The Importance of Informed Consent in Cancer Research

Fostering novel discoveries in cancer research is a massive undertaking—one that requires extensive coordination among various health and research professionals in their respective fields.

Bringing together experts from a diverse set of scientific backgrounds and creating conditions under which they can easily share and contextualize high-quality data is the key to unlocking the next generation of cancer therapies. This enormous endeavor isn’t merely about scientific progress, however. At its core, it is about helping individual lives to live longer and healthier. Unfortunately, all too often, the research community overlooks and undervalues the key stakeholder of these efforts: The Patients; those who are central to driving cancer research forward.

Without patient data, cancer research would grind to a halt. In fact, there is no more important contribution to the field than that of the individuals who have cancer or are at high risk who offer their data in the name of discovery. The research community is coming to understand that collecting patient data through informed consent is a universal win. For scientists, making patients active rather than passive collaborators provides more robust and reliable data, enabling everything from the creation of advanced comparator cohorts to precision clinical trial design. For patients, getting to see their data put to work gives them the sense of ownership in their own healthcare, as well as helping others battling the illness now and future generations to come.

M2GEN Is Unlocking the Power of Informed Consent

M2GEN is the operational engine of the expansive Total Cancer Care® (TCC) longitudinal observational research study in collaboration with the Oncology Information Exchange Network® (ORIEN)—an alliance among the nation’s top cancer centers. Together with our partners, we are proud to utilize the TCC protocol, which puts patient participation at the forefront of our efforts in the battle against cancer. The TCC protocol leverages the power of informed consent when collecting data from cancer patients, which confers many advantages when compared with data collection methods employed by most observational studies.

How Informed Consent Works Through TCC

When an eligible patient at an ORIEN member institution is identified, the patient is approached by an informed consent specialist who provides information about the TCC research project and the value of patient data in advancing cancer research. If the patient consents, he or she is added to the TCC Active Directory. The data collected can include clinical medical records, test results, and samples of tissue, blood, and urine. With the ability to opt out at any time, the patient also consents to release subsequent medical data and to be re-contacted should additional information or participation in a research project may be of interest or potentially beneficial to the patient.

The TCC protocol is implemented with an Institutional Review Board (IRB) approval, ensuring that all procedures adhere to the highest ethical standards and that patients can feel completely comfortable volunteering their data. Effective cancer research is a data-intensive process, and modern therapies are becoming more individualized and targeted to specific genomic factors, such as the presence of certain biomarkers. As such, the number of participants in a study is highly correlated with developing new insights.

The Benefits of Using an Informed Consent Data Collection Protocol

To date, more than 300,000 individuals have agreed to take part in the TCC research project. That number continues to increase, making the TCC Active Directory among the largest of its kind. The ORIEN success in enrolling patients is, in part, thanks to the informed consent approach, which transforms patients into stakeholders in improving research outcomes driven by their medical information. Because this process allows for the collection of information over a patient’s lifetime cancer treatment journey, M2GEN is able to create an incredibly robust, ever-expanding longitudinal data pipeline. This includes everything from comprehensive clinical data, such as patient demographics and medical histories to genomic information, such as whole exome (DNA) and gene expression (RNA) sequencing data.

The quantity of information collected via the TCC protocol is a testimonial to the efficacy of our informed consent data collection model. However, this is only the beginning of its benefits. Although each patient’s information is de-identified in the TCC Active Directory, clear procedures are in place to ethically identify and re-contact participants by trained qualified research professionals. It’s impossible to overstate the value this provides to researchers. The TCC data is real-world data (RWD), and the ability to recontact patients for further information and participation is invaluable in developing real-world evidence (RWE). Scientists no longer need to rely on disembodied data collected in controlled settings like clinical trials, which may or may not represents the general population. Imagine the power of working with huge quantities of data representing individuals who can be called upon to participate in highly targeted studies or clinical trials.

Collaboration is at the heart of effective cancer research. Together with the ORIEN alliance, as well as our many other research partners, M2GEN is proud to show that patient data collected through informed consent is the best way to move cancer research forward.