Clinical trials are an essential part of the development of new interventions and tests that will help your patients and may alleviate the symptoms of their disease or condition.
What is a Clinical Trial?
A clinical trial is a scientific study, or an organised test of medicines and new treatment options involving patient and non-patient human volunteers. Clinical trials confirm whether medicines are safe and effective to introduce as new treatments for a disease or condition.
Phases of clinical trials
Clinical trials are conducted in “phases.” Each phase has a different purpose and helps researchers answer different questions.
- Phase I trials: Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
- Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
- Phase III trials: The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- Phase IV trials: After a drug is approved by a Regulator and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.
Why are clinical trials needed?
Clinical trials are necessary to show that the medicine is safe and effective for use in humans. Clinical trials help establish if the medicine being studied will work, what, if any, are the side effects and what the correct dose should be. This helps doctors to decide if the medicine is more effective and/or safer than existing medicines or treatments. They may also provide information about whether the medicine could be effective in treating other illnesses. Without clinical trials, medicines cannot be approved for use in Australia
Clinical trials may also be used to determine whether an existing medicine can be safely and effectively used for other diseases and/or conditions.
How are clinical trials approved?
Before clinical trials can go ahead they need to be approved by independent ethics committees. These ethics committees operate in accordance with the guidelines issued by the National Health and Medical Research Council and ensure that clinical trials conform to the Declaration of Helsinki and to international Good Clinical Practice guidelines.
Who runs a clinical trial?
Each clinical trial is led by a doctor. The clinical trial team includes doctors and nurses as well as pharmacists and other health care professionals. The clinical trial team is responsible for checking the health of the participants at the beginning of the trial, monitoring them during the trial, and staying in touch with them for a period of time after the clinical trial has been completed.
What are the benefits from participation in a clinical trial?
There are several possible advantages of participating in clinical trials. These can include:
- Gaining early access to new medicines not otherwise available;
- Obtaining the clinical trial medicine at no cost, at least during the trial;
- Receiving extensive medical care associated with the clinical trial; and
- Contributing to the development of future lifesaving or life-enhancing treatments.
Participation in clinical trials is not, however, without its downsides.
- Patients participating may experience some side effects from the trial medicine
- The trial medicine may not work for a particular patient;
- A Patient may be placed in the control or reference group and may not receive the trial medicine.
- You may need to visit the hospital or doctors’ room more frequently and/or stay there longer
How can a person participate in a clinical trial?
Before making this important decision, a person must be given a full written plain-language explanation of the clinical trial by a doctor. Only after carefully considering this document should a person provide their written consent to participate. The explanation of the study will include things such as the:
- Eligibility criteria;
- Possible risks and benefits of the new medicine;
- The risks of any side-effects;
- The type, frequency and risks of any medical tests or procedures that may be undertaken as part of the trial; and
- The participant’s rights and responsibilities. Potential participants will be made aware that they can withdraw from a study at any time, without any effect on ongoing medical care and that their involvement is entirely voluntary
The clinical trial will commence when a sufficient number of people have been enrolled to participate in the clinical trial. This may take some time.
What happens if side effects occur from taking a medicine in a clinical trial?
By the time a medicine reaches the clinical trial stage it has already been extensively tested for likely side effects. However, especially with new medicines, there might be additional side effects. It is not possible to predict in advance if any side effects will occur but, if they do, appropriate care will be provided to participants.
What happens with the results from clinical trials?
The results of clinical trials are made available to doctors so that they can make scientifically valid assessments of the benefits and risks of a new medicine for their patients. The results may also be published in medical journals and other relevant publications. In addition, study doctors will be notified of the results of the study as they are made available and so it is recommended that participants keep in touch with their doctor so that they too can be advised of the results. All details of a participant’s treatment are kept confidential even when the results of the study are published. Results of the treatment will be analysed, but confidentiality is assured.
Research principles and guidelines
In Australia, all research involving humans must comply with the principles set out in the following guidelines:
- National Statement on Ethical Conduct in Human Research (2007) — updated March 2014 (National Health and Medical Research Council)
- Australian Code for the Responsible Conduct of Research (developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia)
- Applicable State and territory guidelines.
