November 20, 2000 Clinical Trials Questions (from a Physician's Viewpoint) M.J.McKeown, MD, FACOG, FACS

This above all: To thine ownself be true, And it must follow, as the night the day, Thou canst not then be false to any man.
Polonius/Hamlet/Shakespeare

I have done clinical investigations and in all honesty I am not sure I followed the guidelines I am going to write... The investigator has 8 general questions to answer before undertaking any clinical trial.

1. Am I willing to commit myself and enough of my resources to do a good, conscientious job?

2. Do I have the personal skills and resources to do a good conscientious job?

3. Do I want to do a minimal job for maximum profit to me and my institution?

4. Is the model to be evaluated sound clinically?

5. Is the model to be evaluated sound statistically?

6. Is the model to be evaluated mostly political in a social or economic sense?

7. What are the motives and goals of those initiating the study and what are my personal, professional, institutional and/or political motives and goals and can I live with the answer to these questions?

8. What must I do to protect myself and my institution from legal attack?

I believe that all clinical trials are done by people who believe in answering the questions posed above. However, I am not sure all investigators answer these questions.

I also offer the following checklist of things to consider when studying any clinical trial proposal.

What Is Being Studied?

• Nutrition
  • Add
  • Delete

• Environment
  • Personal Control
  • Group Control

• Medications
  • Legal (nicotine,alcohol,etc)
  • Illegal (numerous)
  • Prescription (numerous)

• Procedures
  • Exercise Routines
  • Personal
  • Group

• Consciousness Modification
  • Personal
  • Group

• Clinical Medications
  • Discrete Event Therapy
  • Longterm Condition Therapy

• Clinical Procedures
  • Discrete Problem Resolution
  • Longterm Condition Therapy

Who Sponsors The Study?

• Organizations
  • Consumer
  • Professional
  • Membership Required
  • Membership Not Required

• Producers/Suppliers of What is Being Tested
  • Government -funded
  • Private - funded
  • For Profit Organization
  • Not-for-Profit Organization

• Political Forces Involved
  • Local
  • State
  • Federal
  • International

• Severity of Condition Studied
  • Life Threatening
  • Quality of Life Threatening
  • Who Participates In The Study

• Expected Outcome
  • Participants Will Not Survive but Knowledge is Gained
  • An Acceptable Percentage of Participants Will Survive (who defines what is acceptable?) or Have Their Quality of Life Improved

• What are Your Costs?
  • Direct Indirect (experts, statisticians, laboratories, etc)

• Reimbursement Philosophy
  • Break Even
  • Support Other Tasks
  • Make a Profit

This is not a complete list, but each category could expand to fill many pages. A competent, conscientious healthcare investigator should be able to expand each category to fit the unique problem they contemplate studying.

The single, most important decision the investigator makes is to decide if the proposal will not harm the subject. Primum Non Nocere! It is certainly true that leading edge development is not without risk. Unfortunately the legal liability industry awaits around every corner of the investigator's universe, like hungry crocodiles.

Three personal factors should be the basis of one's decision.

1. Primum Non Nocere
2. Do I truly believe this is more helpful than hurtful?
3. Have I erected sufficient legal defenses?

Finally, Never Forget The Study Participants! It is obvious that many will be emotionally fragile. Many are facing death. In pain and discomfort, the participants will want to view the investigator with hope and trust. This is the most important function of the investigator. Support The Participant, physically and emotionally. The good investigator accepts this role of healer and continues to support the participant even if the results are not as good as desired. I can think of few more psychologically devastating things than for a clinical trials participant to feel rejection from their healer if the results are not good. It can make the participant feel they have failed, and the therapy. To abandon the study participant if the results are not as wished, is abhorrent, uncaring and certainly does not follow Primum Non Nocere!

In summary, it should be remembered by all potential investigators that one takes on many professional and personal obligations in doing any study. Ultimately the believability of the results of any investigation will depend upon the integrity and reputation of the investigator.

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