Brainstorming a path to robust, global guidelines for clinical trials
How a clinical trial is run, how its data is shared, and what post-trial responsibilities the sponsors have to clinical trial participants varies depending on the country, industry and therapeutic area of that trial (among other things). This leads to inconsistency between how trials are designed, how widespread the data are shared, and to what extent research participants receive treatment after the trial is completed. In light of this, these challenges have led to calls for a comprehensive document that develops standards, establishes best practices, identifies improvement areas and improves data transparency to participants in clinical trials.
The Multi-Regional Clinical Trials (MRCT) Center, an initiative of the Brigham and Women’s Hospital and Harvard University, is responding to this need. It hosts regular brainstorming sessions with clinical trial specialists from academia, industry, government, regulatory bodies, and interested parties from not-for-profit organizations, NGO’s, foundations, and patient advocacy groups. Since the initiative’s inception, participants have tried to formulate universal standards for clinical trials. At the moment, Brazil holds the gold standard for robust ethical guidelines on running clinical trials, in that they clearly mandate that research sponsors must continue to provide medicines to the patients who participated in their trials after the trials have ended. But in this, Brazil is the exception.
The MRCT group’s challenge is in taking mandates like this and turning them into practical, actionable and enforceable strategies for clinical trial researchers everywhere. In March of last year, the group’s members decided to create a new not-for-profit organization to achieve these goals through building a sustainable data-sharing platform.
In parallel, MRCT members are also focusing on improved data transparency. At the group’s most recent meeting last December, it launched a project to return results to research study participants (i.e. patients enrolled in clinical trials) with “plain language summaries of the outcomes of the trial.” Patient privacy would be safeguarded, data would be interoperable (a major technological advance that is currently being pushed by President Obama’s Precision Medicine Initiative), and clinical trial registration and data reporting would, theoretically, be standardized.
The focus on transparency received enthusiastic support from one of the patient advocates attending the meeting. Elizabeth Frank, a cancer survivor and Dana Farber Cancer advocate really liked the approach because these documents would provide up-front expectations early in the process to all stakeholders – researchers, physicians and patients. Moreover, the MRCT group’s effort to return patient results to individuals enrolled in clinical trials strongly aligns with the AllTrials mission. If successful, this initiative to increase trial transparency would be a huge step toward clarifying the impact and importance of the clinical trial results to the public and those enrolled in future trials.
Others were more critical of the MRCT’s draft guidelines for clinical trials. Dr. Christine Grady, a nurse-bioethicist and chief of the department of bioethics at the National Institutes of Health Clinical Center, relayed unease about how the proposed global document would handle informed consent: “I have concerns about changes that occur during the course of the trial. I think there needs to be some thought about ‘what do we need to tell people?’ I think we need engagement with the participants at the front end and along the way.”
Elizabeth Frank echoed Dr. Grady’s point saying, “I would like to see examples of informed consent. It is not easy to write an informed consent. I would emphasize patient-friendly consent forms. And discussion to the barriers, because there are many barriers to making a patient friendly consent form.” While not yet resolved, this area will be tackled by the MRCT group in future iterations of the global guidance documents.
This promotion of trial transparency combined with more informative participant consent forms would help to rebuild public confidence in clinical trials—damaged by repeated scandals—and hopefully lead more patients to volunteer for novel medical therapies. Simultaneously, it would hold pharmaceutical developers and other countries to a high level of expectations in their clinical trial design, implementation, and compliance.