The Human Face of Clinical Trials
The language of clinical trials is indeed very clinical – data, protocols, endpoints, p-values, etc. – reflecting the scientific rigor of these tests. But it’s important to remember that they involve real people – and often patients with serious medical needs for whom the potential medicine being tested is their best hope.
Before any potential new medicine can be given to humans in clinical trials, it must go through rigorous preclinical testing for safety.
Once testing with humans begins, the highest priority must be the safety and well-being of the individual research participant. In 2003 we developed Lilly ’s Principles of Medical Research, consistent with PhRMA’s Principles on Conduct of Clinical Trials, to be followed along with the laws and regulations of the ｃountries in which the studies are conducted.
As I noted earlier, an independent team monitors safety throughout large, long-term Phase 3 trials – and it can call a halt if necessary. Stopping a trial for reasons other than safety raises a different set of issues. In such a case, we must weigh the well-being of patients enrolled in the trial and the possibility that data from completing the trial might be of overriding importance to researchers or patients.
One of the biggest challenges in clinical trials is recruiting clinical trial participants and keeping them in the study. To do this, we must remove barriers – lack of awareness, inconvenience, fears and misunderstandings – that keep people from participating in the first place. Answers to some common myths about clinical trial participation are here. We also aim to design the clinical trial experience so that volunteers will be more likely to stick to the medication regime, follow up with their doctor visits, and complete the study.
Because responses to medicines can vary due to factors that include genetics, ethnicity and lifestyle, it’s critical to have diverse representation in clinical trials. Unfortunately, minority populations have historically been underrepresented, limiting our ability to understand patient differences that may affect clinical outcomes. Our company and industry are working to increase the enrollment of racially and ethnically diverse populations in U.S. clinical trials.
Even as we focus on the patients in the clinical trial, we must never lose sight of the people who are waiting for the potential new medicine being tested. This means doing our best to conduct the trial successfully (see my previous post) and as quickly as feasible, always in keeping with Good Clinical Practice regulations.
The extensive capabilities necessary to sponsor and design clinical trials – from small Phase1 safety studies to massive Phase 3 pivotal trials – and to interpret and package trial data for regulatory submission are at the core of biopharmaceutical companies’ essential role in the innovation ecosystem. While I’ve only scratched the surface in these posts, I hope they give you a better idea of the value and importance of clinical trials, not just to our industry, but to many patients awaiting new and more effective treatments.
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VOCABULARY:
1. protocols - the official procedure or system of rules governing affairs of state or diplomatic occasions.
2. rigorous - extremely thorough, exhaustive, or accurate
3. regime - a system or planned way of doing things, especially one imposed from above
4. override - extend over overlap.
5. pivotal - of crucial importance in relation to the development or success of something else.
DISCUSSION:
1. Do you know of any clinical trial slots made available for people to volunteer for and/or to be paid for?
2. What is your opinion on the testing of experimental substances among humans?
3. What are the things that can go wrong during a cliniocal trial?
4. Can you think of any alternative to clinical trials on humans?
