Let’s talk clinical trials – a TASK Academy series – article #4 –
Having various search engines at our fingertips and information constantly being fed to us, whether asked for or not, is part of the technological world we live in. So how do you determine whether the information you receive is fact or fake?
During the past year a lot of misinformation on COVID-19 has been doing the rounds, and even more so now with the approval and distribution of the various vaccines.
The first phase of vaccine rollout to healthcare workers is a secret experiment to see how safe the vaccine is.
Vaccines that are approved for use in South Africa have already undergone rigorous clinical trials to evaluate them for safety and efficacy.
I believe that the public still has a lot of reservations and questions surrounding the topic of clinical trials as there are many misconceptions and myths floating around as truths. In today’s article I want to address some of them.
FAKE vs FACT:
- FAKE: Clinical trials are dangerous as they use medicine that has never been tested before
FACT: All clinical trials are born from a pre-clinical trial stage. This stage is what we call the “discovery and exploratory research stage” where libraries, built over decades with thousands of possible compounds to treat a disease, are stored. They are scanned through to find a possible match to treat the disease. Only the promising compounds are then tested in laboratories and sometimes also in animals. This pre-clinical stage can take years and only after all the collective experience is reviewed by highly qualified experts the use of a product in clinical trials in humans is permitted. All safety and efficacy data are documented in a book that we call the “investigational brochure”, and the first phase of an in-human trial (Phase 1 of 3) will only start if the compound information in this book shows that there is no or very low risk for human use
2. FAKE: Clinical trials have more risks to me than benefits
FACT: As clinical trials are designed for research purposes, some level of risk is involved. However, a participant will only receive the investigational product (IP) after it has gone through rigorous testing processes that showed it to be safe for human use. Participant safety and wellbeing is a key principle in clinical research and is documented in the international Good Clinical Practice (GCP) guidelines. If you choose to participate in a clinical trial, you will be informed upfront during the informed consent process about any possible risks that may exist, and you will be given the opportunity to ask questions and you can always choose not to participate or withdraw your consent. You only need to sign the consent and participate if your concerns were addressed, and you agree to take part
3. FAKE: Once I decide to participate in a clinical trial, I must finish the trial and cannot continue with any treatment at my clinic or private doctor.
FACT: Participating in a clinical trial is voluntary. Signing a consent form is not like signing a contract. There is no “notice period”. You do not even have to give a reason for withdrawing consent if you do not wish to. You can withdraw your consent at any stage in the trial, even directly after you signed consent. When you start the trial, you might be asked to stop your current treatment as you will now receive the investigational product (or IP in short). When you withdraw consent, you will be taken off the IP and you will be referred to your local clinic or private doctor. If you agree to it, we can also inform your doctor / clinic that you are on a trial so that they can also be aware.
4. FAKE: I have heard from a friend that she “failed” the screening test to be on a trial.
FACT: First and foremost – there is no “health check” that you can fail. The protocol for a clinical trial includes what we call “eligibility criteria” that we check during the first visit after you consented (i.e., screening visit) that suggests who can (inclusion) and who cannot (exclusion) take part in the trial. These criteria are collected from previous trials that identify the people most likely to benefit from the trial medication. For instance, if the trial investigates know how well a new blood pressure medication helps for hypertension, participants must have hypertension to participate. If the screening procedure shows that they do not have hypertension, or not severe enough hypertension, they cannot participate. The screening process also ensure you are not taking potential prohibited co-medicines or have any current medical condition that will put you at risk when taking the investigational product. It is important to understand that the eligibility criteria are not used to reject you personally but are rather there to protect you and ensure that it’s safe for you to take part in the trial.
5. FAKE: If I join a clinical trial I can be treated with a “sugar pill” and thus get no treatment at all.
FACT: The decision about whether to use a sugar pill / placebo in a clinical trial is based on how serious the illness is, whether an existing treatment is available and other considerations that ensure a high ethical standard. If you have a serious or life – threatening disease, the best available treatment (called “standard of care” – SOC) will be used in the trial, instead of a placebo, together with the IP. Usually you will be “randomised” (randomly selected – for instance with a 50/50 chance) to either be treated with the SOC / placebo or IP.
6. FAKE: My husband and I were not allowed to know what treatment he was given when he was participating in a trial. That is not fair.
