Before any medication or vaccine is prescribed by a doctor, it has to undergo a series of medical trials that may include both healthy volunteers and patients. Trial participants receive medical screenings and assessments as appropriate to the trial. The investigational products studied in these trials are tested in laboratory tests before being given to people.
Information from medical trials help doctors learn more about treatments, conditions or diseases. They may also show who is more likely to benefit and who is likely to have side effects from a study medicine. There is much that scientists can learn even from trials in which the medicine or vaccine being tested fails to show effectiveness.
How are clinical trials devised – can I play a part in this process?
Patients can help ensure that we measure outcomes of importance to them. That’s the goal of patient interviews before and after testing. Trial participants can help us communicate the effects of our medicines to regulatory agencies and payers, so patients can ultimately gain access to our medicines.
Recently, patient opinions helped us design a trial for an investigational medicine for cutaneous lupus. Patients interviewed by a GSK doctor reported a range of daily disease symptoms and treatments. Patients said they would consider the potential effect of the clinical trial on their disease and daily routine before participating in a trial, to avoid provoking a flare of their disease. That information influenced the design of the trial which begins in 2016.
At the end of a recent cirrhosis trial, patient comments in exit interviews revealed the impact of the disease and the positive effects of the study medication, which helped us decide to progress the study medication.
How will my personal data be used? Can I be assured that my privacy will be protected?
Protecting patients’ privacy is of utmost concern to us as a research organization. All patient identifiable information is subject to stringent security standards.
Whether a clinical trial involves a dozen patients or tens of thousands of patients, many health measurements are gathered as are some personal details about patients. All personal information will be treated as confidential, that is, any information that identifies a patient by name will be held and processed under secure conditions. Access to that information will be limited to authorised personnel running the trial and possibly to representatives of regulatory authorities. Trial participants are informed about this as part of deciding to be in the trial, and consent to these persons having access to personal information so they can inspect and audit the trial to ensure its proper conduct.
When people volunteer for clinical trials they expect that the results from those studies will be used to help others, while they also expect that their privacy will be protected. We want no volunteer’s effort to be minimized or privacy violated, so we share trial data through an online system that enables other researchers to request access to anonymised patient level data that sit behind the results of our clinical trials. We believe that sharing these data with other researchers will help advance scientific understanding and improve patient care, while anonymising the data helps protect patient privacy.
This system lets researchers examine the study details more closely, do their own analyses and learn more about medicines and how they can best be used.
How do I find out the results of the trial I participated in?
For years, we have been providing clinical trial results summaries that anyone can access on the internet. GSK leads the field in this area as the first pharmaceutical company to launch a public accessible online clinical trial register back in 2004. We make publicly available the results from all our trials, regardless of whether they are positive or negative.