Burning Topics of EVERY Clinical Trial

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What are the Burning Topics Discussed at every Clinical Trial?

Funding , drug history, Guinea pig identification, quitting, placebo concerns and trust.

These are six specific items or topics that always are discussed in clinical trial development, design and management within the industry. Let’s discuss each of these topics.

Funding

The pharmaceutical company does a great job in funding the process so funding should be taken off this list when we are discussing problems for patient participation

Drug History

The pharmaceutical company also does a fantastic job in identifying and studying the history of a drug and its complexities so that should be removed from this list.

Guinea pig & Quitting

Being a Guinea pig is an extremely sensitive topic and that should remain on the list. This is a true fear that is raised time and time again, particularly within the African American community, and rightfully so. Stopping at any time is not a problem because industry trends indicate that dis-engagement (quitting) hovers at a rate close to 40%. But should we remove  this from the list?

Placebos & Trust

Placebos are a big issue which goes back to the education and understanding of a clinical trial process. Trust is the component of educating the people knowing they’re not a Guinea pig and understanding placebo versus study therapies. These seem to be the recurring problems that we need to address.

So, what are the real issues that surround poor patient recruitment, engagement, and retention? Is aversion the culprit for reduced patient recruitment in a clinical trial? Articles, documents, research, papers, reports, presentations even conferences are all designed around the concept that patients have an aversion to clinical trials. The experts feel that patients are afraid. I disagree. Is it fear or is it simply they don’t know? What is their knowledge about and towards clinical trials.

The majority of people learn about a clinical trial through their doctor.  People trust their doctor. But many doctors do not refer patients to clinical trials. One possible explanation is that clinicians do not have all of the information. This is not a lack of knowledge, but rather the purpose of a clinical trial. When a clinical trial is conducted, we simply do not have all of the answers. And the way by which we communicate this message to the potential patient could make or break that person’s decision to participate in the clinical trial. Empathy, calmness, and patience are key at this point. But physicians are on a timeclock and therefore they may not have the time to communicate the trial in the manner that each unique patient needs to hear. But shouldn’t this be one of the elements of personalized medicine, time?

Another report indicates that patients view participation in the clinical trial as a negative option. Why would it be negative should be the question? The negativity comes from mistrust. Where is the mistrust from? Is this the Guinea pig syndrome or lack of empathy or lack of time?

Perhaps the issue is not a lack of interest or lack of trust but perhaps it’s lack of education, education for both the physician and the patient. If we investigate the true comprehension that both physicians and patients have about the process of a clinical trial participation, we would likely discover that neither party may really appreciate the amount of work that is required to be a successful participant as well as provider to run and manage a successful clinical trial.

What is the solution? We teach, we raise awareness, we assist, to be sure that potential patients want to participate in clinical trials and physicians clearly understand the commitment process too. Engagement is a 2-way process that benefits by open, honest dialogue among patients and doctors. By incorporating empathy, we can better address these issues and the opportunity to reframe our recruitment approach in a human-centric way by starting with a patient’s concerns not a diagnostic code.

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