E-Newsletter - August 2016

Spotlight on Patient Advocacy
Resolution to Share Legacy Cancer Clinical Trial Data; a Right of Consented Patients

Many Alliance Patient Advocate Committee (PAC) members have personally participated in cancer clinical trials or have known others who have participated.  These experiences influence their perspectives on how clinical trials are conducted.  Recently, the PAC was asked their opinions regarding sharing data. Specifically, they were asked about sharing data from legacy clinical trials in a way that the data could be used and added to other similar sets of data. 

The unanimous response was that the PAC not only supported the sharing of legacy clinical trial data, but they also expected it. Patients want to make a difference and expect their participation in clinical trials to benefit all future patients. Not to do so would be a disservice to patients who voluntarily participated in clinical trials to move medical discoveries forward. This is particularly important when we know this data can be shared.

For example, Monica Bertagnolli, MD, Group Chair of the Alliance for Clinical Trials in Oncology, discussed with the PAC how the Alliance has partnered with Project Data Sphere (PDS) to make legacy Alliance trial data available to cancer researchers. PDS shares patient level clinical trial data in a way that many researchers can use, analyze and share findings to further the understanding of the outcomes of patients from these trials. The success of this initial partnership has been the driving force behind encouraging all NCTN groups to commit to share clinical trial data. The data from each trial by itself has been reported and used, but the value of combining data from many legacy trials opens up many more questions to be asked and answers to be found. The Alliance has committed to share the data from at least 20 additional clinical trials.

The PAC was energized and encouraged by the potential of sharing data from all of the NCTN groups. A coordinated and combined effort among all NCTN groups would enhance the value of the data that is currently shared. We thought it was necessary, not only to voice our opinion as patients and advocates ourselves, but to also solicit the support of other patients and advocates. To do this a resolution was drafted.

The entire PAC contributed to discussions and editing of a resolution entitled “A Resolution to Share Legacy Cancer Clinical Trial Data; a Right of Consented Patients”. To gather support, the resolution was posted on change.org and promoted through social media and e-mail. The support of other NCTN group advocates was important, so the patient advocate committee chairs were contacted and asked to distribute the resolution and to ask their group advocates if they would be willing to be listed as signers of the resolution along with the Alliance PAC members.

To date, we have received enthusiastic support of patient advocate committees from our NCTN colleagues at SWOG, ECOG-ACRIN Cancer Research Group and NRG Oncology. The resolution at change.org has more than 175 supporters from all across the U.S. and abroad.  Click here if you would like to sign the petition to show your support for the resolution.

What are the next steps? We are currently developing an implementation plan to take this resolution to those who conduct clinical trials and have data that should be shared.  We are encouraged by the cooperation of the NCTN groups to make a commitment to share data from high-impact clinical trials, so their data can be added to the data that is being shared by the Alliance.

The enthusiastic and widespread support for this resolution from a broad range of patients and advocates demonstrates the willingness and readiness of patients to share data in a way that enables medical discoveries. It is of utmost importance that this untapped resource of legacy clinical trial data continues to be shared and used so new knowledge can be discovered. The collaboration of all the NCTN groups and others who conduct clinical trials is essential to make this happen, for the benefit of all future patients.



For other articles in the August issue of the Alliance E-News newsletter, see below.