A clinical trial is a research study conducted to find out whether a treatment medical strategy or device is effective and safe for human use. Such studies help to evaluate the type of medical approaches that work best for specific diseases or groups of people. Clinical trials help to avail the best data for decision making in the healthcare sector.
What is a Clinical Trial?
Clinical trials begin with a long and careful research process conducted in a laboratory where ideas are brought to life by scientists and eventually tested to see whether they work. They may start the testing on animals to see the effect of the approach on a living body should the approach seem promising. However, if an approach works on an animal in the laboratory, this does not certify that it will work well on a human body and at times shows an opposite effect to that seen on the animal. It is because of this that the same test needs to be carried out on a human being to see whether it is fit for human use.
Trials often start with a small group of patients for safety purposes, and the effects of the approach monitored to see whether there is any harm it causes on the patient. A clinical trial may result in the following;
- Show signs of improvement in the patient
- Have no effect at all
- Cause the patient unexpected harm
These outcomes are of great importance because they help to advance medical knowledge and improve patient care.
Who Takes Part in a Clinical Trial?
Various types of people take part in clinical trials. Some may be suffering from a condition or a disease, while others may be healthy. For research done on healthy volunteers, the procedures are usually conducted to develop new knowledge and help define the limits of ‘normal’. They are not usually done to benefit the person taking part. This proves that healthy volunteers play a vital role in research.
On the other hand, a patient volunteer is one that that is suffering from a known condition or disease, and takes part in research for better understanding of their condition, diagnosis or treatment. It is important to note that these procedures may or may not be of benefit to the patient volunteer. Patient volunteers may also take part in similar studies as those with healthy volunteers for comparison purposes and not necessarily for treatment purposes.
Talk to Your Doctor
If you want to get in a clinical trial, you may want to start with talking to your doctor or any other member of your healthcare team. They may be able to recommend a clinic trial that you can benefit from or even help you by doing the research themselves to get a suitable one for you. They will also help you answer any questions you may have with regards to joining one. Some doctors may not know any clinical trials or not make any appropriate recommendations for you. In such instances, you may choose to seek a second opinion about your treatment options and taking part in a clinical trial.
Do Your Research
If you decide to look for a clinical trial on your own, below is a guideline of the steps you can follow to find a clinical trial suitable for you. Please do not use this information in place of advice from your doctor.
- Collect information about your condition – It is important to know specific details about your condition if you decide to look for a clinical trial. This is because you will need this details for comparison with the eligibility criteria for a trial that may be of interest to you. The eligibility criteria is simply a guideline to show who is able to participate in a specific clinical trial. You can ask your doctor to fill out the form should you need help.
- Finding a clinical trial – There are very many clinical trials taking place in the United States. Some trials are sponsored by researchers in hospitals and academic centers, while others are funded by for-profit groups such as drug companies. Some of the trials are also funded by non-profit organizations. There is no single list containing every clinical trial and this is because of the many types of sponsors as you can see in the examples above. There are a number of online sites that you can visit and these include;
- Drug and biotechnology company websites – Many companies provide lists of the clinical trials which they sponsor on their website. You can also find a list of member companies included in the Pharmaceutical Research and Manufacturers of America (PhRMA) website, many of which sponsor clinical trials.
- gov - This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. It lists 259,039 studies with locations in all 50 states and 201 countries, recording more than 199 million page views every month as of February, 2017.
- Clinical trial listing services – Lists of clinical trials are provided by some organizations as part of their business. Such organizations do not take part or sponsor clinical trials, but receive fees for helping to find patients for trials. They are usually paid by drug and biotechnology companies.
- Carefully analyze the trials that you have picked interest in – Now that you have collected information about your condition to help establish whether your eligible and found a few trials that interest you, you need to carefully analyze the protocol summary for each trial. The questions listed below will help you to narrow down your list so that you remain with only those trials that you will be contacting for more information.
- Eligibility criteria – Do the details of your condition match the trial’s eligibility criteria? Other trials may look for a patient that has already received treatment while others may look for one that has received no treatment at all. This will help you see whether you are eligible for that trial.
- Objective of the trial – What is the trial’s goal? Is it to cure your condition or to manage it? Do they want to lessen the severity of the symptoms you are experiencing? Find out whether you have matching objectives.
- Location of the trial – Some trials may take place in more than one location, are you okay with this? How far will you be willing to travel? You will also need to know whether your travel costs will be caters for by the sponsoring organization, and if so will it be partially or fully.
- Duration of the trial – How long will the trial run? Will you able to spare the time required? Will it be ideal for you and your family? Not all protocol summaries tell you how long the trial will run, you can however ask for this information once you contact them.
How to Apply
After you go through these questions and still find that there is a clinical trial suitable for your needs, you will now have to contact the team running the trial.
- Get in touch with the team running the trial – Here are a few ways that you can contact the clinical trial team;
- You can contact the team directly. The phone number of a person you can reach out to for more information is usually included in the protocol summary. When you call this number, you should ask to speak to the trial coordinator. The trial coordinator can answer questions from both the patients and their doctors and it is also their job to determine whether you are likely to be eligible to join the trial. Nevertheless, a final decision will probably be made after you have met the doctor who is part of the trial team.
- You can ask your doctor to help you contact the clinical trial team for you. There are some questions the trial coordinator may ask about your diagnosis or overall health that you may not be able to answer. Your doctor will be in a better position to help you answer such questions.
- The trial team may contact you directly using the email address or the phone number that you used when registering to use the clinical trial listing service website.
Whether you contact the clinical trial team directly or ask your doctor to help you do it, it is important to try and get answers to all the questions that you may have. This will help you decide whether to rule out this particular trial or give it a go. Here are some questions you might consider asking.
Should you have any more questions or concerns, you can direct them to your doctor and discuss them to help you reach a final decision. Your doctor can also help you shed some light on the potential risks and benefits of all the treatment options available for your condition including the clinical trial. This will help you compare standard treatment for your condition to treatment in a clinical trial. You may reach a decision to proceed with seeking clinical trial treatment or not. This will be entirely your choice.
- Make an appointment – If you decide to join a specific clinical trial, for which you are eligible, you should schedule an appointment and visit the team running the trial. They will then vet your eligibility and if fit, you can start the clinical trial.
It is important to get all questions regarding cost answered even before you decide to take part in the trial. In most cases the study sponsors will cover all costs associated with special tests, procedures or extra visits to the doctor. It is however not right to assume that they will be covered by the sponsor and to find out how they will be covered so that nothing comes as a surprise later on.