One of the most important and challenging parts of a clinical trial is finding participants who are willing to volunteer to test out a new treatment. Before a clinical trial begins, researchers have a duty to ensure that potential participants have all the information they need to give their informed consent. Past research has shown that potential participants who have a greater understanding of the clinical trial process are more likely to join a clinical trial.
When speaking to potential participants, researchers must explain the disease/condition at the centre of the study, the current course of effective treatment, present options represented by a clinical trial and ensure that participants are aware of what is involved in each step before moving to the next one.
It’s important that potential participants know how the trial intervention differs from the available treatments already on the public market.
Once a clinical trial site has been found and the medical professionals and researchers have been selected, it’s time to recruit participants. A detailed recruitment strategy should be developed in accordance with the research question.
Some of the important methods to recruit participants include:
- Health care providers network: Put together relevant materials specifically for healthcare providers and build a network of local doctors and hospitals who can help to promote the clinical trial.
- Social media: The most effective way to quickly reach a large number of people with flexibility in terms of spend, and the availability to target certain audiences.
- Search engine marketing (SEM): Geo-targeted search engine marketing (SEM) or pay-per-click (PPC) campaigns allow patients to find information
- on the clinical trial when they do a Google search for clinical trials in their area.
- Connect with nonprofit organisations: Work with nonprofit organisations who have contact with advocacy agencies who can help recruit participants. People are more likely to trust information about trials when it comes from nonprofit companies.
Important Factors to Consider
Put Participants First
The recruitment strategy will be most effective if the trial researchers and coordinators show respect towards potential participants. Understand what participants want and reflect that in the endpoints and the clinical trial design.
Participants might find it a challenge to take part in a trial due to difficulty in finding childcare, the inability to take time off work, or problems getting to the trial site. Trial coordinators should take this into consideration and relax the appointment schedule (when possible), or even offer to pay for parking fees, public transport or a hotel. This shows potential participants that the clinical trial coordinators are willing to listen to them and their needs.
Once the trial begins, participant retention can become an issue. Two ways to help with participant retention are:
- Keeping participants informed: Let participants know that they can receive regular emails and text messages which keep them informed of any updates, upcoming appointments and how to prepare for them.
- Emphasis benefits: Regularly remind participants about the benefits of taking part in the clinical trial, and the important role they play in helping to make effective new treatments available to patients.
Once the clinical trial is over, make participants feel appreciated by thanking them for their valuable time. If participants feel valued, they’re more likely to take part in future studies, or recommend them to other people.
Do Your Research (Clinical Trial Sites)
Clinical trials need a testing site where participants can go to take part in the various tests and receive the treatment. It is important to find facilities that have participated in clinical trials before and have the necessary equipment available. Facilities should also be located in close proximity to an airport for interstate or international participants and should also have hotels and restaurants nearby. They need to have good accessibility with good parking and local public transport.
Clinical Trial Design & Feasibility
People are not likely to join a clinical trial if they don’t have a clear understanding of what it’s about. The design needs to emphasise the benefits to patients, the health care system and to the wider public.
Before beginning the clinical trial, a screening trial is usually held by the researchers, which gives an indication of any potential problems that might occur in the real study.
It’s also crucial to investigate the feasibility of clinical trial sites to ensure:
- That they have a high standard of medical care.
- That they have the infrastructure and facilities available to support proper study conduct.
- That site investigators are willing to comply with the study protocol and procedures.
Above all, clinical trials should be ethical and meet the requirements of the regulatory groups and the Human Research Ethics Committee (HRECs).
Participants want to know they’re volunteering in a clinical trial that has high standards.
Inclusion & Exclusion Criteria
An inclusion/exclusion criteria is a list of guidelines which help clinical trial coordinators and researchers decide who can take part in the clinical trial.
- Inclusion criteria: Criteria that has to be met before participants can take part in a clinical trial.
- Exclusion criteria: Criteria that prevents people from taking part in a clinical trial.
The criteria is usually based on age, gender, stage of disease, past treatment and other medical conditions.
Sometimes participants aren’t eligible to take part in a clinical trial as they don’t have the specific condition needed to test the treatment/intervention. They may also be the wrong age or gender (for gender specific clinical trials for prostate cancer or menopause).
How Participants Get Approved for Clinical Trials
If participants are interested in taking part in a clinical trial, they must first ensure that they tick all the inclusion criterias. They may also be asked to get a blood test so that the researchers have a better understanding of their health before they begin the trial.
All participants must have a clear and thorough understanding of what is expected of them during a clinical trial. They must also be aware that their role is purely voluntary and that they can pull out at any time.
After giving their informed consent (their permission to take part in a clinical trial after they have been given clear and in-depth information about what is involved and any possible risks that may occur), and once they have met with clinical trial coordinators, they can then be accepted into a clinical trial