?

Clinical trials are studies designed to test any kind of medical treatment aimed at diagnosing, treating, and preventing health conditions. Some are done to check a drug’s possible side effects and risks while others check effectiveness.

Regulatory bodies like the FDA (Food and Drug Administration) in the U.S. are responsible for ensuring pharmaceutical products meet certain quality standards before they can be released. The first step in the life of a drug right after its discovery is pre-clinical research.

Pre-clinical Screening

Before the actual clinical trials, researchers need to ensure the safety/toxicity of the drug for human trials. These may include:

· Cell studies: Drugs are tested on petri-dish or test-tube-grown cells.

· Animal studies: Live animals are treated with the drug and monitored.

Drug developers are then able to determine the drug’s geno-toxicity, the ability of a compound to damage genetic material and affect metabolic processes in a cell.

Despite all the data obtained from pre-clinical studies, researchers need to consider many other factors before clinical studies. For example, a treatment that works on mice might not work on humans or may produce side effects that didn’t show up in the mice. But if the completed pre-clinical studies show promising results, the FDA will allow further tests conducted on human volunteers.

Human Clinical Experimentation and Phases

Historically, drug-testing only involved Caucasian males, causing uncertainties about the drug’s validity in those from other ethnicities. This was changed in 1993 after Congress passed the National Institutes of Health Revitalisation Act, allowing women and people of other races to be included in such research.

Source: “Clinical Phases for Drug Testing .” CLINICAL TRIALS PART 3 – PHASES OF CLINICAL TRIALS, 26 Aug. 2021, acromegalysupport.com/phases-of-clinical-trials/.

Clinical trials are typically broken down into 4 phases, each designed for different purposes:

PHASE 1:

This phase, conducted on a small group of people, allows developers to determine how high a dosage can be given safely without resulting in side effects.

PHASE 2:

The drug is given to a larger group to understand its effectiveness. Volunteers are also chosen more specifically. For example, a drug may be tested to see if it works on certain types of cancer.

PHASE 3:

The new drug treatment is compared against the current standard treatment to see which is safer and more effective.

PHASE 4:

After being released into the market, the drug will be watched for a longer period. Any effects associated with long-term use are monitored.

Core Ethical Principles

It is important to consider the ethics of such trials involving human subjects. Firstly, patients should be treated as independent individuals with decision-making skills. This is called autonomy and is an integral component of respect for patients. Another key principle is informed consent where patient participation is voluntary, without coercion. The principle of beneficence also requires health providers to protect subjects from any harm. These and many other ethical principles ensure the well-fare and integrity of volunteers as without them, we would never have recognised the risks a drug presented or, on the other hand, the true potential of drugs present today.

References

1. https://www.pfizer.com/news/articles/how_your_medicines_are_put_to_the_test

2. https://www.cfr.org/backgrounder/what-fdas-role-public-health

3. https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know/phases-of-clinical-trials.html

4. https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials

5. https://www.elsevier.com/__data/assets/pdf_file/0003/1104168/original-McCuistion-Ch-1.pdf

6. https://www.fda.gov/drugs/development-approval-process-drugs#FDA

7. https://blog.intelec.ai/post/cellular-image-classification/

8. https://www.profil.com/knowledge-center/trial-stages

9. https://www.bruker.com/en/applications/detection-and--environmental/forensics/forensic-drug-analysis.html