Image-Point-Fr/ShutterstockWhen Beverley Sewell, 54, was diagnosed with an aggressive form of breast cancer in April 2014, she was determined to get rid of it for good. Even though her tumor had been caught early, Beverly, 54, a British call center adviser from Cornwall, opted for a mastectomy, chemotherapy and radiotherapy—and agreed to join a clinical trial.
Her oncologist explained the trial carefully. Participants were selected at random to receive one of two treatments being compared in the trial. Beverley received the standard amount of six chemotherapy treatments but the last three included infusions with a new combination of the drugs Herceptin and Pertuzumab that previous trials had suggested would target Beverley’s tumor cells more effectively. The drugs were safe; she wouldn’t be a guinea pig. There would be regular check-ups and tests, and if she had any side effects or concerns, she could call the hospital 24/7. Doctors would continue to monitor her for ten years.
“I felt honored to be asked,” says Beverley, now cancer-free and feeling great. “First of all, I knew they were going to take great care of me. But most important of all I felt I could be part of something that could cure cancer and help stop other people suffering in the future.”
Beverley Sewell joined one of the estimated 10,000 clinical trials currently taking place in Europe. About a quarter are multinational studies, which, because they benefit from a larger pool of participants, can enable the trials to be completed more quickly and result in promising treatments being licensed for use more swiftly. All are aimed at finding new and improved ways of treating, diagnosing and preventing disease.
Explains Dr. Fergus Sweeney, “It’s important we understand how medicines work: Do they have the beneficial effects we’re trying to achieve, and what risks come with that.” Sweeney is head of inspections and human medicines pharmacovigilance at the European Medicines Agency (EMA), which is in charge of the evaluation and supervision of medicines in the EU. “‘This can only be demonstrated in an objective way by running well designed clinical trials.”
Here’s what you need to know before joining one:
ZynatiszJay/ShutterstockHow do I find a clinical trial?
If you have a particular condition, your doctor may suggest a suitable trial. Contacting a patients’ association or searching an online database are other avenues to explore. The EU Clinical Trials Register (clinicaltrialsregister.eu) contains details of all trials authorized to take place in the European Economic Area (EEA), while clinicaltrials.gov, run by the U.S. National Institutes of Health, lists trials in the US and 190 other countries.
You will only be accepted if you meet a trial’s strict eligibility criteria. Always talk to the doctor in charge of your treatment before you take part.
How do I know it’s safe?
“In Europe, before a clinical trial can commence, it needs two authorizations, one by the ethics committee—an independent body consisting of medical doctors, lawyers and experts in pharmacology—and one by a competent national authority,” explains Dr. Thomas Sudhop, head of scientific services at the German competent authority, the Federal Institute for Drugs and Medical Devices.
Trials are carefully designed, based on previous research in the lab, on animals and other patients. They are also closely monitored. Says Sweeney, “The system is robust and increasingly reinforced to bring risks to a minimum.” But it’s still a new treatment, so, as Sudhop points out, “it’s not completely risk-free.”
That became clear during a trial at Northwick Park Hospital, London, in 2006, when six young men almost died after receiving a drug being tested on humans for the first time. Since then the guidelines on first-in-human-trials have been tightened. Such severe safety incidents in phase 1 trials are extremely rare.
What will I be told?
You should receive detailed written information. “You should be given time for you and your family to read this carefully, and have the chance to ask questions,” says Dr. John McMurray, professor of medical cardiology at the University of Glasgow. He led the international trial of a new treatment for heart failure that was stopped early because of “overwhelming benefit”—cardiovascular deaths were cut by a fifth. “Only if you are comfortable with this information should you sign the consent form.”
You need to be clear on what treatments are being tested and how. Will there be many hospital visits, tests, onerous questionnaires? How far you will have to travel, and will it fit in with work or other commitments? What are the potential benefits and side effects? Has the treatment been used safely in any other trials? You have every right to leave a trial, but, as Sweeney cautions, “You shouldn’t stop tablets overnight—consult with your doctor first.”
Ultimately, you need to trust the doctor conducting the study. “You should have a good feeling,” emphasizes Sudhop.
What are the benefits?
“For the patient a clinical trial is a chance to get a medicinal product which is currently not available,” says Sudhop. However, as trials often compare the therapy with the best available or standard treatment and randomly select which patients receive which treatment, you may not get the new treatment. Even if you do, it may not make you better. Or if it does help, you may not be able to continue with it after the trial ends.
But one thing is certain: you will receive extra care and attention. “Studies indicate that a patient in a clinical trial tends to do better compared to an equal patient outside a clinical trial,” says Sweeney.
You will be making a valuable contribution to research. “Hopefully, you will help future patients with the same medical problem as the one you have,“ says McMurray.
“If we want new medicines for ourselves, our family or our children, then it’s necessary to carry out clinical trials,” Sweeney points out. “We have to be open and willing to participate.”
Beverley Sewell agrees. “Go for it,” she urges. “Don’t be afraid of it. You will be monitored very carefully. I have every confidence in the trial drugs and feel very positive for the future.”