Clinical Trials: Risks, Safety, and Patient Protections

Is it Safe for Me to Participate in a Clinical Trial? Is It Worth the Risk?

Clinical research trials, or studies conducted by research professionals to test the safety and effectiveness of medications or procedures in development, come with some inherent risk.

 

The tests being conducted are just that – tests. This means that at the time of the trial, the researchers don’t fully understand all of the potential effects of the treatment. However, here’s why paid clinical trials may be worth considering.

Only the best make it to trials.

First, only the most promising treatments make it far enough to be in clinical trials with volunteers. Before that, extensive testing and research are done by other means such as in laboratory conditions and simulations.

 

Studies follow strict guidelines set by the FDA.

Second, there are strict rules and guidelines set by the US Food and Drug Administration (FDA).

At the website clinicaltrials.gov, you can learn more about how participants are protected through a process called informed consent — “a process used by researchers to provide potential and enrolled participants with information about a clinical study.

This information helps people decide whether they want to enroll or continue to participate in the study.”

Furthermore, the FDA regularly inspects clinical trial facilities to assure their quality and professionalism.

The need for upfront information.
Finally, it’s important to choose a research facility that has a professional staff that can walk you through every step of the process and whose guidance you feel comfortable with – long before the trial actually starts.

 

Minimizing Risk During the Research Study

Some risks are minimized before the clinical trial ever begins. Before any investigational new drug is tested in the human population, years of work have gone into its validation. Many researchers have tested the effects of the drug on cells in petri dishes in a lab, and after conditions for its use have been optimized, it is tested in animals.

 

Safety, efficacy, and dosage are determined in animals, and many times, they are validated in more than one animal model. Investigators have an idea of what dose levels will be safe and effective in humans, and they have an idea of what side effects they might expect.

When the drug is ready to graduate to human clinical trials, the trial sponsor must submit an Investigational New Drug application to the FDA and the study protocol must be submitted to an Institutional Review Board whose primary role is to ensure participant safety.


In addition to the behind-the-scenes steps to minimize risk, some of the things that protect participants in a research study are more obvious.

The participant needs to understand the risk.


The informed consent document that the participant is required to review and sign should list any specific risks that the investigator considers a possibility. It should also inform the participant that it is possible that there could be additional harms that are completely unanticipated. No participant should ever feel like they were taken advantage of and were subject to being harmed without understanding the risk.


The researchers should make sure that the participant has their contact information and feels welcome to reach out to the study team with any questions or concerns, both about potential risks before agreeing to participate, and actual problems they may encounter while part of the study.
The risk should be minimized to the fullest extent possible.


Study design should reflect the breadth of knowledge about an investigational agent. When studying a drug in humans for the first time, in a phase 1 trial, investigators start with a dose that is much lower than what could safely be used in animals, and they increase the dose very gradually as they see that there are no unacceptable harms to patients.

 

Once a drug is shown to be safe at a certain dose level, it can be given to a larger number of patients with the confidence that it poses them minimal risk, and so in phase 2, 3, and 4 trials, the dose is given to patients reflects what investigators learned was safe in phase 1. Investigators also build on what was learned in earlier phases to find the dose or treatment schedule that is not only safe but most effective in treating the disease. Learn more about the phases of clinical trials here.


Participants are closely monitored. Since there is uncertainty about the incidence and severity of specific side effects that participants might encounter, they are very closely monitored by the study team. This may mean more trips to the clinic, more blood draws, more check-ins with a nurse, or a clinic staff-member who is more responsive when a participant calls with concerns or questions.

 

 

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