There are many new drugs for lung cancer that are currently in various clinical trials in China, and perhaps your doctor has communicated with you about them.
But do you really understand what it means to participate in a clinical trial of a new drug? What are your rights and obligations? Here are a few questions to clear up your confusion.
Related reading:
Many patients still have concerns and misconceptions about participating in clinical trials after hearing from their doctors, so here are a few common misconceptions to sort out and clarify.
1. I’m a “guinea pig” and I’m at the mercy of my doctor
Human trials are very different from animal trials in that you have full autonomy in the clinical trial process, the trial prioritizes the rights of the patient, and you can choose to participate, or not participate, in the clinical trial; even if you do participate, you have the right to withdraw at any time if you believe the trial is harming your interests, and your supervising physician will not be biased against you for withdrawing.
If you have real difficulties at a particular follow-up visit during the study, you can talk to the study doctor and make adjustments to the follow-up visit, to the extent allowed by the protocol and without compromising the safety and efficacy of the treatment.
2. New drugs must be more effective than standard therapy
New drugs are not necessarily more effective than standard therapy, and efficacy varies from person to person. Theoretically, new drugs have often undergone preclinical studies (e.g., cellular experiments, animal tests) before being tested in clinical trials, and then in phase I, II, III, and IV clinical trials, with control groups generally designed only for phase II and III clinical trials. In fact, there are three possible outcomes for a new drug compared to a standard treatment: inferior (the new drug is worse than the standard treatment), equivocal (both are equally effective), and superior (the new drug is better than the standard treatment), and current clinical trials tend to be equivocal/effective studies.
3. There is absolutely no need to draw so much blood in clinical trials
Blood draws in clinical trials include three types of situations: routine laboratory blood collection, blood collection for trial-specific requirements, and blood collection for exploratory studies.
1) Routine laboratory blood collection, where the initial blood collection is to confirm your eligibility for enrollment in a clinical trial, i.e., blood for screening tests or baseline blood collection; subsequent blood collection is for your safety and to compare with the results of the baseline blood collection to see what effect the drug has had on your organ function, etc. The safety blood test is determined by the requirements of the test protocol and your specific situation.
2) Trial-specific requested blood collection, depending on the purpose of the trial, is used to obtain data related to the trial drug. With the increasing understanding of targeted therapies and bioimmunotherapy, it has been found that many targets and markers change with treatment, so many clinical trials now require blood collection from markers that coincide with the time of efficacy evaluation, and most of these blood samples are mandatory and will be sent to a central laboratory for uniform testing and analysis.
3) For the exploratory study portion of the clinical trial, some trials are optional and you can choose to participate in the main study only and not the exploratory study portion. Of course, there are some studies that require you to participate in the exploratory study as long as you participate in the main study, so you can consult further and weigh the pros and cons before deciding whether to enroll.
4. Clinical trials require several good CTs (or MRIs, bone scans), which are completely unnecessary
Imaging required in a clinical trial is usually one of three things.
1) Before dosing, an enhanced CT, MRI, or bone scan may be needed, first, to understand your disease stage, which has different treatment options for different stages, and second, to confirm that you are eligible for enrollment in the clinical trial and to understand the overall condition of the tumor before dosing.
2) CT/MRI or bone scans are done every 2-3 cycles during the clinical trial (set according to drug action characteristics and protocol requirements) to assess drug efficacy, detect disease changes in a timely manner, and guide drug use.
3) When certain adverse reactions occur (e.g., interstitial pneumonia or intestinal obstruction) that cannot be confirmed by hematologic testing, further imaging may be required on an ad hoc basis to clarify the patient’s condition and guide the next step of treatment to avoid putting the patient at risk due to adverse reactions.
5. It is difficult to ensure my safety once I enter a clinical trial
The fact is that clinical trials are conducted under close supervision and in accordance with rigorous protocols. There are regulations in place to protect patient safety and rights throughout the process, as well as study physicians, study nurses, ethics committees, and more to protect you.
1) Before starting a new clinical trial, a protocol (plan) needs to be developed based on the results and data from previous trials. The protocol needs to be approved by the Chinese State Drug and Food Administration (CFDA), or the US State Drug and Food Administration (FDA).
2) After receiving CFDA/FDA approval, an investigator meeting needs to be held to discuss the feasibility of the trial protocol and safeguards for subject safety before the trial can be conducted in different hospitals.
3) The finalized trial protocol from the investigator meeting will be submitted to the ethics committee at each hospital for review and approval, and will be approved only if the ethics committee believes that the benefits to the subjects outweigh the risks.
4) During the course of the trial, the study doctor will arrange for you to have regular visits and appropriate tests to learn more about the efficacy and adverse effects, and you will also need to cooperate and follow up as regularly as possible to ensure safety.
5) The contact information for the study doctor is included on your informed consent form. You can contact him/her for any discomfort during the clinical trial and get appropriate instructions.
6) You can also call the “XXX Hospital Ethics Committee” listed on the informed consent form if you believe that the study doctor has acted in a way that is detrimental to your interests during the trial.
6.
6. Problems in the clinical trial and who to call
1) It is your “right to be fully informed” to talk directly to your study doctor if you have questions about any of the items on the informed consent form before you sign it.
2) If you have treatment-related questions during the course of a clinical trial, you can talk to the principal investigator or study doctor in charge of the trial. If they cannot be reached, you can contact the appropriate clinical research nurse or clinical research coordinator (CRC), who will assist in making an appointment with the study physician. In particular, if you encounter an urgent medical problem, be sure to contact one of these individuals, who will make every effort to coordinate a solution to ensure the safety of the subject patient.
3) If follow-up problems are encountered, they can be adjusted or resolved by the appropriate clinical research nurse or clinical research coordinator (CRC), who will refer to the principal investigator or study physician if they cannot resolve them.
4) If you encounter advocacy issues, you can first communicate with the principal investigator, study physician, or study nurse responsible for this trial, and if you do not receive a satisfactory answer, you can contact the hospital ethics committee to communicate a resolution.
Co-reviewed by: Guangdong Provincial People’s Hospital Guangdong Lung Cancer Institute Dr. Tu Haiyan, Associate Chief Physician Dr. Sun Yueli Dr. Peng Lunxi
Co-Author: National Institute for Clinical Drug Trials, Peking University Cancer Hospital Dan Li, Nurse-in-Charge