Oxford Conference Looks at Sensible Approach to Clinical Trials

Oxford University

Nancy Roach is the Founder of C3 and Chair of the Board of Directors.

On September 5 -6, I put on my sensible black shoes to attend the second Sensible Guidelines for the Conduct of Clinical Trials meeting at Oxford University in England.  This invitation-only meeting convened research leaders to discuss how to improve large randomized clinical trials.

Why “Sensible Guidelines”?

People are the ‘experimental subjects’ of clinical research. Since World War II, laws and regulations have been passed to make sure that research participants are protected during the conduct of clinical trials. Over time – and especially in the last decade – many of the well-meaning laws and regulations have had an unintended consequence:  bureaucracy that does not always protect or help patients, but does eat up resources. Patients in trials often see only the tip of the bureaucratic iceberg, while research staff, academic institutions, government agencies and drug companies struggle with the rest of it.

For example, trials require that investigators show that they are credible researchers, and often include a criminal background check.  This sounds very reasonable; however, when researchers participate in multiple trials, the same paperwork is required multiple times.  In England, researchers are now issued “passports” that certify their credentials.  Once they are certified, they don’t need to re-apply for each trial.  This simple step saves time and paperwork.  The saved time allows researchers and their staff to spend more time with patients and conducting research.

Patient protection is central to all clinical research.  The goal of the Sensible Guidelines group is to support regulations and practices that promote meaningful patient protection and safety while not adding unnecessary paperwork or extra rules that only slow down research.

Meeting Report

After the first Sensible Guidelines meeting in 2007, several papers were published in the February 2008 issue of Clinical Trials (pages 38-84. A subscription is required to read the full text) that documented the impact of unhelpful bureaucracy, and suggested ways to reduce it.

The second meeting’s goals this September were to:

• Update the review of the main barriers preventing efficient trials;
• Share the experiences of those who are attempting to deal with these barriers; and
• Agree on possible solutions to the main difficulties and encourage their promotion through international collaboration.

I was the only patient advocate invited and was a little worried that I would be a ‘lone voice’ for patients.  Once the meeting started, I realized I didn’t need to worry.  I was struck by the passion of everyone involved, and their frustration with today’s reality. They want:

• trial monitoring which monitors patient safety;
• informed consents that help patients understand the trial and its risks and benefits; and
• adverse event reporting that reveals meaningful side  effects.

More than anything else, they want to see time and money going into patients and research projects instead of process and paperwork which doesn’t add to the value of the research.   Once again, I was reminded that many people involved with clinical research can also be advocates for patients.

Some meeting highlights for me:

• Progress was reported from the “bureaucracy-busting” work led by Dr. Sally Davies in England.  The Best Research for Best Health effort was lauded by many in the audience as saving time and energy for patients and researchers.

• Dr. Judith Kramer presented the work being done by the FDA-Duke Clinical Trials Transformation Initiative (CTTI).  CTTI is conducting research to identify best practices in adverse event reporting and clinical trial monitoring.

• Dr. Zhang Jingli, Deputy Commissioner of China’s State Food and Drug Administration, described how the Chinese version of our Food and Drug Administration (FDA) regulates drug safety.   The complexity was astounding  given China’s size, growth and mix of both traditional and Western medicines.

Nancy Roach Chair C3 Board

Changing the way research is conducted is complicated.  At the end of the meeting, participants puzzled over exactly what steps are necessary.  A small group will develop recommendations, and proposals for sensible monitoring of trials will be published.

C3 is involved with several ongoing efforts to streamline research, including the National Cancer Institute, CTTI and Brookings /Friends of Cancer Research.  So stay tuned!