A guide to the basics of clinical research trials

Clinical studies whether these are voluntary or Paid Medical Trials such as those operated by https://www.trials4us.co.uk/ongoing-clinical-trials/ let pharmaceutical companies discover whether treatments and medications perform as intended. To do this, research companies screen and enlist human volunteers to take untested medications, use new medical devices or try new treatments. Results from human trials prove a product’s safety and enhance a company’s trustworthiness. Since the results are so important, pharmaceutical companies fund this research.

 

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Pharmaceutical companies cannot perform clinical trials in-house. They hire a contract research organization (CRO) to dispense study medications, collect samples and manage the data. These organizations are third parties, performing research as neutral evaluators. Before researchers give new drugs to study participants, the laboratory makes sure the substance is safe for humans to take. Once deemed safe, human tests can begin and a contract research organization starts gathering volunteers.

Studies need framework

No trial can begin without a goal or intent and a study’s intent determines the best research method. There are two types of studies; observational studies and clinical trials or interventional studies. When researchers need to know if a blood pressure medication works they enlist volunteers and assign them to specific test a medication. In those circumstances volunteers take part in a clinical trial or interventional study. When researchers want to understand how lifestyle impacts heart health, they monitor a group of elderly chess players. This is an observational study and participants are not testing a specific item.

Regardless of the study, study companies have a principal investigator, usually a medical doctor, heading the research. The research team can include other medical doctors, social workers, phlebotomists and nurses. These studies involve a lot of people doing the research, but what about the participants?

Volunteers need protection

Researchers could not keep doing studies without making the experience as tolerable as possible for the participants. Screened and accepted, participants might be at the mercy of mad scientists, but protections are in place. In  the Declaration of Helsinki, The World Medical Association sets forth principles that preserve participants’ right to informed consent, self-determination and respectful treatment.

Clinical studies protect consumer from dangerous drugs while proving medications safe and effective. It takes a new drug six to seven years to get through the clinical trial phase, and that phase has three separate phases. If a new drug succeeds in clinical trials, it goes to the FDA for review.

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