Are Clinical Trials Safe? 5 things To Know Before You Sign Up

Clinical trials can be a good way of making a few extra dollars. However, many people wonder if the trials are safe, so they are hesitant to participate. Safety can vary between trials depending on the clinic that is holding the trial, the qualification of the staff, what the trial is testing, what medication is used, etc. However, there are a few things to know about clinical trials in general before you commit. It is important to thoroughly research the trial you intend to participate in, but here are a few things you should know before signing up for a clinical trial anywhere.

You’re Not the First Test

Clinical trials are made safer by extensive research prior to administration to humans as well as animal trials on animals that have a similar genetic makeup to humans. Researchers are extremely confident of the drug’s efficacy and lack of serious side effects before they begin conducting clinical trials on humans. If any of your findings suggest that you are the first group to try a new drug or treatment, find out what that really means. Try to find out how extensively the clinic has tested the treatments before they plan to test them out on you.

Liability is High

The value of human lives is high for researchers, and any problems with the clinical trials could mean millions of dollars in payouts to the participants. So you can be sure that researchers will take all of the safeguards necessary to prevent possible injury or side effects. Because of the liability involved in clinical trials, they are not just thrown together (for the most part.) They take careful planning and are meant to benefit people, not put human lives in danger. Because of liability issues, the clinic you choose should have a highly skilled staff of individuals who know what they are doing. They will use a high grade of medical devices, even for small things like syringes, a Luer Lock, needles, and other instruments. Any legitimate clinical trial will have a professional staff, adequate equipment, and high confidence in the success of the trial and safety of the patients.

You Will Be Monitored Carefully

Researchers will be sure to monitor their clinical trial participants very carefully for any signs that the drug is having an unintended effect. Your health, vitals, experiences, and symptoms will be of great importance. Any signs of trouble will mean that the trials will be stopped, and the symptoms will be treated carefully. Those holding the trial will be sure to give you explicit instructions of what to do if you experience any abnormal symptoms, and prepare you for anything that could go wrong. They should also provide you with contact information you can use either for an urgent situation, or just for any questions or concerns you may have. They will want to communicate with you as thoroughly and frequently as possible, not only to monitor your status, but to make sure that nothing is out of the ordinary or endangering your life in any way.

You Are Not Obligated to Continue

If at any time during a trial you feel that you would not like to continue, you are able to quit taking the medication and end the trial. So you can feel safe in knowing that you will not be obligated to continue a trial if you think that you may be experiencing negative symptoms from the medication. However, your health will still be monitored for a certain period, even if you choose to end the trial. In most cases, you will still get paid and won’t be penalized for ending the trial early. The clinic will want you to end the trial if it is putting your life and health at risk, so you will likely still receive compensation for the part of the trial that you participated in.

There are Various Levels of Safety

As mentioned before, the level of safety of the test depends on many factors. For instance, it could be considered a “safer” trial depending on how many trials have been conducted with the medication before. If you are in the fourth round of human trials, and the first three have gone successfully, then you can be fairly confident that you will be safe. It will also depend on what the trial is testing, like what diseases or body parts are the main focus of the trial. This is where your judgment comes into play. It is up to you to do the research necessary to decide if a particular trial is right for you. After weighing the pros and cons of a study, you can decide if it is worth your time, the amount of money offered, and the risk to your personal health.

 

Clinical trials do have their risks, but companies and researchers have a lot of interest in making sure that the drugs are safe before they administer them to people. The public backlash, human cost, and moral concerns make it certain that the clinical trials will be well monitored. Most clinical trials are very safe, and there is a lot of effort put into making the trials as safe as possible.

Categories: clinical, Safe, trial

Could Early Treatment of HIV Avoid it Being Transmitted?

As well as being one of the biggest threats to sexual wellbeing, HIV is one of the most serious threats to the emotional and psychological wellness of those affected.

 

This is because once you have become infected, you not only have to live with the condition for the rest of your life, and the worry that it is going to cause the premature ending of your life, but you also have to become aware as a carrier that you are at risk of passing on the disease to others.

 

A large, randomised trial was recently carried out which involved over 1,700 heterosexual couples where one person in the couple had HIV and the other did not. The results of this trial were astounding, and seemed to indicate that early treatment of HIV could avoid it being transmitted sexually.

 

The results showed that the people who took the anti-HIV drugs reduced the risk of transmitted the disease to their partner by a whopping 96% when compared directly to those who did not receive the drugs early.

 

These results were so staggering that lead scientists Dr. Anthony Fauci decided to release the results of the study a good four years before it was scheduled to end, as he felt that the potential benefit of what they had discovered was enormous. All of the participants in the study are now offered the antiretroviral therapy.

 

Another trial was also recently carried out which seemed to indicate that using antiretroviral drugs could possibly be used as a preventative measure against contracting HIV. This trial involved 2,500 HIV negative males in countries where they were at high risk of contracting the disease. Those who took the anti-HIV drugs were found to be between 44 percent and 73 percent less likely to get HIV.

Categories: anti hiv, Disease, drugs, early treatment, HIV, hiv drugs, nbsp, results, treatment, trial

“Trial and Error” in Antidepressant Treatment

Whilst finding the best treatments for depression can often be a process that involves a certain degree of “trial and error”, recent studies have indicated that specific biological markers in the blood can allow doctors to make a more informed decision on which antidepressants will work for patients in their care. According to Carmine Pariante at the King’s College Institute of Psychiatry:

“The study shows that we could use a blood-based test to personalise the treatment of depression”.

The studies have revealed that high-levels of inflammation within the body’s blood can be a pre-determinant of depression, especially for those who do not respond positively to low doses of antidepressants.

In recent years,  the number of people experiencing depression has risen dramatically and the World Health Organisation (WHO) has made the alarming prediction that by 2020, depression will be as common as heart-disease as a form of chronic illness. Whilst there are many antidepressants available, the most common ones being Prozac and Seroxat - it is widely acknowledged that they generally only work for 50% of the patients they are prescribed to, and at this point, pharmaceutical developers are finding it challenging to design similar treatments within the category.

In the study, Pariante’s team have indentified 2 types of bio-markers: ones which can predict future responses to antidepressants, called predictors and ones which are targeted by antidepressants and can change over the course of the treatment - known as targets. During the study the respondents were treated with 2 types of antidepressants: Escitalopram and Notriptyline, and after 8 weeks, the researchers concluded that patients who had high-inflammation and marker-levels were not experiencing any significant improvements in their condition. This suggests that the bio-markers could be used as a means of doctors determining which treatments are effective for patients, before the drug is administered, helping to reduce the often, distressing, “trial and error” aspect of the process.

Categories: Antidepressant, Mental Health, trial