While looking at the calculation formulae for compensation to be given to participants of a clinical trial, I could not resolve the mystery of this factor F. Let me demonstrate.
What is compensation in clinical trial?
Whenever a trial participant suffers an injury or disability, he or she needs to be compensated with certain amount of money.
How is it calculated?
The provision of compensation was done by inserting a new rule in Drugs and Cosmetics Rule, 1945. This new rule 122 DAB was titled “Compensation in case of injury or death during clinical trial.”
This rule dictates that it is the responsibility of the sponsor to compensate financially whenever there is a trial related injury or death. An independent expert committee proposed a formula for calculation of the compensation which is as follows:
Compensation = (B x F x R)/99.37
B = Base amount (i.e., 8 lakhs).
F = Factor depending on the age of the participant (based on Workmen’s Compensation Act).
R = Risk factor depending on the seriousness and severity of the disease, presence of comorbidity, and duration of disease of the participant at the time of enrollment in the clinical trial between a scale of 0.5 and 4 as under:
- 0.50: Critically ill patient (expected survival not more than 6 months)
- 1.0: High-risk patient (survival expected between 6 and 24 months)
- 2.0: Moderate-risk patient
- 3.0: Mild-risk patient
- 4.0: Healthy volunteers or participant of no risk.
What is factor F?
The factor F here depends on the age of the participant. If you look at the table of the factor F which is available in the appendix it goes as follows:
Click to expand table
| Age not more than | Factor F |
|---|---|
| 16 | 228.54 |
| 17 | 227.49 |
| 18 | 226.38 |
| 19 | 225.22 |
| 20 | 224.00 |
| 21 | 222.71 |
| 22 | 221.37 |
| 23 | 219.95 |
| 24 | 218.47 |
| 25 | 216.91 |
| 26 | 215.28 |
| 27 | 213.57 |
| 28 | 211.79 |
| 29 | 209.92 |
| 30 | 207.98 |
| 31 | 205.95 |
| 32 | 203.85 |
| 33 | 201.66 |
| 34 | 199.40 |
| 35 | 197.06 |
| 36 | 194.64 |
| 37 | 192.14 |
| 38 | 189.56 |
| 39 | 186.90 |
| 40 | 184.17 |
| 41 | 181.37 |
| 42 | 178.49 |
| 43 | 175.54 |
| 44 | 172.52 |
| 45 | 169.44 |
| 46 | 166.29 |
| 47 | 163.07 |
| 48 | 159.80 |
| 49 | 156.47 |
| 50 | 153.09 |
| 51 | 149.67 |
| 52 | 146.20 |
| 53 | 142.68 |
| 54 | 139.13 |
| 55 | 135.56 |
| 56 | 131.95 |
| 57 | 128.33 |
| 58 | 124.70 |
| 59 | 121.05 |
| 60 | 117.41 |
| 61 | 113.77 |
| 62 | 110.14 |
| 63 | 106.52 |
| 64 | 102.93 |
| 65 or more | 99.37 |
How do we know factor F for specific age?
This gives rise to an obvious question of where did these numbers come from? How did somebody who designed the table calculate it to the level of accuracy of 2 digits in to determine what compensation should be given to someone of specific age. I was also curious about what things were factored in when calculating such the ‘F’ for compensation.
Searching the web resources did not give much of a result. So naturally I went ahead and tried to find out the relationship between these numbers. This number is arranged in a specific order? Let us see:
Click to expand table
| Age not more than | Factor ‘F’ | Division by number below it | Substraction by number below it |
|---|---|---|---|
| 16 | 228.54 | 1.0046 | 1.05 |
| 17 | 227.49 | 1.0049 | 1.11 |
| 18 | 226.38 | 1.0052 | 1.16 |
| 19 | 225.22 | 1.0054 | 1.22 |
| 20 | 224 | 1.0058 | 1.29 |
| 21 | 222.71 | 1.0061 | 1.34 |
| 22 | 221.37 | 1.0065 | 1.42 |
| 23 | 219.95 | 1.0068 | 1.48 |
| 24 | 218.47 | 1.0072 | 1.56 |
| 25 | 216.91 | 1.0076 | 1.63 |
| 26 | 215.28 | 1.0080 | 1.71 |
| 27 | 213.57 | 1.0084 | 1.78 |
| 28 | 211.79 | 1.0089 | 1.87 |
| 29 | 209.92 | 1.0093 | 1.94 |
| 30 | 207.98 | 1.0099 | 2.03 |
| 31 | 205.95 | 1.0103 | 2.10 |
| 32 | 203.85 | 1.0109 | 2.19 |
| 33 | 201.66 | 1.0113 | 2.26 |
| 34 | 199.4 | 1.0119 | 2.34 |
| 35 | 197.06 | 1.0124 | 2.42 |
| 36 | 194.64 | 1.0130 | 2.50 |
| 37 | 192.14 | 1.0136 | 2.58 |
| 38 | 189.56 | 1.0142 | 2.66 |
| 39 | 186.9 | 1.0148 | 2.73 |
| 40 | 184.17 | 1.0154 | 2.80 |
| 41 | 181.37 | 1.0161 | 2.88 |
| 42 | 178.49 | 1.0168 | 2.95 |
| 43 | 175.54 | 1.0175 | 3.02 |
| 44 | 172.52 | 1.0182 | 3.08 |
| 45 | 169.44 | 1.0189 | 3.15 |
| 46 | 166.29 | 1.0197 | 3.22 |
| 47 | 163.07 | 1.0205 | 3.27 |
| 48 | 159.8 | 1.0213 | 3.33 |
| 49 | 156.47 | 1.0221 | 3.38 |
| 50 | 153.09 | 1.0229 | 3.42 |
| 51 | 149.67 | 1.0237 | 3.47 |
| 52 | 146.2 | 1.0247 | 3.52 |
| 53 | 142.68 | 1.0255 | 3.55 |
| 54 | 139.13 | 1.0263 | 3.57 |
| 55 | 135.56 | 1.0274 | 3.61 |
| 56 | 131.95 | 1.0282 | 3.62 |
| 57 | 128.33 | 1.0291 | 3.63 |
| 58 | 124.7 | 1.0302 | 3.65 |
| 59 | 121.05 | 1.0310 | 3.64 |
| 60 | 117.41 | 1.0320 | 3.64 |
| 61 | 113.77 | 1.0330 | 3.63 |
| 62 | 110.14 | 1.0340 | 3.62 |
| 63 | 106.52 | 1.0349 | 3.59 |
| 64 | 102.93 | 1.0358 | 3.56 |
| 65 or more | 99.37 | – | – |
It doesn’t seem like the numbers Follow an exact interval. And there are not many sources from which we can understand that this numbers come from.
Implications of the unknown
These numbers are a significant impact on how much money a sponsor or a pharmaceutical company pays out to the participants. Since the time these numbers were formulated the world has changed a lot. Although the base amount can be changed with the times, the scientific rationale for the calculation of these numbers should be known. The age-wise composition of the Indian population has also changed over the last 80 years since these numbers were calculated.
Conclusion
The current compensation payer may be over-paying or under-paying compensation to the trial participant.
Do let me know if you come across the source for calculation of these numbers.