Correcting Problems of Young Clinical Investigators

William F. Crowley, Jr., M.D.Daniel K. Podolsky Professor of Medicine

Harvard Medical SchoolReproductive Endocrine Unit of the Department of Mediine

Massachusetts General Hospital

Four Horsemen of the Apocalypse of Clinical Research

ConquestThe ‘System’Clinical time

DeathTime Window

Closes

WarBasic ScientistsTransition $$

FamineLack of Funding

Loan Debts

Victor Vasnetsov, 1887

4 Popular Myths (Delusions) re Clinical Research in US

1.Pipeline

1. Myth: A robust pipeline of young clinical researcher exists:

1. Truths: It does nota. The pipeline continues to shrinkb. Many long term countervailing trends are firmly in placec. Fewer & fewer AHCs can participate

2015 Challenges for Physician Scientists Seeking Careers in Clinical Investigation

• Length of Clinical Training– Specialty 25 28– Subspeciality 28 30– Research Training 30-33 (T32)

• Loan Indebtedness $200k (2014 AAMC)• Research Training

- Research Fellowships 30 33(T32)- K Award (5 Years) 33 38

• Valley of Death = Bridge Funding for ~5-6 yrs to 1st R01– 38 -> 44 (average age of 1st R01)

• Protected Time (Departmental/Institutional)• Mentorship

• K 24 Mentors• Access to enabling platforms

Number of Awards: K08, K23 & K24 from 2005 - 2014

% NIH PIs <36 and >65: 1980-2010 Albers, et al., PNAS 112: 1912; 2015

Biological & Medical Sciences Postdocs by Degree and Citizenship/Visa Status

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Source: http://www.nsf.gov/statistics/gradpostdoc/

4 Popular Myths (Delusions) re Clinical Research in US

1. Pipeline1. Myth: A robust pipeline of young clinical researcher exists: 2. Truths: It does not

a. The pipeline continues to shrinkb. Many long term countervailing trends are firmly in placec. Fewer & fewer AHCs can participate

2. Aging Pis

1. Myth: Excess of older PIs are obstructing the advances of youth

2. Truth: Older PIs supporting many crucial administrative burdens

4 Popular Myths (Delusions) re Clinical Research in US1. Pipeline

1. Myth: A robust pipeline of young clinical researcher exists: 2. Truths: It does not

a. The pipeline continues to shrinkb. Many long term countervailing trends are firmly in placec. Fewer & fewer AHCs can participate

2. Aging PIs 1. Myth: Excess of older PIs are obstructing the advances of youth2. Truth: Older PIs supporting many crucial administrative burdens

3. Redirecting Funding

1. Myth: Limiting #s/$$ of NIH grants is a viable solution

2. Truths: 1. NIH should be a marketplace for most innovative ideas; 2. Zero sums solutions are almost always bad3. Regulatory burden making CR more and more expensive

Rescuing US biomedical research from its systemic flawsAlberts, Kirschner, Tilghman & Varmus: PNAS 111-5773, 2014

“One manifestation of this shift to shortterm thinking is the inflated value that is now accorded to studies that claim a close link to medical practice....”

“Overvaluing translational research is detracting from an equivalent appreciation of fundamental research...”

Points Made by PNAS Article

• Too many investigators competing for too few slots– True for basic but certainly not for clinical

researchers– Reflects a very focused view of manpower problem

• Pressure to publish in high impact journals viewed as big problem– Again, largely a problem for basic vs clinical

investigators

Solutions: PNAS 2014

1. Sustainable/Reliable Science Funding Plan for US going forward

2. Sustainable Enterprise Personnel Size1. Revise Training of Graduate Students & Post-Docs

3. Career Diversification1. Broader Science opportunities

4 Popular Myths (Delusions) re Clinical Research in US1. Pipeline

1. Myth: A robust pipeline of young clinical researcher exists: 2. Truths: It does not

a. The pipeline continues to shrinkb. Many long term countervailing trends are firmly in placec. Fewer & fewer AHCs can participate

2. Aging PIs 1. Myth: Excess of older PIs are obstructing the advances of youth2. Truth: Older PIs supporting many crucial administrative burdens

3. Redirecting Funding1. Myth: Limiting #s/$$ of NIH grants is a viable solution2. Truths:

1. NIH should be a marketplace for most innovative ideas; 2. Zero sums solutions are almost always bad3. Regulatory burden making CR more and more expensive

4. Future Projectionsa. Myths: The system will eventually self-correct; no long term trends involvedb. Truths: Serious/immediate action is required or we lose a generation of young Clin. Res.

Immediate “Stroke of The Pen” Solutions

Current Barriers to Pipeline• Length of Training

• Loan Indebtedness• Valley of Death Bridge• Mentorship• Protected Time• Access to Platforms

“Stroke of Pen” Solutions• Make “short tracking’ the default

training pathway for Clin. Res.• Make LRP = 80% of loans• Make K08/K23 Renewable X1• Increase K24 Awards• Insist upon 80% research for all Ks• Insist for F, T and K awards• Provide decent $ (?50k/yr) in

each T K award