More Elderly in Clinical Trials Response to Recommendation
TOTAL SCORE: 11
Score
A1 (Feasibility increased by continuance of pandemic): +1
A2 (Necessity increased by covid pandemic): +1
A3 (political viability): -1
B1 (Relevance to the specific goal of increasing HALE by 5 years by 2035): +1
B2 (Relevance to general goal of biomedical healthy life extension): +1
C1 (Market readiness applicability): +1
C2 (Project readiness): +1
C3 (Move to market readiness): +1
D1 (Actionability): +1
D2 (Degree of measurability): +1
D3 (Degree of leveraging cross-sector inputs): +1
D4 (Awareness of international context): 0
D5 (Resourcefulness): +1
D6 (Reorganisation): 0
E (Disruptiveness): +2
F (Dividends - does the recommendation aid in social activity and inclusivity?): -1
This recommendation earns a +2 for disruptiveness as it realistically anticipates the future restorative potential of aging biomedicine. Equal participation across all age groups in clinical trials is long overdue and necessary to uncover how aging unfolds over decades.
However, we would like to point out that many of the risks inherent in clinical trials, both in terms of patient safety and investment risk, can be eliminated with the judicious use of biomarkers.
RECOMMENDATION SUMMARY
“Historically, clinical trials excluded older people and people with multimorbidity, and some continue to do so. This is a particular issue for drugs targeting the ageing process, as older people and those with multimorbidity will be the main recipients of such drugs. (Paragraph 165)
We recommend that the Medicines and Healthcare products Regulatory Agency (MHRA) ensures that older people are included more frequently in clinical trials, particularly where the drug will be used primarily in that population. When developing novel trial designs for drugs targeting the ageing process, as recommended above, these should also allow for inclusion of people with multimorbidity. (Paragraph 166)“
Score
A1 (Feasibility increased by continuance of pandemic): +1
A2 (Necessity increased by covid pandemic): +1
A3 (political viability): -1
B1 (Relevance to the specific goal of increasing HALE by 5 years by 2035): +1
B2 (Relevance to general goal of biomedical healthy life extension): +1
C1 (Market readiness applicability): +1
C2 (Project readiness): +1
C3 (Move to market readiness): +1
D1 (Actionability): +1
D2 (Degree of measurability): +1
D3 (Degree of leveraging cross-sector inputs): +1
D4 (Awareness of international context): 0
D5 (Resourcefulness): +1
D6 (Reorganisation): 0
E (Disruptiveness): +2
F (Dividends - does the recommendation aid in social activity and inclusivity?): -1
This recommendation earns a +2 for disruptiveness as it realistically anticipates the future restorative potential of aging biomedicine. Equal participation across all age groups in clinical trials is long overdue and necessary to uncover how aging unfolds over decades.
However, we would like to point out that many of the risks inherent in clinical trials, both in terms of patient safety and investment risk, can be eliminated with the judicious use of biomarkers.
RECOMMENDATION SUMMARY
“Historically, clinical trials excluded older people and people with multimorbidity, and some continue to do so. This is a particular issue for drugs targeting the ageing process, as older people and those with multimorbidity will be the main recipients of such drugs. (Paragraph 165)
We recommend that the Medicines and Healthcare products Regulatory Agency (MHRA) ensures that older people are included more frequently in clinical trials, particularly where the drug will be used primarily in that population. When developing novel trial designs for drugs targeting the ageing process, as recommended above, these should also allow for inclusion of people with multimorbidity. (Paragraph 166)“