CLINICAL DEVELOPMENT IN ONCOLOGY F
rom the sponsor that designs the protocol and the regulatory body which approves it, to the patients recruited
for experimental treatment and the trialists who evaluate them, a clinical trial is a vehicle with many moving parts that achieves optimal speed when each party plays its part. Patients and advocates play no small role in driving treatments to the market, with those voices lobbying for the US Food and Drug Administration (FDA) approval of Amylyx’s amyotrophic lateral sclerosis (ALS) treatment Relyvrio, citing the high unmet need of treatment options for patients despite the treatment’s modest efficacy data, safety risks, and negative FDA AdCom opinion. On Clinical Trials Day, Clinical Trials Arena
sat down with patient advocate and Global Head – Growth & Insights at Savvy Cooperative Kelly Franchetti to discuss how patient advocacy has evolved to drive patient centric clinical trials and where the relationship between patients, advocates, industry, and agency needs to be to advance drug development.
Justine Ra: How has the role of patient advocates evolved in clinical trials throughout the years?
Kelly Franchetti: Patient advocacy has played a more active role in clinical trials compared to 20 years ago, and many factors contribute to this evolution. Patients, as consumers, are becoming much more savvy, and advocacy recognises and is reinforcing that trend. It also helps that pharma and regulatory bodies are actively acknowledging the importance of bringing advocacy early and often into the conversation when it comes to clinical studies.
JR: Does a lack of patient centricity correlate to higher rates of trial termination and patient dropout rates?
KR: Absolutely. I think there’s a direct correlation with not only trial termination and dropout rates, but also with the number of trials that enter “rescue” situations. With patient advocacy at the periphery, trials can lose sight of patient recruitment and retention,
Kelly Franchetti, Global Head – Growth & Insights at Savvy Cooperative
and as a result, find themselves having to address these patient centric aspects of a trial much further down the line. The emphasis on the patient has improved over the years, getting patients and advocacy involved as early as possible in the life cycle of a trial. And it is important to distinguish patients from patient advocacy, both of which need seats at the table, because patient advocacy represents the greater voice of patients as a collective while a patient represents the individual. A clinical trial is an ecosystem that is optimal when advocacy and patients are the first line to discuss how a trial will be operationalised and what measures will be used for evaluation.
JR: What are the shared goals of patient advocates, pharma, regulatory bodies, and the patients themselves? Where is the biggest disconnect between these groups?
KR: The commonality that holds all these groups together is the dedication towards stopping or changing the trajectory of a disease and bettering patient lives. Where the disconnect comes in is that each of these groups have different primary goals. Pharma’s primary goal is very different from the patient’s primary goal, which is different from agency’s primary goal, especially when it comes to the design of a clinical study. Endpoints, in particular, can be a source of commonality but also be the driver of dissonance. I don’t know that the regulatory bodies have caught up to where patient
Clinical Trials in Oncology | 35
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44
