Today is a golden age in clinical trials for migraine treatments. CGRP, genetics, devices, behavioral interventions and many more approaches are being clinically trialled to collect scientific evidence to support innovative new and effective treatments.
In a few minutes searching several free directories listed below, you can quickly discover actively open (recruiting) migraine clinical trials looking for participants. Here are a few examples of how many studies are recruiting in these 3 cities:
- New York - 28 recruiting studies
- LA - 10 recruiting studies
- London- 4 recruiting studies
This patient guide for clinical trials is for those who are interested in participating in a trial but do not know how to get started and what to look out for.
Clinical trials can be a mutually beneficial activity that provides an opportunity for the patient to receive compensation, experience expert care, receive free treatment and help contribute to medical innovation.
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1. Why participate?
Clinical trials are research studies to evaluate if a specific treatment is safe and effective.
Carefully designed clinical trials are the fastest and safest way to find new and more effective treatments. (1)
There are a number of potential benefits for patients who participate in clinical trials, these include:
- getting access to new research treatments before they are widely available
- taking a more active role in your own health care
- helping contribute to medical research
- earning extra money
- improving your own health
Top Reasons To Participate In Clinical Trials
How much money can you earn from clinical trials?
It is very unlikely that your able to make a living from participating in clinical trials. Typically, the payment is intended designed to compensate you for your time and expenses incurred whilst participating in the trial so that you are not financially out of pocket for participating.
The compensation will also depend on many other variables including the nature of the study and the number of physical visits required. Compensation can range from $50 to over $1,000 for trials which require many frequent visits (ie. +50 visits) and followups. Some trials may not have any compensation component.
2. Who can participate?
Every clinical trial has guidelines about who can participate. This is referred to as eligibility criteria.
Inclusion criteria are what qualify someone for a particular trial. Exclusion criteria are those which disqualify or rule out an individual for a trial.
For example: a migraine trial may be looking to recruit female participants above the age of 18 (inclusion criteria) who are not pregnant (exclusion criteria).
Whilst it can be disappointing to miss out on a study, the practice of adhering to this inclusion or exclusion criteria is an important principle in producing reliable and scientifically valid results.
3. Risks and benefits
As mentioned above, clinical trials help evaluate the safety and efficacy (effectiveness) of a specific treatment. However, trials occur before the safety has been fully tested, so should we be concerned about our own safety going into the clinical trial?
There are safeguards in place but this is something you should still consider.
Clinical trials are governed by the same ethical and legal codes that govern medical practice. In most countries, clinical research is federally regulated with protective measures in place for the benefit of participants.
Studies are required to follow a carefully controlled protocol (a study plan) which outlines in advance what the researchers will do during the study. As the clinical trial progresses, researchers also record the progress of the trial.
There are still risks to clinical trials, these include:
- Unpleasant, serious or even life- threatening side effects to treatment
- Ineffective treatment results for the participant
- The trial may require more trips to the study site, more treatments, hospital visits or more complex requirements than otherwise expected
It's important to note that the phase of the clinical trial may also affects the risk involved in participation. See the below section on 'How Clinical Trials Work' for more explanation.
These are side effects or any undesirable result or effects from the treatment. Adverse events from clinical trials can include both short and long term side effects.
When clinical trials are well designed and executed they are a good opportunity for participants to:
- Play an active role in your own healthcare
- Get access to new and innovative treatments before they are available to the public
- Help advance medical research and support others with your condition
- To potentially improve your condition
As a participant you generally have the right to:
- Withdraw from the study at any time
- Ask questions at any time concerning the trial or the treatment
- Seek compensation for complication or injury resulting from the trial
- Be informed of any significant new findings that may affect your willingness to continue participation
- Be provided 'Informed Consent' agreement; see below.
Everyone who participates in clinical research should understand the key facts of the clinical trial before deciding whether or not to participate.
The research staff will explain the details as well as provide written information including the purpose, duration, required procedures and key contacts of the trial.
Once the participant understands the details of the study including the potential risks and benefits then an informed consent document is provided for signing.
This document is not a contract, it is called an informed consent agreement. The participant can still withdraw from the trial at any time.
4. How clinical trials work (Protocols, Placebos & Controls)
Protocol is the plan which the clinical trial follows. These plans are carefully designed to protect the safety of participants as well as to test the treatment efficacy.
A protocol is responsible for:
- who participates in the research
- the schedule of tests
- duration of the study
A placebo is an inactive pill or other false treatment that has no therapeutic value. Many clinical trials require a placebo to evaluate the effectiveness of a treatment in a scientifically robust manner.
A control or control group is a standard that it used as a comparison to the treatment group. For example, one group of participants may be given the experimental drug whilst the control group is given either a standard treatment or a placebo.
What is "double blind placebo"?
Double blind refers to a trial design where two parties are prevented from knowing what they have. In most cases the parties are:
- The participant: who is "blind" to whether their treatment is real or a placebo
- The investigator: who is "blind" to what each individual is receiving to avoid any potential bias.
In this way the study is a double blind.
When placebo is mentioned it refers to the control group (see above for a description). In this case the control group is using a placebo. Often trials may compare a new treatment to another, in these cases the control group will use a comparison treatment instead or in addition (as a third group) to a placebo control.
A clinical trial where both the researchers and participants know which treatment is being administered is called an open label trial.