Clinical trials of medicines and medical devices also must comply with
- Note for guidance on good clinical practice (CMP/ICH/135/95) (Therapeutic Goods Administration)
Clinical trials of medical devices must also comply with
- ISO 14155:2011 Medical devices — Clinical investigation of medical devices for human subjects: Good clinical practice (ISO)
Why talk to your patients about clinical trials?
Clinical trials are an essential part of the development of new interventions and tests that can help your patients and may alleviate the symptoms of their disease or condition.
One of the principal challenges of recruiting clinical trial participants is a lack of awareness, both amongst health care professionals and participants, about clinical trials, their availability and how to participate.
Several studies indicate that increased awareness changes attitudes toward clinical trials, enrolment, and the benefits of participation. For example, the research study entitled Misconceptions and lack of awareness greatly reduce recruitment for cancer clinical trials (See Harris Interactive Survey (2001). Health Care News 1(3).) concluded that:
- 85% of patients were either unaware or unsure that participation in a clinical trial was an option at the time of diagnosis.
- 75% of these patients said they would have been willing to enrol in a trial had they known it was possible.
How to talk to your patients about clinical trials
One role of health care professionals is to provide accurate and balanced information for their patients. The focus of discussions between health care professionals and patients should be to raise awareness of clinical trials and discuss the risks and benefits of participation, rather than to specifically encourage participation in a trial.
The NHMRC website — www.australianclinicaltrials.gov.au — provides support material and information on next steps for patients who are interested in participating in clinical trials.
General principles for talking to your patients
Principle 1 — Good communication between health care consumers and health care professionals has many benefits.
There is evidence that good communication helps to build trusting relationships between consumers and professionals, leads to greater satisfaction for both groups, helps people to take more responsibility for their own health and reduces medical errors and mishaps.
Principle 2 — Health care consumers vary in how much participation in decision making they desire.
Some consumers prefer to make their own decisions about their health care; others prefer to leave the responsibility to a professional. A person’s preferences for involvement in decision making may vary depending on how serious the medical situation is.
Principle 3 — Good communication depends on recognising and meeting the needs of health care consumers.
Factors such as age, gender, health status, education and cultural background can affect communication between consumers and professionals. Recognising the impact of such factors helps to improve communication.
Principle 4 — Perceptions of risks and benefits are complex and priorities may differ between health care consumers and health care professionals.
Perceptions of risks and benefits are shaped by influences such as personal experiences, emotions and education, and thus differ from one person to another. Communicating these perceptions can help consumers and professionals to understand the other’s perspectives and arrive at decisions that meet the needs of the individual consumer.
Principle 5 — Information on risks and benefits needs to be comprehensive and accessible.
Communicating risk in a way that is objective, useful and unbiased means taking into account factors such as emotions, language, images and perceptions, relevance and amount of information, uncertainty and the effects of ‘framing’ information (for example, by portraying it in a positive or negative way).
Principles for talking about clinical trials with your patients
Patients who have been diagnosed with a particular disease or condition may be interested in clinical trials either to better understand and manage their condition or to play a part in improving health care.
You can initiate a discussion about clinical trials to raise awareness and open the possibility of participation or you can answer questions if the patient is already interested.
When speaking with potential participants, you can:
- communicate respect and the importance of the meeting by acknowledging the trauma associated with the diagnosis (if appropriate) and by displaying empathy in response to emotional reactions
- simplify information by avoiding medical jargon and a laundry list of medications and side effects
- summarise information often and repeat important points
- provide a pen and paper for the patient to take notes and write down questions
- invite patients to make comments or ask questions at any time
- encourage patients to share their thoughts and feelings
- tell patients that all questions are good questions
- stress the importance of information-seeking and elicit questions in an open-ended manner: (e.g. ‘What questions do you have?’)
- check that any questions were answered to your patient’s satisfaction
- talk about the role of clinical trials in health care and how treatments for many diseases have improved over time due to clinical research and the participation of patients in clinical trials
- avoid pushing the recommendation of a specific clinical trial, but, if asked, respond appropriately.
Acknowledgement: NHMRC (National Health and Medical Research Council).Return to Top
Want more information?
If you are a Medical professional and interested in conducting clinical trials, please contact us. There is no charge to join our network. We will provide you with the necessary investigator requirements, GCP training, Standard Operating Procedures (SOPs) and all the fundamental essentials to begin clinical studies.