The top reasons why patients enroll in Phase 1 clinical trials are “fighting my cancer as much as possible” and “accessing the best treatment,” according to a study presented at the Targeted Anticancer Therapies Congress 2018 (TAT 2018) earlier this month in Paris.
The study underscores the rising interest in patients to take part in early-stage clinical trials due to the introduction of alternative treatments, such as targeted medicines and immunotherapies, and improvements in patient selection.
A team of researchers conducted a study to understand what motivates patients to participate in early research studies, primarily Phase 1 trials.
The study, “Self-questionnaire to assess patient’s preferences for participation in phase I clinical trials,” was presented at the European Society for Medical Oncology’s (ESMO) TAT 2018 conference.
Patients treated at the Institut Gustave Roussy in France were asked to complete a survey assessing their preferences for taking part in Phase 1 or Phase 2/3 trials.
Phase 1 patients completed the survey just before their first clinical appointment for trial discussion and inclusion. Phase 2/3 patients had already been recently included in the trial.
The most frequent reasons that patients from both groups gave for participating in clinical trials were:
- Fighting my cancer as much as possible
- Accessing the best treatment
- Getting the best possible care from expert doctors
The frequency of these answers were 78.4%, 64.7% and 47.1% in the Phase 1 group, and 79%, 61%, and 64% in the Phase 2/3 trial patients.
“In our study, only one in six patients said that clinical trial participation was their only option. More than two-thirds said their reason for taking part was ‘having access to the best cancer treatment,’ Benjamin Verret, MD, of the Drug Development Unit (DITEP), Institut Gustave Roussy and first-author of the study, said in a press release.
These findings suggest an improvement in the public’s opinion of clinical trials. Interestingly, a survey we conducted among oncologists referring patients to our phase 1 trial unit also indicates more public support for early stage trials,” Benjamin Verret, MD, of the Drug Development Department, Institut Gustave Roussy, and first author of the study, said in a press release.
The data is believed to reflect the increasing willingness of patients to take part in early-stage clinical studies.
“The centre where I work, for example has had an increase in referrals to these trials over the last ten years. Cancer therapy is becoming more personalized, and patients may have longer responses and less toxicity than with chemotherapy,” said Markus Joerger, MD, attending medical oncologist who is responsible for the Phase 1 unit at St Gallen Cancer Centre, Switzerland, and a member of the ESMO press and media committee.
Key objectives of Phase 1 trials are to evaluate the safety and dosing of an investigative therapy. An appropriate selection of patients for the trial is crucial to reduce toxicity and increase benefit to a larger number of participants.
Another research study presented at TAT 2018 reported a new scoring method to predict overall survival of patients in Phase 1 immuno-oncology trials that can be used to improve selection of participants.
“The score can improve understanding about the impact of immunotherapy generally,” Joerger said. “In future what we really need is predictive markers for specific immunotherapy drugs. Over the next five years we will have many more immunotherapy drugs and specific predictors should be developed for each therapy.”
Patients’ interest in participating in early clinical trials is no longer because that’s the only way of getting treated for advanced cancer stages. They are more aware of the need for new cancer therapies and the need to gain access to these alternative treatments. And clinical research has improved the selection of patients for early-stage trials, which has led to better clinical outcomes.
“Ten years ago, Phase 1 clinical trials were maybe the only option for patients with a cancer at an advanced stage that would not respond to standard treatment. Today this is no longer the case,” Verret said.
Joerger said that the public knows that treating cancer isn’t just about chemotherapy, which often has side effects.
“We now also have targeted drugs and immunotherapy. In addition, we have a deeper understanding of tumor biology and can better select patients for trials, leading to higher response rates and increased clinical benefit,” he said. “Early stage trials include more patients than before, so there is the potential for greater numbers of patients to benefit.”