No matter if clinical trials are sponsored by the industry or government, they have the goal to improve or discover completely new ways for treating diseases. But most of all, researches are capable of dictating the advancement of medicine and healthcare.
There are millions of volunteers who realize how important for the sector and humans health trials are and decide to take part in such investigations. However, prior to their participation, every volunteer has the right to know what to expect from procedures of this kind. Being well-informed, then, plays a huge role here. Participants must require information about important contacts, the initial purpose of the study, its duration, included processes, treatment phases, potential risks and benefits. In addition to this, people who want to take part in trials should also understand the requirements for participation or who is or is not eligible to participate. And because study volunteers are not bound to any contracts, they can withdraw at any time.
To help you better understand what clinical studies are, we list several fundamental questions to ask before jumping to any conclusions or making decisions.
1. What are clinical trials?
In essence, trials represent research studies which are designed to determine if new biomedical or behavioral interventions are efficient and safe. Each study focuses on providing adequate answers to scientific questions and aims at offering better methods for diagnosing, treating or preventing certain medical conditions. Clinical trials are usually performed on human subjects. Investigators observe how people react to their treatment and look at possible side effects.
2. What are the benefits of participating in a clinical trial?
Well-designed and well-performed clinical trials can bring a lot of advantages to participants. For example, there are research studies which offer monetary compensation to people for their participation and dedication. Other benefits for participants include:
- Gaining access to new research treatments and interventions which are still not available to the public
- Having more active role in your own healthcare
- Getting quality medical care from professionals at leading healthcare facilities and hospitals
- Helping future generations now and in the future by adding value and contributing to various research practices
3. What are the risks of participating in a clinical trial?
Participating in clinical trials may offer several benefits but it is important to know that there are potential risks too.
- There may be anticipated or unanticipated side effects which may be serious or even life-threatening
- The experimental treatment may not be effective
- The study may require a lot of traveling, a lot of time spent at hospitals or getting more treatments
- Study costs may be covered just partially by patient’s insurance
4. Who is eligible to participate?
Every clinical trial has its gridlines and requirement about who is allowed to participate and who is not. There are specific factors which allow or do not allow someone to take part in a research. They include: age, gender, type of a disease, stage of a disease, previous or current treatment details, recent participation in other trial and others. The factors that enable a person to participate are known as “inclusion criteria” or “eligibility criteria. The factors that define someone as ineligible are called “exclusion criteria.”
5. What is informed consent?
There is the informed consent document and informed consent process. Prior to agreeing to participate and before the start of any clinical study, volunteers are asked to give their official consent to receive a treatment. By giving their consent, patients indicate that they accept the conditions and understand what will happen during the trial.
- Informed consent document – It provides a summary of the study. This summary points out what the purpose of the study is, the treatment procedures, schedules, risks, benefits, and also specifies about any other alternative treatments. Additionally, the informed consent document explains the rights of participants.
- Informed consent process – It offers additional information, explanations and specifications to participants throughout the course of the study. Such details help people make educated and well-informed decisions whether to start, continue or withdraw from a trial.
6. What is a protocol?
A protocol is a carefully designed and prepared study plan and all studies revolve around it. Every protocol outlines the requirements for participation; the schedule of tests, treatments, medications, and dosages; and the duration of the research.
If you are interested in the topic of clinical trial protocols, you may like to check out our Clinical Trial Protocol FREE training as well as our In-house accredited Clinical Trial Protocol training.
7. Are patient’s safety and privacy protected?
Patient’s safety and privacy are always prioritized. The ethical and legal codes that apply to different medical practices also apply to research studies and they make sure that the rights of subjects involved in a trial are safeguarded.
All in all, being well-informed before deciding to take part in a trial is of a great importance. It helps people understand the focus of the trial much better and prepares them for what to expect next.