Phases of clinical trials
This infographic is a useful summary of the clinical research cost, timeframe and effort.
It all begins in the basic research and discovery phase and moves to pre-clinical before clinical trial begin.
The clinical trials themselves occur in phases. Each phase has it's own purpose and answers different questions:
Phase I trials: researchers test is new treatment in a small group of people (around 20-80) for the first time to evaluate the safety, safe dosage range and identify side effects. Generally, Phase I trials will have a higher level of risk for the participant as there has been less opportunity for human studies to measure the full safety and side effects by this point.
Phase II trials: the treatment is given to a larger group of people (around 100-500) to evaluate its effectiveness and to evaluate its safety further.
Phase III trials: in this phase the treatment is given to an even larger group of people (around 1,000-5,000) to confirm efficacy data, monitor side effects and collect information that will allow the treatment to be used safely.
Phase IV trials: these may occur after the product becomes available to the public and are used often for marketing purposes to further optimise the treatment use, benefits and minimise side effects.
Phase III trials are where most participants are likely to participate simply due to the sheer numbers required. Fortunately, it is generally also one of the safest Phases as previous trials have successfully passed safety standards and protocols required by regulatory bodies.
If you are concerned about the risks involved in the study, then the research staff are required to answer your questions and provide you with as much information as reasonably possible and relevant.
You can also get a second opinion from your own healthcare professional so you are comfortable with any decision you make.
5. How to find migraine clinical trials
It is getting easier all the time to participate in clinical trials.
The good news is that there are more clinical trials and migraine research happening in the past few years than ever before.
The main ways to find out about clinical trials are:
- Online - directories
- Health professionals - like your doctor
- Research centers, universities, migraine foundations or charities or large headache centers.
How Do People Find Out About Clinical Trials
This is perhaps the most well known directory in the USA, however it is also a big global directory. Whilst it is a service based in the US, it includes many research studies outside of the USA. See the fine print in the top right hand corner.
When you enter "migraine" into the search column, if you are looking for a studies to participate in, make sure you check the 2 boxes:
- include only open studies (i.e. studies open for application)
- exclude studies with unknown status (i.e. remove anything where you have to call to find out what's going on)...
- IMPORTANT: to search your location, enter the following including the inverted commas: "migraine" AND " New York" or "migraine" and "London" for example. That way you'll see results
- See below:
International Clinical Trials Registry Platform
This is a World Health Organisation directory which groups together several clinical trial portals into one location.
There are trials vast array of locations such as the US, China, EU, Netherlands, Brazil, Germany, Japan and over a dozen other locations.
With this portal some filtering is required to find actively recruiting trials in your country.
To search for actively recruiting clinical trials, click "Advanced Search" which is located just above the search bar.
Then set your status to "recruiting", select your search term "migraine" and your country and then hit "Search" to receive actively recruiting migraine trials in your country.
The advantage of this search is that you can find trials in countries as varied as Zimbabwe and Poland but you can't narrow down specifically by city it seems.
Of all of the international clinical trial directories, TrialReach is the easiest to use. It's also based on your location which is helpful.
It does ask for a little more information like your age, gender and location. But these are used to filter out irrelevant options. It only asks for an email address if you want to save your search or receive notifications about new trials which meet your search criteria.
National clinical trial resources & directories:
USA- Center Watch offer a free clinical trial listing service.
UK - The Migraine Trust visit their research page for updates on opportunities to participate in migraine trials.
Australia - Headache Australia visit their research page for updates on opportunities to participate in migraine trials.
Australia and New Zealand - Australian New Zealand Clinical Trials Registry - this is an online register of clinical trials being undertaken in Australia and New Zealand.
6. Questions to ask research staff
It's important to have a good understanding about the study before you decide whether to participate or not.
By addressing these questions you'll be in a much better position to make an informed decision and be able to sign the Informed Consent Agreement that is often required before you proceed.
- What is the eligibility criteria?
- What is the main goal of the study?
- Does the study involve a placebo?
- Does the study involve an existing treatment already available to the public?
- How is the treatment delivered?
- What is the duration of the study?
- Are there any migraine frequency or duration requirements?
- What is already known about the study treatment? Have study results been published?
- Do I have to pay for any part of the study? Will insurance cover any of these costs?
- What reimbursement will I receive for costs or childcare?
- Will I still be able to see my own doctor?
- Will I still be able to take my usual treatments?
- If the treatment works for me can I continue using it after the study?
- How is my private information used? Who else will know I'm participating in a clinical trial?
- Will I receive follow-up care after the study has ended?
- What will happen to my medical care if I stop participating?
- Does the physician or investigator have any financial or special interest in the clinical study?
- What are the credentials and research experience of the physician and study staff?
- Who regulatory and/or institutional review boards have approved the safety and design of the clinical trial?
Taking part in clinical research is a service to the broader community. It's also something that can benefit you personally with financial compensation, new treatment and medical care.
But before proceeding make sure you understand whether you're eligible and exactly what the risks and benefits are. Ask questions and make sure you understand the answers so you can make an informed decision.
Let me know in the comments if you're considering participating or are currently involved or have been involved in any research trials in the past. How was your experience?
1) The Center For Information & Study On Clinical Research. Participation https://www.ciscrp.org/education-center/important-information/ Accessed 31 Aug 2016.
2) The Center For Information & Study On Clinical Research. CISCRP, 2013; N= 5,701 People Worldwide