FACT: ”Blinding” helps to obtain accurate trial results. Participants and treating staff often hope that the product tested will be successful. Such influence on assessments can be excluded if it is not known if the product given is a placebo or real A “single-blind” study is when the participant does not know, “double-blind” or even “triple-blind” is when the participant and the researcher (double) and the participant, researcher, and statisticians (triple) do not know what treatment the participant is receiving. These are yet stronger methods to prevent any bias in data collection and interpretation of results. When the trial is finished, and all data is collected and locked, all parties may be “unblinded”. If at any stage it is medically important that the treatment be known the blind can be “broken” during a study.
7. FAKE: My personal information will be published, and everyone will know my health status and that I am taking part in a trial.
FACT: Confidentiality is key in clinical trials. The only document that can link you to a trial is the informed consent form. There are only three copies of this form. One is with you, one is in your folder at the study site, and the third form is stored in a secure investigator file at the research site. We use lockable cupboards with restricted access to only staff approved to work on the trial, the ethics committee and regulatory authorities’ inspectors and study auditors on a trial. Therefore, not even the sponsor / funders of a trial will be made aware of your personal information. All information captured in the study is de-identified by using a number / coding system and we black out your name on any documents that we receive. Only the de-identified codes will be used on reports, samples, and publications.
8. FAKE: If I participate in a trial and need medical treatment as a result of the trial, my medical aid will have to pay for this, and it will drain my benefits, or I will have to pay for this from my own pocket.
FACT: In South Africa, all clinical trials must have clinical trial insurance. They call this a “no-fault-compensation” insurance which means that if you need medical treatment resulting directly from clinical trial participation, any reasonable medical costs can be claimed from the clinical trial insurance without having to prove that this was indeed caused by the trial. To be fair, it must be mentioned that this only applies if you followed the instructions given to you. This will be included in the consent form that you will sign, and you may request to see all the conditions (ABPI guidelines).
9. FAKE: My doctor or clinic must refer me to take part in a clinical trial
FACT: Your doctor or clinic might not always be aware of the various trials approved and open to recruitment for your particular disease. You therefore do not need to be referred by your doctor or clinic. In South Africa, every trial must be registered on the South African National Clinical Trial Registry (SANCTR) managed by the department of health: www.sanctr.samrc.ac.za. This registry provides the public with updated information on clinical trials on human participants being conducted in South Africa. It will provide you with information on a trial’s purpose, who can participate, where the trial is located, and contact details. The National Institute of Health (NIH) also has an online database that you can search for appropriate trials: www.clinicaltrials.gov. There is also the Pan-African Clinical Trials registry (PACTR): https://pactr.samrc.ac.za – a valuable tool for exploring the current status of research in Africa in different areas of medicine and in different countries.
10. FAKE: Only doctors can work on a clinical trial
FACT: There are a huge variety of job roles available in clinical trials. From laboratory-based research and development, clinical trial conduct at the research site that requires nurses, pharmacy staff and administrative staff, regulatory affairs, manufacturing, engineering, quality assurance, quality control, validation all the way through to marketing, sales and distribution. Almost any skill set will find a career to match. To work in clinical trial, you will need a certificate in Good Clinical Practice (GCP). Visit our website www.task.org.za and register for our one-day accredited GCP and also GCLP (good clinical lab practice) courses.
Clinical trials conduct research to discover a new or better cure. This does naturally involve experimental elements. A small risk is always there even after everything is done to make this safe. We are extremely grateful to our participants who venture onto such a journey with us. Without our participants, progress in medicine would not be possible and we would still be using olive oil to treat HIV and inhale garlic to make TB go away.
It is always good to ask questions and never assume, but do not lend your ears to public myths and misconceptions – ask the experts at TASK (www.task.org.za) to be able to make an informed decision.
Till next time,
Head Quality Assurance and Regulatory, Founder TASK Academy
With years of hands-on experience and under the leadership of Karen Cloete, TASK Quality and Regulatory team ensures high-quality standard and GCP compliance of all trials conducted at TASK. They also offer consulting services to sponsors and sites – feasibility assessments, site start up support, regulatory submission support and clinical trial auditing (GCP / GCLP and vendor audits). Through the academy clinical trial training and capacity development services are also provided.