I got asked a great question by a viewer who is considering to participate in a clinical trial. He asked me what phase of trial would be best for him. For those that want to learn more about the various phases of clinical trials, I recently wrote about it here.
My answer is addressed in the video, but basically if a clinical trial gets to Phase 3, it is often called a pivotal trial. These studies usually recruit a large number of study participants, usually between 500 and 2500 total participants. The dose and the majority of side effects are believed to have been determined by this point, so the main objective is to determine whether the drug works in comparison to a placebo (sugar pill). Safety and side effects are still closely observed as well. These studies usually occur in outpatient settings and involve many study visits (between 10-30 at times). If the drug proves to have efficacy (does it actually work?) over placebo, or a comparable drug that is already approved and on the market, the drug company will file an NDA (New Drug Application) for FDA review. The FDA may take as long as 1 year to make a decision on whether the drug will be approved, or whether even more trials are needed to determine safety or efficacy. At this point, labeling issues (what information appears on the bottle, and what the drug company can claim regarding the drug) are addressed.
Posts tagged study participant
In this video, we answer a viewer question regarding what happens if someone joins a clinical trial and ends up getting a placebo (non-active sugar pill) while in the study. This is one of the most common questions that trial participants ask, and we figured it would make a great topic for our blog. Let us know if you found this to be helpful!
How To Answer Volunteers’ Questions
It’s only natural that volunteers who are preparing to take part in their first clinical trial will have many questions about what will happen on the trial and who they can expect to meet. The purpose of this article is to give you some guidance on answering their queries by providing background information on the types of healthcare staff volunteers are likely to encounter on their journey. Of course, the exact number of staff and their roles may vary a little from trial to trial, but generally speaking, these are the staff members volunteers are likely to meet along the way.
The very first contact volunteers may have with the research team may well be by telephone. In this case, it’s likely that they will speak to a recruitment co-ordinator, who will ask some basic questions about their health and share some information about the trial.
The volunteer’s first visit to the clinical trial facility will be a screening visit. Here they will meet a doctor or a member of his or her team (this could be an investigator or clinical research co-ordinator) whose first job will be to take them through the ‘informed consent’ procedure. (The purpose of this is for them to give the volunteer detailed information about the trial and provide an opportunity to ask questions.)
A Testing Time
Then, depending on the exact nature of the trial, the volunteer will have a number of tests, typically blood draws, urine samples, vital signs and an ECG. These will be carried out by a research nurse, who will be the volunteer’s point of contact throughout the trial and who can help answer any questions they might have along the way. The volunteer may also have their height and weight taken, or undergo hearing or vision tests or even psychological tests.
A Picture Of Health
The volunteer will also be asked to complete a survey to give a picture of their overall health and medical history. It may also contain questions relating to their past medical history, and it’s important to emphasize here that although some questions may seem rather personal in nature, for example whether they have ever been on any alcohol abuse treatment programs or suffered from a mental illness, it really is for their own benefit that they answer them honestly. The answers will then be analyzed by a healthcare professional, along with the results of the tests. From these, the volunteer’s suitability for the trial will be decided.
The Next Step
If the volunteer gets through the initial screening process and is happy with the information they’ve received, it’s time for the next step – the trial itself. There are many different members of a clinical research team besides the doctors and nurses the volunteer may already have met. Their health will be monitored closely throughout the trial, so without doubt they will have plenty of contact with their research nurse or medical assistants who may carry out some basic tests.
Often a clinical trials officer will give the volunteer information about the trial as it progresses, respond to any queries they may have and organize their treatment plan.
Depending on the scope of the trial, the volunteer may also come across dieticians, psychologists, radiographers (people who take x-rays), physiotherapists, occupational therapists, pharmacists and social workers.
The volunteer may already be aware that some trials require a stay in a research unit as if they are a patient in hospital, and some allow them to take the drug (or placebo) at home. If it’s the latter, then it’s likely that they will just visit the unit or doctor’s office for check-up appointments where basic monitoring will take place.
Once the trial is over, the research team analyzes the data and reports their findings to scientific journals and meetings. Usually a volunteer’s contact with the research team ends here, as it’s not normal practice to continue to take the medication after the end of the trial.
A Small Cog In A Big Machine
There are, of course, many people who work behind the scenes on clinical trials who volunteers may not get the chance to meet. There’s the clinical investigator who oversees the entire research project, the project managers, statisticians, administration staff, and even the porters and cleaners who work on the unit. Although volunteers may only come into contact with a fraction of these people, they may find it good to know that they are not alone in helping to further medical research. Advise them that they should think of themselves as a small but vital cog in a big machine helping to provide better treatment for generations to come.
We receive tons of questions here at The Clinical Trials Guru and today’s video is a direct response to a viewer’s question regarding what happens at your first clinical trial visit, also known as a screening visit. In this video I refer to a specific chapter from my ebook which you can get for free here. Anyways, please let me know if this walk through was helpful at all in relieving any of your anxiety regarding what you can expect at your first clinical trial study visit.